Proposal for a Directive of the European Parliament and of the Council on measuring instruments
Date: 2000-09-15
Institutions: European Commission
Subjects: EC conformity marking, approximation of laws, harmonisation of standards, measuring equipment, metrology

27.2.2001

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Official Journal of the European Communities

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II

(Preparatory Acts)

COMMISSION

Proposal for a Directive of the European Parliament and of the Council on measuring instruments

(2001/C 62 E/01)

(Text with EEA relevance)

COM(2000) 566 final (cid:25) 2000/0233(COD)

(Submitted by the Commission on 15 September 2000)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of
Committee,
Acting in accordance with the procedure laid down in Article
251 of the Treaty,
Whereas:

the Economic and Social

(1) A number of measuring instruments are covered by
specific Directives, adopted on the basis of Directive
71/316/EEC on common provisions for both measuring
instruments and methods of metrological control (1).
Specific directives that are technically outdated should
be repealed and replaced by an independent directive,
which is in the spirit of Council Resolution of 7 May
1985 on a new approach to technical harmonisation
and standards (2).
that
are not
by Directive
should
outdated
71/316/EEC.

Specific Directives
governed
remain

(2) Measuring instruments can be used for a variety of
measurement
tasks. Those responding to reasons of
public interest, affecting the daily life of citizens in
many ways directly and indirectly, require the use of
legally controlled measuring instruments.

(3) Legal metrological control should not lead to barriers to
the
free movement of measuring instruments,
the
provision concerned should be the same in all Member
States and proof of conformity accepted throughout the
Community.

control

requires

(4) Legal metrological

conformity with
specified performance requirements. The performance
requirements that the measuring instruments must meet
should provide a high level of protection. The assessment
of conformity should provide a high level of confidence.
(5) The performance of measuring instruments is particularly
sensitive to the electromagnetic environment. Immunity
of measuring instruments to electromagnetic interference
forms an integral part of this Directive and the immunity
requirements
of Council Directive 89/336/EEC of
3 May 1989 on electromagnetic compatibility (3), as last

should

legislation

amended by Directive 93/68/EEC (4), would therefore not
apply.
(6) Community

essential
requirements that do not impede technical progress. The
be
legal
performance
remove
should follow the new
technical barriers
approach provided for
in the Council Resolution of
7 May 1985 on a new approach to technical harmon-
isation and standards.

requirements. Regulations

requirements

preferably

to trade

therefore

specify

should

to

technical

and performance

(7) European technical standards should therefore be drawn
specifications
up whose
comply with the essential requirements laid down by
this Directive. Conformity with the specifications of
those standards would give rise to a presumption of
conformity with the essential requirements laid down by
this Directive. Standards harmonised at European level are
drawn up by private bodies and must
retain their
non-mandatory status. For this purpose,
the European
Committee for Standardisation (CEN) and the European
Committee for Electrotechnical Standardisation (Cenelec)
are recognised as being the bodies that are competent to
adopt harmonised standards
follow the general
guidelines for cooperation between the Commission and
those two bodies signed on 13 November 1984.

that

to be carried out at

the request of
to Directive 98/34/EC of

(8) The drawing up of harmonised standards by CEN and
the
Cenelec is
the
Commission pursuant
the Council of 22 June
European Parliament and of
the provision of
1998 laying down a procedure for
information in the field of technical standards and regu-
lations and of rules on Information Society services (5), as
amended by Directive 98/48/EC (6). In relation to stan-
is advisable for the Commission to be
dardisation,
set up under Directive
assisted by the Committee
98/34/EC. The Committee will,
if necessary, consult
technical experts.

it

of

(9) In certain specialised fields the technical and performance
normative
internationally
specifications
documents can also comply, in part or in full, with the
product specifications laid down in legislation. In those
cases the use of these internationally agreed normative
documents can be an alternative to the use of European
technical standards.

agreed

(1) OJ L 202, 6.9.1971, p. 1.
(2) OJ C 136, 4.6.1985, p. 1.
(3) OJ L 139, 23.5.1989, p. 19.

(4) OJ L 220, 30.8.1993, p. 1.
(5) OJ L 204, 21.7.1998, p. 37.
(6) OJ L 217, 5.8.1998, p. 18.

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(10) Conformity with the essential requirements laid down by
this Directive can also be provided by specifications that
are not supplied by a European technical standard or
internationally agreed normative document. The use of
European technical standards or internationally agreed
normative documents should therefore be optional.

(11) The state of the art in measurement technology is subject
to constant evolution which may lead to changes in the
needs for conformity assessments. Therefore,
for each
category of measurement there must be an appropriate
procedure or a choice between different procedures of
equivalent stringency. The procedures adopted are as
required by Council Decision 93/465/EEC of 22 July
1993 concerning the modules for the various phases of
the conformity assessment procedures and the rules for
the affixing and use of the CE conformity marking, which
are intended to be used in the technical harmonisation
Directives (1).

(12)

for

the Council Decision
In accordance with Article 2 of
1999/468/EC of 28 June 1999 laying down the
procedures
implementing powers
conferred on the Commission (2), measures necessary for
the implementation of this Directive should be adopted by
use of the advisory procedure provided for in Article 3 of
that Decision.

the exercise of

(13) The Member States should actively survey their markets
to non-complying
and take all appropriate measures
instruments
from being placed on their markets or
being used. Adequate cooperation among the market
surveillance
is
of
therefore necessary to ensure a Community-wide effect
of the market surveillance activities.

the Member

authorities

States

(14) Member States should take all appropriate measures to
ensure that measuring instruments that carry the CE
conformity marking and supplementary marking are
correctly placed on the market. Manufacturers should be
informed of the grounds on which negative decisions in
their products were taken, and the legal
respect of
remedies available to them.

(15) This Directive should repeal the Community legislation in
the measuring instruments covered by the

respect of
following Council Directives:

> 71/318/EEC of 26 July 1971 on the approximation of
the laws of
relating to gas
the Member States
meters (3), as last amended by Commission Directive
82/623/EEC (4);

(1) OJ L 220, 30.8.1993, p. 23.
(2) OJ L 184, 17.7.1999, p. 23.
(3) OJ L 202, 6.9.1971, p. 21.
(4) OJ L 252, 27.8.1982, p. 5.

> 71/319/EEC of 26 July 1971 on the approximation of
the laws of the Member States relating to meters for
liquids other than water (5);

> 71/348/EEC of 12 October 1971 on the approxi-
mation of the laws of the Member States relating to
ancillary equipment for meters for liquids other than
water (6), as last amended by the Act of Accession of
Austria, Finland and Sweden;

> 73/362/EEC of 19 November 1973 on the approxi-
mation of the laws of the Member States relating to
length (7), as last amended by
material measures of
Commission Directive 85/146/EEC (8);

> 75/33/EEC of 17 December 1974 on the approxi-
mation of the laws of the Member States relating to
cold water meters (9);

> 75/410/EEC of 24 June 1975 on the approximation of
the laws of the Member States relating to continuous
totalising weighing machines (10);

> 76/891/EEC of 4 November 1976 on the approxi-
mation of the laws of the Member States relating to
electrical energy meters (11);

> 77/95/EEC of 21 December 1976 on the approxi-
mation of the laws of the Member States relating to
taximeters (12);

> 77/313/EEC of 5 April 1977 on the approximation of
the laws of the Member States relating to measuring
systems for liquids other than water (13) as amended
by Commission Directive 82/625/EEC (14);

> 78/1031/EEC of 5 December 1978 on the approxi-
mation of the laws of the Member States relating to
automatic
grading
machines (15);

checkweighing

and weight

> 79/830/EEC of 11 September 1979 on the approxi-
mation of the laws of the Member States relating to
hot-water meters (16).

(5) OJ L 202, 6.9.1971, p. 32.
(6) OJ L 239, 25.10.1971, p. 9.
(7) OJ L 335, 5.12.1973, p. 56.
(8) OJ L 54, 23.2.1985, p. 29.
(9) OJ L 14, 20.1.1975, p. 1.
(10) OJ L 183, 14.7.1975, p. 25.
(11) OJ L 336, 4.12.1976, p. 30.
(12) OJ L 26, 31.1.1977, p. 59.
(13) OJ L 105, 28.4.1977, p. 18.
(14) OJ L 252, 27.8.1982, p. 10.
(15) OJ L 364, 27.12.1978, p. 1.
(16) OJ L 259, 15.10.1979, p. 1.

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(16) Manufacturers should be offered the possibility to exercise
the rights obtained before the entry into force of this
Directive,
reasonable period. Transitional
arrangements are therefore necessary,

during

a

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

SCOPE AND OBJECT

Article 1

Scope

This Directive applies to the devices and systems with a
measuring
specific
annexes MI-001 to MI-011.

function defined

instrument

in the

Article 2

Object

This Directive establishes the essential requirements that the
devices and systems referred to in Article 1 have to satisfy if
in a Member
they are subject to legal metrological control
they have to
that
State, and the conformity assessment
undergo in those circumstances, with a view to their placing
on the market and putting into use.

It is a specific Directive in respect of requirements for electro-
magnetic immunity in the sense of Article 2(2) of Directive
89/336/EEC.

CHAPTER II

LEGAL METROLOGICAL CONTROL

Article 3

Definitions

For the purposes of this Directive:

(a) Ameasuring instrumentB means any device or system with a
measurement function that is covered by the scope and
object of this Directive, as laid down in Articles 1 and 2;

(b) Asub-assemblyB means a hardware device that functions inde-
pendently and together with other sub-assemblies with
which it is compatible, makes up a measuring instrument;

(c) Alegal metrological controlB means

the
measurement tasks of a measuring instrument, prescribed
by the Member States for reasons of public health, public
safety, public order, protection of the environment, levying
of taxes and duties, protection of the consumers and fair
trading;

the control of

(d) AmanufacturerB means the physical or legal person who

> carries out

the

technical design of a measuring

instrument, or has it carried out on his behalf, and

> manufactures

the measuring instrument, or has

it

manufactured on his behalf, and

> places it lawfully on the market under his own name,

or,

the physical or legal person who

> takes responsibility for the conformity of the measuring
this

to the appropriate requirements of

instrument
Directive, and

> has taken all necessary measures to bear those respon-

sibilities, and

> places the measuring instrument lawfully on the market

under his own name;

(e) Aplacing on the marketB means the first passing of

the
from the stage of manufacture to the stage of

product
distribution and/or use on the Community market;

(f)

Aputting into useB means the first use of a product for the
purposes for which it was intended;

(g) Aauthorised representativeB means

legal
in writing,
person who is authorised by a manufacturer,
to act on his behalf
for specified tasks. An authorised
representative must be established within the Community
if he is to act under this Directive;

the physical or

(h) Aharmonised standardB means a technical

specification
adopted by the European Committee for Standardisation
(CEN) or the European Committee for Electrotechnical Stan-
dardisation (Cenelec) or jointly by both, at the request of
the Commission pursuant
to Directive 98/34/EC, and
prepared in accordance with the General Guidelines
agreed between the Commission and the European
standards organisations;

(i)

Anormative documentB means
containing
normative elements drawn up by the Organisation Inter-
nationale de MØtrologie LØgale.

a document

Article 4

Essential requirements and assessment of conformity

A measuring

1.
essential
requirements laid down in Annex I and the relevant instrument
specific Annex.

shall meet

instrument

the

2.
The conformity of a measuring instrument with the
essential requirements shall be assessed in accordance with
the provisions of Article 7.

3. Where a measuring instrument consists of a number of
sub-assemblies and where specific annexes exist laying down
the essential requirements for all of these sub-assemblies that
together make up the measuring instrument, the provisions of
this Directive shall apply mutatis mutandis to each of these
sub-assemblies.

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Article 5

Conformity marking

Article 8

Notification

1.
The conformity of a measuring instrument with all the
obligations contained in this Directive shall be indicated by the
presence on it of
the CE conformity marking and the
supplementary metrology marking as specified in Article 13.

The CE

2.
supplementary
metrology marking shall be affixed by, or under the responsi-
bility of the manufacturer.

conformity marking

and

3.
The affixing of markings on a measuring instrument that
are likely to deceive third parties as to the meaning and form
of the CE marking or the supplementary metrology marking
shall be prohibited. Any other marking may be affixed to a
measuring instrument, provided that the visibility and legibility
of the CE marking and the supplementary metrology marking
is not thereby reduced.

Article 6

Placing on the market and putting into use

1. Without prejudice to the provisions of Articles 13 and
14, Member States shall not impede for reasons covered by this
Directive the placing on the market and putting into use of any
measuring instrument that carries the CE conformity marking
and supplementary metrology marking in accordance with
Article 5.

that carries

2. Member States shall ensure that the use of any measuring
instrument
the CE conformity marking and
supplementary metrology marking in accordance with Article
5 shall not be impeded by rules or conditions in respect of
aspects covered by this Directive which are imposed by
the relevant activities, as
contracting entities in pursuit of
referred to in Article 2 of Council Directive 93/38/EEC (1).

CHAPTER III

ASSESSMENT OF CONFORMITY

Article 7

Assessment of conformity

Assessment of conformity of a measuring instrument with its
essential requirements shall be carried out by the application,
at the choice of the manufacturer, of one of the conformity
assessment procedures listed in the specific annex concerning
that instrument.

The conformity assessment modules making up the procedures
are described in Annexes A to H1.

(1) OJ L 199, 9.8.1993, p. 84.

1. Member States shall notify to the other Member States
and the Commission the bodies which they have designated to
carry out the tasks pertaining to the conformity assessment
modules referred to in Article 7, together with the identifi-
cation numbers given by the Commission according to
paragraph 4, the kind(s) of measuring instrument for which
each body has been designated and in addition, where relevant,
the instrument classes, the measuring range, the measurement
technology, and any other instrument characteristic limiting the
scope of the notification.

2. Member States shall apply the criteria set out in Annex III
for the designation of such bodies.

A Member State that has notified a body shall withdraw
3.
such notification if it finds that the body no longer meets the
criteria referred to in paragraph 2. It shall forthwith inform the
other Member States and the Commission of any such with-
drawal of a notification.

list of bodies notified,

4.
Each of the bodies to be notified shall be given an identi-
fication number by the Commission. The Commission shall
together with the
publish the
the notification
information in respect of
referred to in paragraph 1,
the Official
Journal of the European Communities and shall ensure that the
list is kept up to date.

the scope of
in the C series of

CHAPTER IV

PRESUMPTION OF CONFORMITY

Article 9

Harmonised standards and normative documents

1. Member States
conformity with the
shall presume
essential requirements referred to in Article 4 in respect of a
measuring instrument that complies with the elements of the
national standards implementing the European harmonised
standard for that measuring instrument
that correspond to
those elements of this European harmonised standard whose
references have been published in the C series of the Official
Journal of the European Communities.

Where a measuring instrument complies only in part with the
the national standards referred to in the first
elements of
subparagraph, Member States shall presume conformity with
the essential requirements corresponding to the elements of the
standards with which the instrument complies.

Member States shall publish the references of
standards referred to in the first subparagraph.

the national

conformity with the
shall presume
2. Member States
essential requirements referred to in Article 4 in respect of a
measuring instrument
that complies with the normative
document referred to in Article 11(2)(c), whose references
have been published in the C series of the Official Journal of
the European Communities.

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Where a measuring instrument complies only in part with the
normative document referred to in the first subparagraph,
Member States shall presume conformity with the essential
requirements corresponding to the normative elements with
which the instrument complies.

Member States shall publish the references of the normative
document referred to in the first subparagraph.

CHAPTER V

COMMITTEES

Article 10

Committee on standards and technical regulations

Where a Member State or the Commission considers that a
European harmonised standard as referred to in Article 9(1)
does not fully meet the essential requirements referred to in
Article 4, the Member State or the Commission shall bring the
matter before the Standing Committee set up under Directive
98/34/EC, giving its reasons for doing so. The Committee shall
deliver an opinion without delay.

In the light of the Committee’s opinion, the Commission shall
inform the Member States whether or not it is necessary to
withdraw the references of the national standards from the
publication referred to in the third subparagraph of Article
9(1).

Article 11

Measuring Instruments Committee

(b) amend the test programmes laid down in Annex II;

(c) request

the Organisation Internationale de MØtrologie
LØgale to draw up a normative document containing
conformity with which provides
normative
presumption of
corresponding
essential requirements of this Directive;

conformity with the

elements

(d) publish the references of the normative document referred
to in point (c) in the C series of the Official Journal of the
European Communities.

2. Where a Member State or the Commission considers that
a normative document whose references have been published
in the C series of the Official Journal of the European Communities
in accordance with paragraph 2(d), does not fully meet the
essential requirements referred to in Article 4, that Member
State or the Commission shall bring the matter before the
for
Measuring Instruments Committee, giving its
doing so.

reasons

The Commission, acting in accordance with the procedure
inform the Member States
referred to in Article 11(2), shall
whether or not it is necessary to withdraw the references of
the normative document concerned from the publication
referred to in the third subparagraph of Article 9(2).

CHAPTER VI

MARKINGS

Article 13

Markings

The Commission shall be

1.
assisted by a Standing
Committee, the Measuring Instruments Committee, composed
of representatives of the Member States and chaired by the
representative of the Commission.

1.
The CE conformity marking referred to in Article 5
consists of the letters CE according to the design laid down
in paragraph I.B(d) of the Annex to Decision 93/465/EEC. The
CE marking shall be at least 5 mm high.

2. Where reference is made to this paragraph, the advisory
procedure laid down in Article 3 of Decision 1999/468/EC
shall apply,
in compliance with Article 7(3) and Article 8
thereof.

Article 12

Functions of the Measuring Instruments Committee

On request by a Member State or on its own initiative,
1.
the Commission, acting in accordance with the procedure
referred to in Article 11(2), may take any appropriate
measure to:

(a) amend instrument specific annexes in respect of:

> the maximum permissible errors and accuracy classes,

> the rated operating conditions,

> the critical change values,

> the list of conformity assessment procedures referred to

in Article 7;

The supplementary metrology marking referred to in
2.
Article 5 consists of the capital
letter M and the year of its
affixing, surrounded by a rectangle. The height of the rectangle
shall be equal to the height of the CE conformity marking. The
supplementary metrology marking shall immediately follow the
CE conformity marking.

The identification number of the notified body concerned
3.
if prescribed by the conformity
referred to in Article 8,
conformity
assessment procedure,
marking
The
and
measuring instrument shall carry no identification number of
a notified body where that is not prescribed by the conformity
assessment procedure.

supplementary metrology marking.

follow the CE

shall

4. When a measuring instrument consists of a set of devices
operating together,
the markings shall be present on the
instrument’s main device.

When a measuring instrument is too small or too sensitive to
carry the markings referred to in paragraph 1, the markings
shall be carried by the packing in which the instrument is
offered for sale or, if applicable, the container in which the
instrument is supplied.

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The CE

conformity marking

supplementary
5.
metrology marking shall be
identification
number of the notified body concerned shall be indelible or
self destructive upon removal. All markings shall be clearly
visible or easily accessible.

indelible. The

and

Article 14

Market surveillance

that

carry

that measuring

take all appropriate measures to
1. Member States shall
ensure
the CE
instruments
conformity marking and supplementary metrology marking
according to Article 5 shall be placed on the market and put
into use only if, when correctly installed and used in
accordance with the manufacturer’s instructions, they satisfy
the essential requirements referred to in Article 4, and they
in accordance with
have undergone conformity assessment
Article 7.

The competent authorities of the Member States shall
their obligations to

2.
assist each other in the fulfilment of
carry out market surveillance.

the

competent

In particular,
exchange
information concerning the extent to which instruments they
examine comply with the obligations of this Directive, and the
results of such examinations.

authorities

shall

Each Member State shall inform the other Member States and
the Commission which competent authorities it has designated
for such exchange of information.

Information exchanged shall be kept confidential.

3.
the
If a Member State establishes that all or part of
measuring instruments of a particular model that bear the
CE conformity marking and the supplementary metrology
marking do not satisfy the conditions set out in paragraph 1,
it
to withdraw those
instruments from the market, prohibit or restrict their further
being placed on the market, or prohibit or restrict their further
being used.

take all appropriate measures

shall

the

systematic or

When deciding on the measures, the Member State shall take
the
account of
non-compliance. Where the Member State has established
that
it shall
immediately inform the Commission of the measures taken,
indicating the reasons for its decision.

the non-compliance is of a systematic nature,

incidental nature of

The Commission shall enter into consultation with the

4.
parties concerned as soon as possible.

take appropriate action
The competent Member State shall
against whomsoever has affixed the markings and shall
inform the Commission and the other Member States thereof.

Should the Commission find that the measures taken by the
Member State concerned are not justified, it shall immediately
inform the Member State that took the action thereof, as well
as the manufacturer concerned or his authorised representative.

the non-compliance is attributed to shortcomings in the
If
standards, the Commission shall, after having consulted the
parties concerned, bring the matter as
soon as possible
before the Committee referred to in Article 10.

The Commission shall ensure that the Member States are kept
informed of the progress and outcome of the procedure.

CHAPTER VII

GENERAL AND FINAL PROVISIONS

Article 15

Decisions entailing refusal or restriction

Any decision taken by a Member State pursuant
to this
Directive which requires the withdrawal from the market of
a measuring instrument, or prohibits or restricts the placing
on the market or putting into use of an instrument, shall state
the exact grounds on which it is based. Such a decision shall be
notified forthwith to the party concerned, who shall at the
same time be informed of the legal remedies available to him
under the laws in force in the Member State concerned and of
the time limits to which such remedies are subject.

Article 16

Repeals

The following Directives are repealed as from (1 July 2002)
without prejudice to Article 17:

> Directive 71/318/EEC;

> Directive 71/319/EEC;

> Directive 71/348/EEC;

> Directive 73/362/EEC;

> Directive 75/33/EEC;

> Directive 75/410/EEC;

> Directive 76/891/EEC;

> Directive 77/95/EEC;

> Directive 77/313/EEC;

Should the Commission find that the measures taken by the
Member State concerned are justified,
immediately
inform the Member State that
took the action thereof, as
well as the other Member States.

it shall

> Directive 78/1031/EEC;

> Directive 79/830/EEC.

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Article 17

Transitional provisions

By way of derogation from Article 18(2), Member States shall
permit, for measurement tasks for which they have prescribed
the use of a legally controlled measuring instrument,
the
placing on the market and putting into use of measuring
instruments that satisfy the rules applicable before (1 July
the expiration of
the type
2002) until
approval of
in case of a
those measuring instruments or,
type approval of indefinite validity, for a period of ten years
from (1 July 2002).

the validity of

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of
their official publication.
Member States shall determine how such reference is to be
made.

Article 19

Entry into force

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

Article 18

Transposition

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by (1 July 2002) at the latest. They shall forthwith
inform the Commission thereof.

Article 20

Addressees

This Directive is addressed to the Member States.

ANNEX I

ESSENTIAL REQUIREMENTS

A measuring instrument shall provide a high level of metrological protection in order that any party affected can have
confidence in the result of measurement, and shall be designed and manufactured to a high level of quality in respect of
the measurement technology and security of the measurement data.

The requirements that shall be met by measuring instruments to provide these objectives are set out below and are
completed, where appropriate, by specific instrument requirements in Annexes MI-001 to MI-011 that provide more
detail on certain aspects of the general requirements.

The solutions adopted in the pursuit of the requirements shall take account of the intended use of the instrument and
reasonably foreseeable misuse.

Instruments are deemed to satisfy the relevant aspects of requirements if manufacturers can demonstrate that the
corresponding test programme(s) of Annex II has/have been performed and gave appropriate results.

DEFINITIONS

Measurand

The measurand is the particular quantity subject to measurement.

Influence quantity

An influence quantity is a quantity that is not the measurand but that affects the result of measurement.

Rated operating conditions

The rated operating conditions are the values for the measurand and influence quantities making up the normal working
conditions of an instrument.

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Disturbance

A disturbance is an influence quantity not normally making up the working conditions of the instrument for which
values and performance requirements are prescribed.

Critical change value

The critical change value is the value at which the change in the measurement result is considered undesirable. The
value is expressed in the unit of measurement in which the measurement result itself is expressed.

Material measure

A material measure is a device, intended to reproduce or supply in a permanent manner during its use one or more
known values of a given quantity.

Direct sales

A trading transaction is direct sales if:

> the measurement result serves as the basis for the price to pay and;

> the parties in the transaction must accept the measurement result on the spot and;

> the change of ownership and the payment take place on the spot, or their obligation is established on the spot, as a

result of the acceptance by the parties of the measurement result.

REQUIREMENTS

1.

Allowable errors

1.1.

Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed
the maximum permissible error value as laid down in the appropriate specific instrument requirements.

Unless stated otherwise, maximum permissible error is expressed as a bilateral value of the deviation from the
true measurement value.

Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as
laid down in the appropriate specific instrument requirements.

The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the
instrument is intended to be used, taking account of the requirements for operating conditions laid down in
the appropriate specific instrument requirements.

1.2.

1.3.

1.3.1. Climatic and mechanical environments are differentiated into classes A to I as described below.

C

Climatic environments

C1 This class applies to continuously temperature-controlled enclosed locations. Humidity is not controlled.
Heating, cooling or humidification is used to maintain the required conditions, where necessary. Measuring
instruments may be exposed to solar radiation, heat radiation, and to movements of ambient air due to
they are not subject to condensed water,
drafts from the air-conditioning system or open windows;
precipitation, or ice formations.

The conditions of this class may be found in continuously manned offices, certain workshops, and other
rooms for special applications.

C2 This class applies to enclosed locations whose temperature and humidity are not controlled. Heating may be
used to raise low temperatures, especially in case where there is a large difference between the conditions of
this class and the open air conditions. Measuring instruments may be exposed to solar and heat radiation
and drafts and may be subject to condensed water, water from sources other than rain and to ice
formations.

The conditions of this class may be found in some entrances and staircases of buildings, in garages, cellars,
certain workshops, factory buildings and industrial process plants, ordinary storage rooms for frost-resistant
products, farm buildings, etc.

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C3 This class applies to open locations with average climatic conditions, thus excluding polar and desert

environments.

M Mechanical environments

M1 This class applies to locations with vibration and shocks of low significance, e.g. for instruments fastened to
light supporting structures subject to negligible vibrations and shocks transmitted from local blasting or
pile-driving activities, slamming doors, etc.

M2 This class applies to locations with significant or high levels of vibration and shock, e.g. transmitted from

machines and passing vehicles in the vicinity or adjacent to heavy machines, conveyor belts, etc.

M3 This class applies to locations where the level of vibration and shock is high and very high, e.g. for

instruments mounted directly on machines, conveyor belts, etc.

Table 1

Combined climatic and mechanical environments

Environments

M1

M2

M3

C1

A

D

G

C2

B

E

H

C3

C

F

I

1.3.2. Electromagnetic environments are classified as E1 or E2;

E1 Residential, commercial and light industrial,

E2 Industrial

2.

Reproducibility

The application of the same measurand in a different location or by a different user, all other conditions being
the same, shall result in the close agreement of successive measurements.

3.

Repeatability

3.1.

The application of the same measurand under the same conditions of measurement shall result in close
agreement of successive measurements. The difference between the measurement results shall be small when
compared with the maximum permissible error.

3.2.

For an instrument subject to significant random errors the difference between the mean values of subsequent
series of results shall be small when compared with the maximum permissible error.

4.

Discrimination and sensitivity

A measuring instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low
for the intended measurement task.

5.

Durability

A measuring instrument shall be designed to maintain an adequate stability of its metrological characteristics
over a reasonable period of time provided that it is properly installed, maintained and used according to the
manufacturer’s instruction when in the environmental conditions for which it is intended.

6.

Reliability

A measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an
inaccurate measurement result, unless the presence of such a defect is obvious or can be easily and simply
checked using devices apart from the instrument itself.

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7.

Suitability

7.1.

7.2.

A measuring instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for
unintentional misuse shall be minimal.

A measuring instrument shall be suitable for its intended use taking account of the practical working conditions,
and bearing in mind the intended user, shall not require unreasonable demands of the user in order to obtain a
correct measurement result.

7.3. Where the measurand is the attribute of a product that is conditioned by the measuring instrument, the
the maximum permissible error for the

taking account of

conditioning shall be carried out adequately,
measurement.

7.4. Where a measuring instrument is designed for the measurement of values of the measurand that are constant
over time, the measuring instrument shall be insensitive to small fluctuations of the value of the measurand, or
shall take appropriate action.

7.5.

A measuring instrument shall be robust and its materials of construction shall be suitable for the conditions in
which it is intended to be used.

8.

Protection against corruption

8.1.

8.2.

8.3.

The metrological characteristics of a measuring instrument shall not be inadmissibly influenced by the
connection to it of another device, by any feature of the connected device itself or by any remote device
that communicates with the measuring instrument.

A hardware component that is critical for metrological characteristics shall be designed so that it can be secured.
Security measures foreseen shall provide for evidence of an intervention.

Software that is critical for metrological characteristics shall be identified as such and shall be secured. Its
identification shall be easily available. Evidence of an intervention shall be available for a reasonable period
of time.

8.4.

Measurement data and metrologically important parameters stored or transmitted shall be adequately protected
against accidental or intentional corruption.

8.5.

The displays of utility measuring instruments shall not be able to be reset during use.

9.

Information to be borne by and to accompany the instrument

9.1.

A measuring instrument shall bear the following inscriptions:

> manufacturer’s mark or name,

> information in respect of its accuracy,

plus, when applicable:

> pertinent data in respect of the conditions of use,

> identity marking,

> number of the type examination certificate.

9.2.

9.3.

An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant
information shall have its accompanying container and/or associated documentation suitably marked.

A measuring instrument shall be accompanied by information on its operation. Information should include
where relevant:

> rated operating conditions;

> climatic, mechanical and electromagnetic environment classes;

> instruction for installation, maintenance, repairs, permissible adjustments;

> instruction for correct operation and any special conditions of use.

9.4.

Instruments used for utility measurements or groups of instruments do not necessarily require individual
instruction manuals.

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9.5.

Unless specified otherwise in a specific instrument annex the scale interval for a measured value shall be in the
form 1 H 10n, 2 H 10n, or 5 H 10n, where n is any integer or zero. The unit of measurement or its symbol shall
be shown close to the numerical value.

9.6.

A material measure shall be marked with a nominal value or a scale, accompanied by the unit of measurement.

9.7.

9.8.

The units of measurement used and their symbols shall be in accordance with the legal provisions at Community
level on units of measurement and their symbols.

All marks and inscriptions required under any requirement shall be clear, indelible, unambiguous and non-trans-
ferable.

10.

Indication of result

10.1.

Indication of the result shall be by means of a display or hard copy.

10.2.

The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions
necessary to inform the user of the significance of the result. Easy reading of the presented result shall be
permitted under normal conditions of use. Additional
indications may be shown provided they cannot be
confused.

10.3.

In the case of hard copy the print or record shall also be easily legible and indelible.

10.4. A measuring instrument for direct sales trading transactions shall be designed to present the measurement result

to both parties in the transaction when installed as intended.

10.5. A measuring instrument intended for domestic utility measurement purposes from which the measurement data
can be read either by a mobile data capture unit or remotely via a transmission link shall be fitted with a display
accessible to the consumer. The reading of this display is the measurement result that serves as the basis for the
price to pay.

11.

Further processing of data to conclude the trading transaction

11.1. A measuring instrument other than a utility measuring instrument shall record by a durable means the

measurement result accompanied by information to identify the particular transaction, when;

> the measuring instrument is for direct sales trading transactions and;

> the measurement is non-repeatable and;

> the measuring instrument is normally for use in the absence of one of the trading parties.

11.2. Additionally, a durable proof of the measurement result and the information to identify the transaction shall be

available on request at the time the measurement is concluded.

12.

Conformity evaluation

A measuring instrument shall be designed so as to allow ready evaluation of
requirements of this directive.

its conformity with the

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Official Journal of the European Communities

27.2.2001

ANNEX II

TEST PROGRAMMES

INTRODUCTION

Appropriate results obtained having carried out the test programmes are deemed to satisfy the particular aspect of the
product requirement under evaluation. In the case of a particular instrument, values attributed in the test programmes
to severity levels or combinations of severity levels for the climatic and mechanical classes A-I may be changed by direct
reference in the specific annex.

Test set-ups and test procedures shall be according to internationally agreed documents.

1.

TEST PROGRAMMES

Test programmes are separated according to operating conditions as follows:

Programme 1: Electromagnetic environment

Programme 2: Climatic environment

Programme 3: Mechanical environment

Programme 4: Power supply

A further test programme, programme 5 concerns durability.

1.1.

Applicability of test programmes

An instrument or sub-assembly is subjected to test according to its rated operating conditions which shall be
in accordance with the requirements of the specific instrument annex.

1.2.1.

Climatic and mechanical classes

The climatic and mechanical classes, A-I, are as outlined in Table 1 of Annex I.

The appropriate severity levels for testing are as set out below.

Table 1

Severity levels

A

1

1

>

>

>

>

B

2

2

1

1

>

>

C

3

3

2

2

>

>

D

1

1

>

>

1

1

Classes

E

2

2

1

1

1

1

F

3

3

2

2

1

1

G

1

1

>

>

2

2

H

2

2

1

1

2

2

I

3

3

2

2

2

2

Description of test

Heat

Dry cold

Damp heat, steady state

Damp heat, cyclic

Vibration

Mechanical shock

1.2.2.

Electromagnetic Environmental Classes

Class E1> Residential, commercial and light industry environment

Class E2 > Industrial environment

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1.3.

Basic rules concerning the determination of errors

Errors shall be determined under normal test conditions. When the effect of one influence quantity is being
evaluated, all other factors are to be kept relatively constant, at a value close to normal.

1.4.

Basic rules for testing

Each influence quantity is applied and its effect evaluated separately. Metrological test shall be carried out
during or after the application of the influence quantity whichever condition corresponds to the normal
operational status of the instrument when that influence quantity is likely to occur.

2.

PROGRAMME 1: ELECTROMAGNETIC ENVIRONMENT

The test programme as outlined in Tables 2, 3 and 4 apply to the instrument or sub-assembly according to
the electromagnetic environment, E1 or E2, in which the instrument is intended to be used.

Where the instrument or sub-assembly is intended to be used in a permanent continuous electromagnetic
field the permitted performance during the radiated electromagnetic field > amplitude modulated test shall
be within maximum permissible error, in all other cases the critical change value and the permissible effect is
that laid down in the specific instrument Annex.

Table 2

Disturbance

Port

E1

E2

Voltage interruptions on AC
supply

Input ports

Voltage dips on AC supply

Input ports

Electrostatic discharge

Enclosure port

Fast transients (1)

> Ports for signal

lines and
data buses not involved in
process control;

> Ports directly involved in
in process
process,
and
measurement,
signalling
and control;

> 95 % reduction over 5 000 ms

30 % reduction over 10 ms
60 % reduction over 100 ms

4 kV Contact
8 kV Air

– 500 V (2)

1 000 V

– 500 V (2)

– 2 000 V

> I/O DC power ports;

– 500 V (3)

– 2 000 V

> I/O AC power ports;

– 1 000 V

– 2 000 V

> Functional earth ports.

– 500 V (2)

– 1 000 V

Radio frequency electromagnetic
field
Amplitude modulated

Enclosure port

Radio frequency electromagnetic
field
Keyed carrier

Enclosure port

80-1 000 MHz
3 V/m
80 % MA
(1 kHz)

80-1 000 MHz (4)
10 V/m
80 % MA
(1 kHz)

900 – 5 MHz
3 V/m
50 Duty cycle %
200 Rep. frequency
Hz

900 – 5 MHz
10 V/m
50 Duty cycle %
200 Rep. frequency
Hz

(1) 5 Tr/50 Th ns, 5 rep. Frequency kHz in all cases.
(2) Applicable only to ports interfacing with cables whose total length according to the manufacturer’s functional specifi-

cation may exceed 3 m.

(3) Not applicable to input ports intended for connection to a battery or a rechargeable battery which must be removed or
disconnected from the apparatus for recharging. Apparatus with a DC power input port intended for use with an AC-DC
power adapter shall be tested on the AC power input of the AC-DC power adapter specified by the manufacturer or
where none is so specified using a typical AC-DC power adapter. The test is applicable to DC power input ports intended
to be connected permanently to cables longer than 10 m.

(4) Except for ITU broadcast frequency bands 87 MHz-108 MHz, 174 MHz-230 MHz, and 470 MHz-790 MHz where the

level shall be 3 V.

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Table 3

Radio frequency 5 common code

Port

E1

E2

> Ports for signal

lines and data
buses not involved in process
control,

0,15-80 Mhz (1)
3 V
80 % MA (1 kHz)

0,15-80 MHz (1) (2)
10 V
80 % MA (1 kHz)

> Ports

directly
and

process,
measurement
control

involved
in
signalling

in
process
and

> I/O DC power ports

> I/O AC power ports,
> Functional earth ports

0,15-80 MHz (1)
3 V
80 % MA (1 kHz)

0,15-80 MHz
3 V
80 % MA (1 kHz)

0,15-80 MHz (2)
10 V
80 % MA (1 kHz)

0,15-80 MHz (2)
3 V
80 % MA (1 kHz)

The test level can be defined as the equivalent current into a 150 ohm load.

(1) Applicable only to ports interfacing with cables whose total length according to the manufacturer’s functional specifi-

cation may exceed 3 m.

(2) Except for ITU broadcast frequency bands 47 MHz-68 MHz where the level shall be 3 V.

Port

Ports for signal lines and data buses
not involved in process control

Ports directly involved in process,
and
process measurement,
signalling and control

in

DC input ports

AC input ports

Table 4

Surges

E1

>

>

E2

1,2 Tr/50 Th ms (8/20) (2)
line to ground – 2 kV
line to line – 1 kV

1,2 Tr/50 Th ms (8/20)
line to ground – 2 kV
line to line – 1 kV

1,2 Tr/50 Th (cid:1)s (8/20) (1) (3)
line to ground – 0,5 kV
line to line – 0,5 kV

1,2 Tr/50 Th ms (8/20)
line to ground – 0,5 kV
line to line – 0,5 kV

1,2 Tr/50 Th (cid:1)s (8/20)
line to ground – 2 kV
line to line – 1 kV

1,2 Tr/50 Th ms (8/20)
line to ground – 4 kV
line to line – 2 kV

(1) Apparatus with a DC power input port intended for use with an AC-DC power adapter shall be tested on the AC power
input of the AC-DC power adapter specified by the manufacturer or where none is so specified using a typical AC-DC
power adapter. The test is applicable to DC power input ports intended to be connected permanently to cables longer
than 10 m.

(2) Applicable only to ports interfacing with cables whose total length according to the manufacturer’s functional specifi-

cation may exceed 10 m.

(3) Not applicable to input ports intended for connection to a battery or to a rechargeable battery which must be removed

or disconnected from the apparatus for recharging.

3.

PROGRAMME 2: CLIMATIC ENVIRONMENT

To verify operation within maximum permissible error under the relevant climatic environment conditions

3.1.

Static temperature

Where practicable both dry heat and cold tests may be combined in a cycle.

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3.1.1.

Dry heat

To verify operation within maximum permissible error under conditions of high temperature.

Severity level

Temperature (MC)

Duration (h)

3.1.2.

Cold

1

30

2

2

40

2

To verify performance within maximum permissible error under conditions of low temperature

Severity level

Temperature (MC)

Duration (h)

1

+ 5

2

2

O 10

2

3

55

2

3

O 25

2

3.2.

Ambient humidity

According to the climatic operating environment in which the instrument is intended to be used either the
damp heat steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate.

The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will
be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp
heat steady state is appropriate.

3.2.1.

Damp heat, steady-state (non-condensing)

To verify operation within maximum permissible error under conditions of high humidity and constant
temperature.

Severity level

Temperature (MC)

Relative humidity (%)

Duration (days)

1

30

85

2

2

40

93

4

3.2.2.

Damp heat, cyclic (condensing)

To verify operation within maximum permissible error under conditions of high humidity when combined
with cyclic temperature changes.

Severity level

Temperature range (MC)

Duration (cycles)

Relative humidity

1

25-40

2

2

25-55

2

95 % at lower temperature phases
and 93 % at upper temperature
phases

95 % at lower temperature phases
and 93 % at upper temperature
phases

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Official Journal of the European Communities

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4.

PROGRAMME 3: MECHANICAL ENVIRONMENT

To verify operation within maximum permissible error under
conditions

the relevant mechanical environment

4.1.

Vibration

The random vibration test is appropriate for evaluation of conditions where the magnitude of the influence
quantity is not stable. The test for sinusoidal vibration is appropraite for evaluation of conditions where the
frequenc(y)(ies) and the level(s) of effective acceleration are known and stable, or when a relevant resonance
frequency is known.

4.1.1.

Random vibration

To verify operation within maximum permissible error under conditions of random vibration.

Severity level

Total frequency range (Hz)

Total RMS level (m.sO2)

ASD level 10-20 Hz (m2.sO3)

ASD level 20-150 Hz (dB/octave)

Number of axes

Duration per axis

1

10-15

1,6

0,048

O 3

3

2

10-150

7

1

O 3

3

Two minutes in each functional mode or a
longer period if necessary for carrying out
the measurement

4.1.2.

Sinsuidol vibration

To verify operation within maximum permissible error under conditions of vibration of a consistent
character.

Severity level

Frequency range (Hz)

Max. acceleration level (m.sO2)

Number of sweep cycles per axis

1

2

10-150

10-150

2

20

4.2.

Mechanical shock

To verify operation within maximum permissible error under conditions of mechanical shock

Severity level

Height of fall (mm)

Number of falls (on each bottom edge)

1

25

1

10

20

2

50

1

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5.

PROGRAMME 4: POWER SUPPLY

To verify operation within maximum permissible error under normal power supply conditions.

Characteristic

Test specification

Mains voltage variation

85-110 % nominal

DC voltage variation

to the limits as specified by the manufacturer

Mains frequency variation

98-102 % nominal

6.

PROGRAMME 5: DURABILITY

To assess the possible occurrence of defects over the expected lifetime of the instrument or sub-assembly.

6.1.

Gas meters

6.1.1.

Diaphragm meters

6.1.1.1.

Test specification: 5 000 hours at Qmax

6.1.1.2.

Allowable errors

During and after test at flow rates of Qmin, 2 Qmin, 0,1 Qmax, 0,4 Qmax, 0,7 Qmax and Qmax:

> the error of indication at each flow rate in the range Qt to Qmax shall not differ from the corresponding

initial value by more the 2 % for that flow rate,

> the error of indication shall be within twice the maximum permissible error.

6.1.2.

Rotary positive displacement and turbine meters

6.1.2.1.

Test specification: 1 000 hours, total duration shall not last more than two months.

6.1.2.2.

Allowable errors

After test at flow rates of Qmin, 0,05 Qmax, 0,15 Qmax, 0,25 Qmax, 0,4 Qmax, 0,7 Qmax and Qmax:

> the error of indication at each test flow rate shall not differ from the corresponding initial value by more

than one third of the maximum permissible error for that flow rate,

> the error of indication shall be within the maximum permissible error.

6.2.

Water meters

6.2.1.

Water meters shall be submitted to two consecutive series of tests

> Q3 less than or equal to 16 m3/h

> First series (Cyclic test): 100 000 discontinuous cycles during which the flow-rate may vary between
zero and Q3. Each cycle shall include at least one period during which the flow-rate must be zero
and at least one period during which the flow-rate must be Q3.

> Second series (Continuous test): continuous flow at Q4 during 100 hours.

> Q3 greater than 16 m3/h

> First series: Continuous flow at Q3 during 750 hours

> Second series: Continuous flow at Q4 during 200 hours.

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6.2.2.

Allowable errors

6.2.2.1.

Variation on measurement error after each series of tests when compared to initial measurement error shall
not exceed:

> 3 % of the metered volume between Q1 included and Q2 excluded,

> 1,5 % of the metered volume between Q2 included and Q4 included.

6.2.2.2. Measurement error on volume metered after each series of tests shall not exceed:

> – 6 % of the metered volume between Q1 included and Q2 excluded,

> – 2,5 % of the metered volume between Q2 included and Q4 included for water meters intended to meter

water with a temperature between 0,1 MC and 30 MC,

> – 3,5 % of the metered volume between Q2 included and Q4 included for water meters intended to meter

water with a temperature between 30 MC and 90 MC.

6.2.3.

Volume of water

The volume of water passed through each tested meter and due to the two series of tests as defined in 2.1
must be at least:

600 H Q3 (in m3) for Q3 < 16 m3/h

1 000 H Q3 (in m3) for Q3 > 16 m3/h.

6.2.4.

Tested flow rates

Measurement errors on volume of water must be determined at reference conditions before and after each
series of tests, for each tested meter and at least for the following flow rates:

Q1 - (Q1 + Q2)/2 - Q2 - 0,1Q3 - 0,3Q3 - 0,5Q3 - Q3 - Q4.

6.2.5.

Test conditions

Tests shall be carried out with water of an appropriate temperature to test the meter for the temperature
range for which it is intended. Water used in testing shall be clean water having no solid particles in
suspension, a low agressivity and a low proportion of calcium carbonate.

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CRITERIA TO BE SATISFIED BY BODIES DESIGNATED BY THE MEMBER STATES FOR THE CARRYING
OUT OF TASKS PERTAINING TO THE CONFORMITY ASSESSMENT MODULES

ANNEX III

Set out below are the criteria that Member States shall apply for the designation of bodies according to Article 8,
paragraph 1.

1. The body, its director and the staff involved in conformity assessment work shall not be the designer, manufacturer,
supplier, installer or user of the measuring instruments that they inspect, nor the authorised representative of any of
these persons. Also they may not be directly involved in the design, manufacture, marketing or maintenance of the
instruments, nor represent the parties engaged in these activities. The preceding criteria do not, however, preclude in
any way the possibility of exchanges of technical information for purposes of conformity assessment, between the
manufacturer and the body.

2. The body and its staff involved in conformity assessment work shall be free from all pressures and inducements, in
particular financial inducements, that might influence their judgement or the results of their conformity assessment
work, especially from persons or groups of persons with an interest in the results of the assessments.

3. The conformity assessment tasks shall be carried out with the highest degree of professional integrity and requisite

competence in the field of metrology.

Should the body subcontract specific tasks connected with the establishment or verification of product performance
or specifications, it shall first ensure that the subcontractor meets the provisions of this Directive, and in particular of
this Annex. The body shall keep the relevant documents assessing the subcontractor’s qualifications and the work
carried out by him under this Directive at the disposal of the national authorities.

4. The body shall be able to carry out all the tasks assigned to such bodies by the Annex for which it has been notified,
whether these tasks are carried out by the body itself or on its behalf and under its responsibility. It shall dispose in
particular of the necessary staff and possess the necessary facilities for carrying out the technical and administrative
tasks entailed in assessment and verification in a proper manner. It shall also have access to the equipment necessary
for the required verification.

5. The body shall have

> sound vocational training, covering all assessment and verification operations for which the body was designated;

> satisfactory knowledge of the rules in respect of the inspections which it carries out, and adequate experience of

such inspections;

> the ability required to draw up the certificates, records and reports to demonstrate that the inspections were

carried out.

6. The impartiality of the body must be guaranteed. Its remuneration must not depend on the number of inspections

carried out, nor on the results of the inspections.

7. The body must have taken out civil liability insurance, unless liability is assumed by the Member State under national

legislation or the Member State carries out the inspections itself directly.

8. The body’s staff are bound to observe professional secrecy with regard to all information obtained in the course of
exercising their duties pursuant to this Directive or any provision of national law putting this Directive into effect,
except vis-Q-vis the competent administrative authorities of the Member State in which their activities are carried out.

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Official Journal of the European Communities

27.2.2001

ANNEX IV

TECHNICAL DOCUMENTATION

The technical documentation shall render the design, manufacture and operation of the measuring instrument intel-
ligible and shall enable assessment of its conformity with the appropriate requirements of this Directive.

The documentation shall include in so far as relevant for assessment:

> a general description of the instrument;

> conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.;

> descriptions and explanations necessary for the understanding of

the above,

including the operation of

the

instrument;

> a list of the standards referred to in Article 9, applied in full or in part, and descriptions of the solutions adopted to

meet the essential requirements where the standards referred to in Article 9 have not been applied;

> results of design calculations, examinations, etc.;

> test reports;

> the EC type examination certificates or EC design examination certificates in respect of instruments containing parts

identical to those in the design.

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C 62 E/21

DECLARATION OF CONFORMITY BASED ON INTERNAL PRODUCTION CONTROL

ANNEX A

1.

The declaration of conformity based on internal production control is the conformity assessment procedure
whereby the manufacturer or his authorised representative fulfils the obligations laid down hereafter, and ensures
and declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive.

Technical documentation

2.

3.

The manufacturer shall establish the technical documentation as described in Annex IV. The documentation shall
enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It
shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of the national authorities for a period
ending ten years after the last instrument has been manufactured.

Manufacturing

4.

The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with
the appropriate requirements of this Directive.

Written declaration of conformity

5.1.

5.2.

The manufacturer shall affix the CE conformity marking and the supplementary metrology marking to each
measuring instrument that satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument of that model has been manufactured.
It shall identify the model of the instrument for which it was drawn up.

A copy of the declaration shall also be sent to one of the bodies notified for type examination according to
Article 8 whose responsibility it shall be to periodically make the list of declarations of conformity received
available to all Member States.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

Authorised representative

6.

The manufacturer’s obligations contained in paragraphs 3 and 5.2 may be fulfilled, on his behalf and under his
responsibility, by his authorised representative established within the Community.

Where neither the manufacturer nor his authorised representative is established within the Community, the
obligations mentioned above shall be the responsibility of the importer or any other person who places the
instrument on the Community market.

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DECLARATION OF CONFORMITY BASED ON INTERNAL PRODUCTION CONTROL PLUS PRODUCT
TESTING BY A NOTIFIED BODY

ANNEX A1

1.

The declaration of conformity based on internal production control plus product testing by a notified body is the
conformity assessment procedure whereby the manufacturer or his authorised representative fulfils the obli-
gations laid down hereafter, and ensures and declares that the measuring instruments concerned satisfy the
appropriate requirements of this Directive.

Technical documentation

2.

3.

The manufacturer shall establish the technical documentation as described in Annex IV. The documentation shall
enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It
shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of the national authorities for a period
ending ten years after the last instrument has been manufactured.

Manufacturing

4.

The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with
the appropriate requirements of this Directive.

Product checks

5.

A notified body chosen by the manufacturer shall carry out product checks at random intervals, or have them
carried out. An adequate sample of the final products, taken by the notified body before the placing on the
market, shall be examined and appropriate tests as identified by the relevant document(s) referred to in Article 9,
or equivalent tests, shall be carried out to check the conformity of the instruments with the appropriate
requirements of this Directive.
In the absence of a relevant document, the notified body concerned shall
decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not conform the notified body shall take
appropriate measures.

Written declaration of conformity

6.1.

6.2.

The manufacturer shall affix the CE conformity marking, the supplementary metrology marking and, under the
responsibility of
the latter’s identification number to each
the notified body referred to in paragraph 5,
measuring instrument that satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall also be sent to one of the bodies notified for type examination according to
Article 8 whose responsibility it shall be to periodically make the list of declarations of conformity received
available to all Member States.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

Authorised representative

7.

The manufacturer’s obligations contained in paragraphs 3 and 6.2 may be fulfilled, on his behalf and under his
responsibility, by his authorised representative established within the Community.

Where neither the manufacturer nor his authorised representative is established within the Community, the
obligations mentioned above shall be the responsibility of the importer or any other person who places the
instrument on the Community market.

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C 62 E/23

ANNEX B

Type examination

1.

2.

Type examination is the part of a conformity assessment procedure whereby a notified body examines the
technical design of a measuring instrument and ascertains and attests that the technical design meets the
provisions of this Directive that apply to the measuring instrument.

Type examination may be carried out in either of the following manners. The notified body decides on the
appropriate manner and the specimens required.

(a) examination of a specimen, representative of

the production envisaged, of

the complete measuring

instrument;

(b) examination of specimens, representative of the production envisaged, of one or more critical parts of the
measuring instrument, plus assessment of the adequacy of the technical design of the other parts of the
measuring instrument through examination of the technical documentation and supporting evidence referred
to in paragraph 3;

(c) assessment of the adequacy of the technical design of the measuring instrument through examination of the
technical documentation and supporting evidence referred to in paragraph 3, without examination of a
specimen.

3.

The application for type examination shall be lodged by the manufacturer or his authorised representative
established within the Community with a notified body of his choice.

The application shall include:

> the name and address of the manufacturer and, if the application is lodged by the authorised representative,

his name and address in addition;

> a written declaration that the same application has not been lodged with any other notified body;

> the technical documentation as described in Annex IV. The documentation shall enable assessment of the
conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant
for such assessment, cover the design, manufacture and operation of the instrument;

> the specimens, representative of the production envisaged, as required by the notified body;

> the supporting evidence for the adequacy of the technical design of those parts of the measuring instrument
for which no specimens are required. This supporting evidence shall mention any relevant documents that
have been applied, in particular where the relevant documents referred to in Article 9 have not been applied
in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the
manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4.

The notified body shall:

For the specimens:

4.1.

4.2.

4.3.

examine the technical documentation, verify that the specimens have been manufactured in conformity with it
and identify the elements which have been designed in accordance with the relevant provisions of the relevant
documents referred to in Article 9, as well as the elements which have been designed without applying the
relevant provisions of those documents;

carry out the appropriate examinations and tests, or have them carried out, to check whether, where the
manufacturer has chosen to apply the solutions in the relevant documents, these have been applied correctly;

carry out the appropriate examinations and tests, or have them carried out, to check whether, where the
manufacturer has chosen not to apply the solutions in the relevant documents, the solutions adopted by the
manufacturer meet the corresponding essential requirements of this Directive;

4.4.

agree with the applicant on the location where the examinations and tests shall be carried out.

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For the other parts of the measuring instrument:

4.5.

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of
the other parts of the measuring instrument.

For the manufacturing process:

4.6.

5.

examine the technical documentation to assure that the manufacturer has adequate means to ensure consistent
production.

Where the technical design meets the provisions of this Directive that apply to the measuring instrument, the
notified body shall issue an EC type examination certificate to the applicant. The certificate shall contain the
name and address of the manufacturer, conclusions of the examination, conditions (if any) for its validity and the
necessary data for identification of the instrument.

All relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the
notified body.

The certificate shall have a validity period of ten years from the date of its issue, and may be renewed for
subsequent periods of ten years each.

6.

The applicant shall inform the notified body that holds the technical documentation concerning the EC type
examination certificate of all modifications to the instrument that may affect the conformity of the instrument
with the essential requirements or the conditions for validity of the certificate. Such modifications require
additional approval in the form of an addition to the original EC type examination certificate.

7.

Each notified body shall periodically make available to all Member States the list of:

> EC type examination certificates issued;

> EC type examination certificates refused;

> additions and amendments relating to certificates already issued.

Each notified body shall inform all Member States immediately of the withdrawal of an EC type examination
certificate. Each Member State shall make this information available to the bodies that it has notified.

8.

9.

The other notified bodies may receive a copy of the EC type examination certificates and/or their additions. The
annexes to the certificates shall be kept at the disposal of the other notified bodies.

The manufacturer or his authorised representative established within the Community shall keep a copy of the EC
type examination certificate and its additions with the technical documentation for a period ending 10 years after
the last measuring instrument has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the
obligation to keep the technical documentation available shall be the responsibility of the importer or any other
person who places the measuring instrument on the Community market.

27.2.2001

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Official Journal of the European Communities

C 62 E/25

DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL

ANNEX C

1.

is the part of a conformity
The declaration of conformity to type based on internal production control
assessment procedure whereby the manufacturer or his authorised representative fulfils the obligations laid
down hereafter and ensures and declares that the measuring instruments concerned are in conformity with
the type as described in the EC type examination certificate and satisfy the appropriate requirements of this
Directive.

Manufacturing

2.

The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with
the type as described in the EC type examination certificate and with the appropriate requirements of this
Directive.

Written declaration of conformity

3.1.

3.2.

The manufacturer shall affix the CE conformity marking and the supplementary metrology marking to each
measuring instrument that is in conformity with the type as described in the EC type examination certificate and
satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

Authorised representative

4.

The manufacturer’s obligations contained in paragraph 3.2 may be fulfilled, on his behalf and under his
responsibility, by his authorised representative established within the Community.

Where neither the manufacturer nor his authorised representative is established within the Community, the
obligations mentioned above shall be the responsibility of the importer or any other person who places the
instrument on the Community market.

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DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS
PRODUCT TESTING BY A NOTIFIED BODY

ANNEX C1

1.

The declaration of conformity to type based on internal production control plus product testing by a notified
body is the part of a conformity assessment procedure whereby the manufacturer or his authorised represen-
tative fulfils the obligations laid down hereafter and ensures and declares that the measuring instruments
concerned are in conformity with the type as described in the EC type examination certificate and satisfy the
appropriate requirements of this Directive.

Manufacturing

2.

The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with
the type as described in the EC type examination certificate and with the appropriate requirements of this
Directive.

Product checks

3.

A notified body chosen by the manufacturer shall carry out product checks at random intervals, or have them
carried out. An adequate sample of the final products, taken by the notified body before the placing on the
market, shall be examined and appropriate tests as identified by the relevant document(s) referred to in Article 9,
or equivalent tests, shall be carried out to check the conformity of the product with the type as described in the
EC type examination certificate and the appropriate requirements of the Directive. In the absence of a relevant
document, the notified body concerned shall decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not conform the notified body shall take
appropriate measures.

Written declaration of conformity

4.1.

4.2.

The manufacturer shall affix the CE conformity marking, the supplementary metrology marking and, under the
responsibility of the notified body referred to in paragraph 3 the latter’s identification number, to each measuring
instrument that is in conformity with the type as described in the EC type examination certificate and satisfies
the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

Authorised representative

5.

The manufacturer’s obligations contained in paragraph 4.2 may be fulfilled, on his behalf and under his
responsibility, by his authorised representative established within the Community.

Where neither the manufacturer nor his authorised representative is established within the Community, the
obligations mentioned above shall be the responsibility of the importer or any other person who places the
instrument on the Community market.

27.2.2001

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Official Journal of the European Communities

C 62 E/27

DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION
PROCESS

ANNEX D

1.

The declaration of conformity to type based on quality assurance of the production process is the part of a
conformity assessment procedure whereby the manufacturer fulfills the obligations laid down hereafter and
ensures and declares that the measuring instruments concerned are in conformity with the type as described
in the EC type examination certificate and satisfy the appropriate requirements of this Directive.

Manufacturing

2.

The manufacturer shall operate an approved quality system for production, final product inspection and testing
of the measuring instrument concerned as specified in paragraph 3 and shall be subject to surveillance as
specified in paragraph 4.

Quality system

3.1.

The manufacturer shall lodge an application for assessment of the quality system with a notified body of his
choice.

The application shall include:

> all relevant information for the instrument category envisaged;

> the documentation concerning the quality system;

> the technical documentation of the approved type and a copy of the EC type examination certificate.

3.2.

The quality system shall ensure compliance of the instruments with the type as described in the EC type
examination certificate and the appropriate requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic
and orderly manner in the form of written policies, procedures and instructions. This quality system documen-
tation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

> the quality objectives and the organizational structure, responsibilities and powers of the management with

regard to product quality;

> the manufacturing, quality control and quality assurance techniques, processes and systematic actions that

will be used;

> the examinations and tests that will be carried out before, during, and after manufacture, and the frequency

with which they will be carried out;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc;

> the means to monitor the achievement of the required product quality and the effective operation of the

quality system.

3.3.

The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in
paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies
with the corresponding specifications of
implements the relevant harmonised
standard.

the national standard that

The auditing team shall include persons with experience in the instrument technology concerned and experience
as a legal metrology assessor. The evaluation procedure shall include an inspection visit to the manufacturer’s
premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of
examination and the reasoned assessment decision.

the

3.4.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.

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3.5.

The manufacturer shall keep the notified body that has approved the quality system informed of any intended
updating of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality system will
still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination
and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

4.1.

4.2.

4.3.

4.4.

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture,
inspection, testing and storage, and shall provide it with all necessary information, in particular:

> the quality system documentation;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the
quality system and shall provide an audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified
body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is
functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out,
with a test report.

Written declaration of conformity

5.1.

5.2.

The manufacturer shall affix the CE conformity marking, the supplementary metrology marking and, under the
responsibility of the notified body referred to in paragraph 3.1, the latter’s identification number to each
measuring instrument that is in conformity with the type as described in the EC type examination certificate
and satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

6.

The manufacturer shall, for a period ending ten years after the last instrument has been manufactured, keep at
the disposal of the national authorities:

> the documentation referred to in paragraph 3.1, second indent;

> the updating referred to in paragraph 3.5, as approved;

> the decisions and reports from the notified body referred to in paragraphs 3.5, 4.3 and 4.4.

7.

Each notified body shall periodically make available to all Member States the list of quality system approvals
issued or refused, and shall
immediately inform all Member States of the withdrawal of a quality system
approval.

Each Member State shall make this information available to the bodies which it has notified.

Authorised representative

8.

The manufacturer’s obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and
under his responsibility, by his authorised representative established within the Community.

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Official Journal of the European Communities

C 62 E/29

DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

ANNEX D1

1.

The declaration of conformity based on quality assurance of the production process is the conformity assessment
procedure whereby the manufacturer fulfills the obligations laid down hereafter and ensures and declares that the
measuring instruments concerned satisfy the appropriate requirements of this Directive.

Technical documentation

2.

3.

The manufacturer shall establish the technical documentation as described in Annex IV. The documentation shall
enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It
shall, as far as relevant for such assessment, cover the design and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of the national authorities for a period
ending ten years after the last instrument has been manufactured.

Manufacturing

4.

The manufacturer shall operate an approved quality system for production, final product inspection and testing
of the measuring instrument concerned as specified in paragraph 5 and shall be subject to surveillance as
specified in paragraph 6.

Quality system

5.1.

The manufacturer shall lodge an application for assessment of the quality system with a notified body of his
choice.

The application shall include:

> all relevant information for the instrument category envisaged;

> the documentation concerning the quality system;

> the technical documentation referred to in paragraph 2.

5.2.

The quality system shall ensure compliance of the instruments with the appropriate requirements of this
Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic
and orderly manner in the form of written policies, procedures and instructions. This quality system documen-
tation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

> the quality objectives and the organizational structure, responsibilities and powers of the management with

regard to product quality;

> the manufacturing, quality control and quality assurance techniques, processes and systematic actions that

will be used;

> the examinations and tests that will be carried out before, during, and after manufacture, and the frequency

with which they will be carried out;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc;

> the means to monitor the achievement of the required product quality and the effective operation of the

quality system.

5.3.

The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in
paragraph 5.2. It shall presume conformity with these requirements in respect of a quality system that complies
with the corresponding specifications of
implements the relevant harmonised
standard.

the national standard that

The auditing team shall include persons with experience in the instrument technology concerned and experience
as a legal metrology assessor. The evaluation procedure shall include an inspection visit to the manufacturer’s
premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of
examination and the reasoned assessment decision.

the

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5.4.

5.5.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.

The manufacturer shall keep the notified body that has approved the quality system informed of any intended
updating of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality system will
still satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination
and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

6.1.

6.2.

6.3.

6.4.

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture,
inspection, testing and storage, and shall provide it with all necessary information, in particular:

> the quality system documentation;

> the technical documentation referred to in paragraph 2;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the
quality system and shall provide an audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified
body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is
functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out,
with a test report.

Written declaration of conformity

7.1.

7.2.

The manufacturer shall affix the CE conformity marking, the supplementary metrology marking and, under the
responsibility of the notified body referred to in paragraph 5.1, the latter’s identification number to each
measuring instrument that satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

8.

The manufacturer shall, for a period ending ten years after the last instrument has been manufactured, keep at
the disposal of the national authorities:

> the documentation referred to in paragraph 5.1, second indent;

> the updating referred to in paragraph 5.5, as approved;

> the decisions and reports from the notified body referred to in paragraphs 5.5, 6.3 and 6.4.

9.

Each notified body shall periodically make available to all Member States the list of quality system approvals
issued or refused, and shall
immediately inform all Member States of the withdrawal of a quality system
approval.

Each Member State shall make this information available to the bodies which it has notified.

Authorised representative

The manufacturer’s obligations contained in paragraphs 5.1, 5.5, 7.2 and 8 may be fulfilled, on his behalf and

10.
under his responsibility, by his authorised representative established within the Community.

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C 62 E/31

DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF FINAL PRODUCT
INSPECTION AND TESTING

ANNEX E

1.

The declaration of conformity to type based on quality assurance of final product inspection and testing is the
part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down hereafter
and ensures and declares that the measuring instruments concerned are in conformity with the type as described
in the EC type examination certificate and satisfy the appropriate requirements of this Directive.

Manufacturing

2.

The manufacturer shall operate an approved quality system for final product inspection and testing of the
measuring instrument concerned as specified in paragraph 3 and shall be subject to surveillance as specified
in paragraph 4.

Quality system

3.1.

The manufacturer shall lodge an application for assessment of the quality system with a notified body of his
choice.

The application shall include:

> all relevant information for the instrument category envisaged;

> the documentation concerning the quality system;

> the technical documentation of the approved type and a copy of the EC type examination certificate.

3.2.

The quality system shall ensure compliance of the instruments with the type as described in the EC type
examination certificate and the appropriate requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic
and orderly manner in the form of written policies, procedures and instructions. This quality system documen-
tation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

> the quality objectives and the organizational structure, responsibilities and powers of the management with

regard to product quality;

> the examinations and tests that will be carried out after manufacture;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc;

> the means to monitor the effective operation of the quality system.

3.3.

The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in
paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies
with the corresponding specifications of
implements the relevant harmonised
standard.

the national standard that

The auditing team shall include persons with experience in the instrument technology concerned and experience
as a legal metrology assessor. The evaluation procedure shall include an inspection visit to the manufacturer’s
premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of
examination and the reasoned assessment decision.

the

3.4.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.

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3.5.

The manufacturer shall keep the notified body that has approved the quality system informed of any intended
updating of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality system will
still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination
and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

4.1.

4.2.

4.3.

4.4.

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes to the locations of inspection,
testing and storage, and shall provide it with all necessary information, in particular:

> the quality system documentation;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the
quality system and shall provide an audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified
body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is
functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out,
with a test report.

Written declaration of conformity

5.1.

5.2.

The manufacturer shall affix the CE conformity marking, the supplementary metrology marking and, under the
responsibility of the notified body referred to in paragraph 3.1, the latter’s identification number to each
measuring instrument that is in conformity with the type as described in the EC type examination certificate
and satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

6.

The manufacturer shall, for a period ending ten years after the last instrument has been manufactured, keep at
the disposal of the national authorities:

> the documentation referred to in the second indent of paragraph 3.1;

> the updating referred to in the second paragraph of paragraph 3.5, as approved;

> the decisions and reports from the notified body which are referred to in the final paragraph of paragraph

3.5, paragraph 4.3 and paragraph 4.4.

7.

Each notified body shall periodically make available to all Member States the list of quality system approvals
issued or refused, and shall
immediately inform all Member States of the withdrawal of a quality system
approval.

Each Member State shall make this information available to the bodies which it has notified.

Authorised representative

8.

The manufacturer’s obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and
under his responsibility, by his authorised representative established within the Community.

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Official Journal of the European Communities

C 62 E/33

DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF FINAL PRODUCT INSPECTION
AND TESTING

ANNEX E1

1.

The declaration of conformity based on quality assurance of
inspection and testing is the
conformity assessment procedure whereby the manufacturer fulfils the obligations laid down hereafter and
ensures and declares that
the measuring instruments concerned are in conformity with the appropriate
requirements of this Directive.

final product

Technical documentation

2.

3.

The manufacturer shall establish the technical documentation as described in Annex IV. The documentation shall
enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It
shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of the national authorities for a period
ending ten years after the last instrument has been manufactured.

Manufacturing

4.

The manufacturer shall operate an approved quality system for final product inspection and testing of the
measuring instrument concerned as specified in paragraph 5 and shall be subject to surveillance as specified
in paragraph 6.

Quality system

5.1.

The manufacturer shall lodge an application for assessment of the quality system with a notified body of his
choice.

The application shall include:

> all relevant information for the instrument category envisaged;

> the documentation concerning the quality system;

> the technical documentation referred to in paragraph 2.

5.2.

The quality system shall ensure compliance of the instruments with the appropriate requirements of this
Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic
and orderly manner in the form of written policies, procedures and instructions. This quality system documen-
tation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

> the quality objectives and the organizational structure, responsibilities and powers of the management with

regard to product quality;

> the examinations and tests that will be carried out after manufacture;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc;

> the means to monitor the effective operation of the quality system.

5.3.

The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in
paragraph 5.2. It shall presume conformity with these requirements in respect of a quality system that complies
implements the relevant harmonised
with the corresponding specifications of
standard.

the national standard that

The auditing team shall include persons with experience in the instrument technology concerned and experience
as a legal metrology assessor. The evaluation procedure shall include an inspection visit to the manufacturer’s
premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of
examination and the reasoned assessment decision.

the

5.4.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.

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5.5.

The manufacturer shall keep the notified body that has approved the quality system informed of any intended
updating of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality system will
still satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination
and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

6.1.

6.2.

6.3.

6.4.

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes to the locations of inspection,
testing and storage, and shall provide it with all necessary information, in particular:

> the quality system documentation;

> the technical documentation referred to in paragraph 2;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the
quality system and shall provide an audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified
body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is
functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out,
with a test report.

Written declaration of conformity

7.1.

7.2.

The manufacturer shall affix the CE conformity marking, the supplementary metrology marking and, under the
responsibility of the notified body referred to in paragraph 5.1, the latter’s identification number to each
measuring instrument that satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

8.

The manufacturer shall, for a period ending ten years after the last instrument has been manufactured, keep at
the disposal of the national authorities:

> the documentation referred to in paragraph 5.1, second indent;

> the updating referred to in paragraph 5.5, as approved;

> the decisions and reports from the notified body referred to in paragraphs 5.5, 6.3 and 6.4.

9.

Each notified body shall periodically make available to all Member States the list of quality system approvals
issued or refused, and shall
immediately inform all Member States of the withdrawal of a quality system
approval.

Each Member State shall make this information available to the bodies which it has notified.

Authorised representative

10.

The manufacturer’s obligations contained in paragraphs 5.1, 5.5, 7.2 and 8 may be fulfilled, on his behalf and
under his responsibility, by his authorised representative established within the Community.

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DECLARATION OF CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

ANNEX F

1.

The declaration of conformity to type based on product verification is the part of a conformity assessment
procedure whereby the manufacturer or his authorised representative fulfils the obligations laid down hereafter
and ensures and declares that the measuring instruments that have been subjected to the provisions of point 3
are in conformity with the type as described in the EC type examination certificate and satisfy the appropriate
requirements of this Directive.

Manufacturing

2.

The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with
the approved type as described in the EC type examination certificate and the appropriate requirements of this
Directive.

Verification

3.

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have
them carried out, to check the conformity of the instruments with the type as described in the EC type
examination certificate and the appropriate requirements of this Directive.

The examinations and tests to check the conformity with the metrological requirements will be carried out, at
the choice of the manufacturer, either by examination and testing of every instrument as specified in paragraph
4, or by examination and testing of the instruments on a statistical basis as specified in paragraph 5.

4.

Verification of conformity with the metrological requirements by examination and testing of every instrument

4.1.

All instruments shall be individually examined and appropriate tests as set out in the relevant documents referred
to in Article 9, or equivalent tests, shall be carried out to verify their conformity with the metrological
requirements that apply to them. In the absence of a relevant document, the notified body concerned shall
decide on the appropriate tests to be carried out.

4.2.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and
shall affix its identification number to each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities.

5.

Statistical verification of conformity with the metrological requirements

5.1.

5.2.

The manufacturer shall have taken all measures necessary in order that the manufacturing process ensures the
homogeneity of each lot produced, and shall present his instruments for verification in the form of homo-
geneous lots.

A random sample shall be drawn from each lot according to the requirements of paragraph 5.3. All instruments
in the sample shall be individually examined and appropriate tests as set out in the relevant documents referred
to in Article 9, or equivalent tests, to establish their conformity with the metrological requirements that apply to
them shall be carried out to determine whether the lot is accepted or rejected. In the absence of a relevant
document, the notified body concerned shall decide on the appropriate tests to be carried out.

5.3.

The statistical procedure shall meet the following requirements:

The statistical control will be based on attributes. The sampling system shall ensure:

> a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of

less than 1 %;

> a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity percentage of less

than 7 %.

5.4.

If a lot is accepted all instruments of the lot are approved, except for those instruments from the sample that
were found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and
shall affix its identification number to each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities.

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5.5.

If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that
lot. In the event of frequent rejection of lots the notified body may suspend the statistical verification.

Written declaration of conformity

6.1.

6.2.

The manufacturer shall affix the CE conformity marking and the supplementary metrology marking to each
measuring instrument that is in conformity with the approved type and satisfies the appropriate requirements of
this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

If agreed upon by the notified body referred to in paragraph 3, the manufacturer shall also affix the notified
body’s identification number to the measuring instruments under the notified body’s responsibility.

7.

The manufacturer may, if agreed upon by the notified body and under its responsibility, affix the notified body’s
identification number to the measuring instruments during the manufacturing process.

Authorised representative

8.

The manufacturer’s obligations may be fulfilled, on his behalf and under his responsibility, by his authorised
representative established within the Community, except for the obligations contained in paragraphs 2 and 5.1.

DECLARATION OF CONFORMITY BASED ON PRODUCT VERIFICATION

ANNEX F1

1.

The declaration of conformity based on product verification is the conformity assessment procedure whereby the
manufacturer or his authorised representative fulfils the obligations laid down hereafter and ensures and declares
that the measuring instruments that have been subjected to the provisions of point 5 are in conformity with the
appropriate requirements of this Directive.

Technical documentation

2.

3.

The manufacturer shall establish the technical documentation as described in Annex IV. The documentation shall
enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It
shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of the national authorities for a period
ending ten years after the last instrument has been manufactured.

Manufacturing

4.

The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments with
the appropriate requirements of this Directive.

Verification

5.

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have
them carried out, to check the conformity of the instruments with the appropriate requirements of this
Directive.

The examinations and tests to check the conformity with the metrological requirements will be carried out, at
the choice of the manufacturer, either by examination and testing of every instrument as specified in paragraph
6, or by examination and testing of the instruments on a statistical basis as specified in paragraph 7.

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6.

Verification of conformity with the metrological requirements by examination and testing of every instrument

6.1.

All instruments shall be individually examined and appropriate tests as set out in the relevant documents referred
to in Article 9, or equivalent tests, shall be carried out to verify their conformity with the metrological
requirements that apply to them. In the absence of a relevant document, the notified body concerned shall
decide on the appropriate tests to be carried out.

6.2.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and
shall affix its identification number to each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities.

7.

7.1.

7.2.

Statistical verification of conformity with the metrological requirements

The manufacturer shall have taken all measures necessary in order that the manufacturing process ensures the
homogeneity of each lot produced, and shall present his instruments for verification in the form of homo-
geneous lots.

A random sample shall be drawn from each lot according to the requirements of paragraph 7.3. All instruments
in the sample shall be individually examined and appropriate tests as set out in the relevant documents referred
to in Article 9, or equivalent tests, to establish their conformity with the metrological requirements that apply to
them, shall be carried out to determine whether the lot is accepted or rejected. In the absence of a relevant
document, the notified body concerned shall decide on the appropriate tests to be carried out.

7.3.

The statistical procedure shall meet the following requirements:

The statistical control will be based on attributes. The sampling system shall ensure:

> a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of

less than 1 %;

> a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity percentage of less

than 7 %.

7.4.

If a lot is accepted all instruments of the lot are approved, except for those instruments from the sample that
were found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and
shall affix its identification number to each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities.

7.5.

If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that
lot. In the event of frequent rejection of lots the notified body may suspend the statistical verification.

Written declaration of conformity

8.1.

8.2.

The manufacturer shall affix the CE conformity marking and the supplementary metrology marking to each
measuring instrument that satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

If agreed upon by the notified body referred to in paragraph 5, the manufacturer shall also affix the notified
body’s identification number to the measuring instruments under the notified body’s responsibility.

9.

The manufacturer may, if agreed upon by the notified body and under its responsibility, affix the notified body’s
identification number to the measuring instruments during the manufacturing process.

Authorised representative

10.

The manufacturer’s obligations may be fulfilled, on his behalf and under his responsibility, by his authorised
representative established within the Community, except for the obligations contained in paragraphs 4 and 7.1.

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DECLARATION OF CONFORMITY BASED ON UNIT VERIFICATION

ANNEX G

1.

The declaration of conformity based on unit verification is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down hereafter and ensures and declares that a measuring instrument
that has been subjected to the provisions of paragraph 4, is in conformity with the appropriate requirements of
this Directive.

Technical documentation

2.

The manufacturer shall establish the technical documentation as described in Annex IV and make it available to
the notified body referred to in paragraph 4. The technical documentation shall enable assessment of the
conformity of the instrument with the appropriate requirements of this Directive and shall, as far as relevant
for such assessment, cover the design, manufacture and operation of the instrument.

Manufacturing

3.

The manufacturer shall take all measures necessary to ensure conformity of the manufactured instrument with
the appropriate requirements of this Directive.

Verification

4.

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests as set out in
the relevant documents referred to in Article 9, or equivalent tests, to check the conformity of the instrument
with the appropriate requirements of this Directive, or have them carried out. In the absence of a relevant
document, the notified body concerned shall decide on the appropriate tests to be carried out.

The notified body shall affix its identification number to the approved instrument, or have it affixed under its
responsibility.

Written declaration of conformity

5.1.

5.2.

The manufacturer shall affix the CE conformity marking and the supplementary metrology marking to the
measuring instrument that satisfies the appropriate requirements of this Directive.

A declaration of conformity shall be drawn up and kept at the disposal of the national authorities for a period
ending ten years after the instrument has been manufactured. It shall identify the instrument for which it was
drawn up.

A copy of the declaration shall be supplied with the measuring instrument.

Authorised representative

6.

The manufacturer’s obligations contained in paragraph 5.2 may be fulfilled, on his behalf and under his
responsibility, by his authorised representative established within the Community.

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DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE

ANNEX H

1.

The declaration of conformity based on full quality assurance is the conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down hereafter and ensures and declares that the measuring
instruments concerned satisfy the appropriate requirements of this Directive.

Manufacturing

2.

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection
and testing of the measuring instrument concerned as specified in paragraph 3, and shall be subject to
surveillance as specified in paragraph 4.

Quality system

3.1.

The manufacturer shall lodge an application for assessment of the quality system with a notified body of his
choice.

The application shall include:

> all relevant information for the instrument category envisaged;

> the documentation concerning the quality system.

3.2.

The quality system shall ensure compliance of the instruments with the appropriate requirements of this
Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic
and orderly manner in the form of written policies, procedures and instructions. This quality system documen-
tation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall
contain in particular an adequate description of:

> the quality objectives and the organisational structure, responsibilities and powers of the management with

regard to design and product quality;

> the technical design specifications, including standards, that will be applied and, where the standards referred
to in Article 9 will not be applied in full, the means that will be used to ensure that the essential
requirements of this Directive that apply to the instruments will be met;

> the design control and design verification techniques, processes and systematic actions that will be used

when designing the instruments pertaining to the instrument category covered;

> the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic

actions that will be used;

> the examinations and tests that will be carried out before, during and after manufacture, and the frequency

with which they will be carried out;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc.;

> the means to monitor the achievement of the required design and product quality and the effective operation

of the quality system.

3.3.

The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in
paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies
with the corresponding specifications of
implements the relevant harmonised
standard.

the national standard that

The auditing team shall include persons with experience in the instrument technology concerned and experience
as a legal metrology assessor. The evaluation procedure shall include an inspection visit to the manufacturer’s
premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of
examination and the reasoned assessment decision.

the

3.4.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.

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3.5.

The manufacturer shall keep the notified body that has approved the quality system informed of any intended
updating of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality system will
still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination
and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

4.1.

4.2.

4.3.

4.4.

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture,
inspection, testing and storage, and shall provide it with all necessary information, in particular:

> the quality system documentation;

> the quality records as foreseen by the design part of the quality system, such as results of analyses,

calculations, tests, etc.;

> the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports

and test data, calibration data, qualification reports of the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the
quality system and shall provide an audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified
body may, if necessary, carry out product tests, or have them carried out under its responsibility, to verify that
the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have
been carried out, with a test report.

Written declaration of conformity

5.1.

5.2.

The manufacturer shall affix the CE conformity marking, the supplementary metrology marking and, under the
responsibility of the notified body referred to in paragraph 3.1, the latter’s identification number to each
measuring instrument that satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up.

A copy of the declaration shall also be sent to one of the bodies notified for type examination according to
Article 8 whose responsibility it shall be to periodically make the list of declarations of conformity received
available to all Member States.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

6.

The manufacturer shall, for a period ending ten years after the last instrument has been manufactured, keep at
the disposal of the national authorities:

> the documentation concerning the quality system referred to in paragraph 3.1, second indent;

> the updating referred to in paragraph 3.5, as approved;

> the decisions and reports from the notified body referred to in paragraphs 3.5, 4.3 and 4.4.

7.

Each notified body shall periodically make available to all Member States the list of quality system approvals
immediately inform all Member States of the withdrawal of a quality system
issued or refused, and shall
approval.

Each Member State shall make this information available to the bodies which it has notified.

Authorised representative

8.

The manufacturer’s obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and
under his responsibility, by his authorised representative established within the Community.

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DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

ANNEX H1

1.

The declaration of conformity based on full quality assurance plus design examination is the conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down hereafter and ensures and
declares that the measuring instruments concerned satisfy the appropriate requirements of this Directive.

Manufacturing

2.

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection
and testing of the measuring instrument concerned as specified in paragraph 3, and shall be subject to
surveillance as specified in paragraph 5. The adequacy of the technical design of the measuring instrument
shall have been examined according to the provisions of paragraph 4.

Quality system

3.1.

The manufacturer shall lodge an application for assessment of the quality system with a notified body of his
choice.

The application shall include:

> all relevant information for the instrument category envisaged;

> the documentation concerning the quality system.

3.2.

The quality system shall ensure compliance of the instruments with the appropriate requirements of this
Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic
and orderly manner in the form of written policies, procedures and instructions. This quality system documen-
tation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall
contain in particular an adequate description of:

> the quality objectives and the organisational structure, responsibilities and powers of the management with

regard to design and product quality;

> the technical design specifications, including standards, that will be applied and, where the standards referred
to in Article 9 will not be applied in full, the means that will be used to ensure that the essential
requirements of this Directive that apply to the instruments will be met;

> the design control and design verification techniques, processes and systematic actions that will be used

when designing the instruments pertaining to the instrument category covered;

> the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic

actions that will be used;

> the examinations and tests that will be carried out before, during and after manufacture, and the frequency

with which they will be carried out;

> the quality records, such as inspection reports and test data, calibration data, qualification reports of the

personnel concerned, etc.;

> the means to monitor the achievement of the required design and product quality and the effective operation

of the quality system.

3.3.

The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in
paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies
with the corresponding specifications of
implements the relevant harmonised
standard.

the national standard that

The auditing team shall include persons with experience in the instrument technology concerned and experience
as a legal metrology assessor. The evaluation procedure shall include an inspection visit to the manufacturer’s
premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of
examination and the reasoned assessment decision.

the

3.4.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.

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3.5.

The manufacturer shall keep the notified body that has approved the quality system informed of any intended
updating of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality system will
still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination
and the reasoned assessment decision.

Design examination

4.1.

4.2.

The manufacturer shall lodge an application for examination of the design with the notified body referred to in
item 3.1.

The application shall enable understanding of the design, manufacture and operation of the instrument, and shall
enable assessment of conformity with the appropriate requirements of this Directive. It shall include:

> the name and address of the manufacturer;

> a written declaration that the same application has not been lodged with any other notified body;

> the technical documentation as described in Annex IV. The documentation shall enable assessment of the
conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant
for such assessment, cover the design and operation of the instrument;

> the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention
any standards that have been applied, in particular where the standards referred to in Article 9 have not
been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate
laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4.3.

The notified body shall examine the application, and where the design meets the provisions of the Directive that
apply to the measuring instrument it shall issue an EC design examination certificate to the applicant. The
certificate shall contain the name and address of the manufacturer, conclusions of the examination, conditions (if
any) for its validity and the necessary data for identification of the approved instrument.

All relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the
notified body.

The certificate shall have a validity period of ten years from the date of its issue,

If the manufacturer is denied a design examination certificate, the notified body shall provide detailed reasons for
such a denial.

4.4.

The manufacturer shall keep the notified body that has issued the EC design examination certificate informed of
any modification to the approved design. Modifications to the approved design must receive additional approval
from the notified body that issued the EC design examination certificate where such changes may affect the
conformity with the essential requirements of this Directive, the conditions for validity of the certificate or the
prescribed conditions for use of the instrument. This additional approval is given in the form of an addition to
the original EC design examination certificate.

4.5.

Each notified body shall periodically make available to all Member States the list of:

> EC design examination certificates issued;

> EC design examination certificates refused;

> additions and amendments relating to certificates already issued.

Each notified body shall inform all Member States immediately of the withdrawal of an EC design examination
certificate.

Each Member State shall make this information available to the bodies which it has notified.

4.6.

The other notified bodies may receive a copy of the EC design examination certificates and/or their additions.
The annexes to the certificates shall be kept at the disposal of the other notified bodies.

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4.7.

The manufacturer or his authorised representative established within the Community shall keep a copy of the EC
design examination certificate and its additions with the technical documentation for a period ending 10 years
after the last measuring instrument has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the
obligation to keep the technical documentation available shall be the responsibility of the importer or any other
person who places the measuring instrument on the Community market.

Surveillance under the responsibility of the notified body

5.1.

5.2.

5.3.

5.4.

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design,
manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:

> the quality system documentation;

> the quality records as foreseen by the design part of the quality system, such as results of analyses,

calculations, tests, etc.;

> the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports

and test data, calibration data, qualification reports of the personnel concerned, etc.

The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the
quality system and shall provide an audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified
body may, if necessary, carry out product tests, or have them carried out under its responsibility, to verify that
the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have
been carried out, with a test report.

Written declaration of conformity

6.1.

6.2.

The manufacturer shall affix the CE conformity marking, the supplementary metrology marking and, under the
responsibility of the notified body referred to in paragraph 3.1, the latter’s identification number to each
measuring instrument that satisfies the appropriate requirements of this Directive.

A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the
national authorities for a period ending ten years after the last instrument has been manufactured. It shall
identify the model of the instrument for which it was drawn up and shall mention the number of the design
examination certificate.

A copy of the declaration shall be supplied with each measuring instrument that is placed on the market.

7.

The manufacturer shall, for a period ending ten years after the last instrument has been manufactured, keep at
the disposal of the national authorities:

> the documentation referred to in 3.1, second indent;

> the updating referred to in paragraph 3.5, as approved;

> the decisions and reports from the notified body referred to in paragraphs 3.5, 5.3 and 5.4.

8.

Each notified body shall periodically make available to all Member States the list of quality system approvals
issued or refused, and shall
immediately inform all Member States of the withdrawal of a quality system
approval.

Each Member State shall make this information available to the bodies which it has notified.

Authorised representative

9.

The manufacturer’s obligations contained in paragraphs 3.1, 3.5, 6.2 and 7 may be fulfilled, on his behalf and
under his responsibility, by his authorised representative established within the Community.

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ANNEX MI-001

WATER METERS

this Annex and the conformity assessment
The relevant requirements of Annex I,
procedures listed in this Annex apply to water meters intended for the measurement of volumes of clean, cold or
heated water used in non-negotiated transactions.

the specific requirements of

DEFINITIONS

Water meter

An instrument intended to measure, memorise and display the volume at metering conditions of water passing through
the measurement transducer.

Minimum flowrate (Q1)

The lowest flowrate at which the water meter provides indications that satisfy the requirements concerning the
maximum permissible errors.

Transitional flowrate (Q2)

The transitional flowrate is the flowrate value occurring between the permanent and minimum flowrates, at which the
flowrate range is divided into two zones, the Aupper zoneB and the Alower zoneB. Each zone has a characteristic maximum
permissible error.

Permanent flowrate (Q3)

The highest flowrate at which the water meter operates in a satisfactory manner under normal conditions of use, i.e.
under steady or intermittent flow conditions.

Overload flowrate (Q4)

The overload flowrate is the highest flowrate at which the meter operates in a satisfactory manner for a short period of
time without deteriorating.

SPECIFIC REQUIREMENTS

Rated operating conditions

The manufacturer shall specify the rated operating conditions for the instrument, in particular;

1.

The flowrate range of the water.

The values for the flowrate range shall fulfil the following conditions:

Q3/Q1 ‡ 10

Q2/Q1 = 1,6

Q4/Q3 = 1,25

For a period of 5 years from the adoption of this directive the ratio Q2/Q1 may be: 1,5, 2,5, 4, or 6,3.

2.

The temperature range of the water.

The values for the temperature range shall fulfil the following conditions:

0,1 MC to at least 30 MC, or

30 MC to a high temperature, that temperature being at least 90 MC.

The meter may be designed to operate over both ranges.

3.

The relative pressure range of the water, the range being 0,3 bar to at least 10 bar.

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4.

5.

The climatic and mechanical environment class B, C, E or F in which the instrument is intended to be used in
accordance with Table 1 of Annex I.

For the power supply: the nominal value of the AC voltage supply and/or the limits of DC supply.

Maximum permissible error

6.

7.

The maximum permissible error, positive or negative, on volumes delivered at flowrates between the transitional
flowrate (Q2) (included) and the overload flowrate (Q4) is:

2 % for water having a temperature £ 30 MC,

3 % for water having a temperature > 30 MC.

The maximum permissible error, positive or negative, on volumes delivered at flowrates between the minimum
flowrate (Q1) and the transitional flowrate (Q2) (excluded) is 5 % for water having any temperature.

Permissible effect of disturbances

8.1.

Electromagnetic immunity

8.1.1. The manufacturer shall specify the electromagnetic environment E1 or E2 in which the instrument is intended to

be used in accordance with requirement 1.3.2 of Annex I.

8.1.2. The effect of an electromagnetic disturbance on a water meter shall be such that:

> the change in the measurement result is no greater than the critical change value as defined in 8.1.4, or

> the indication of the measurement result is such that it cannot be interpreted as a valid result, such as a

momentary variation that cannot be interpreted, memorised or transmitted as a measuring result.

8.1.3. After undergoing an electromagnetic disturbance the water meter shall:

> recover to operate within maximum permissible error, and

> have all measurement functions safeguarded, and

> allow recovery of all measurement data present just before the disturbance.

8.1.4. The critical change value is the value of the maximum permissible error applied to the quantity corresponding to

one minute at flowrate Q3.

Suitability

9.1.

The meter shall be able to be installed to operate in any position unless clearly marked otherwise.

9.2.

The manufacturer shall specify whether the meter is designed to measure reverse flow. In such a case, the reverse
flow volume shall either be subtracted from the cumulated volume or shall be separately recorded. The same
maximum permissible error shall apply to both forward and reverse flow.

Water meters not designed to measure reverse flow shall be capable of withstanding an accidental reverse flow
without any deterioration or change in metrological properties, and at the same time record such a reversal.

Units of measurement

10.

Metered volume shall be displayed in cubic metres, symbol m3.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: B+F, B+D, H1.

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Official Journal of the European Communities

27.2.2001

ANNEX MI-002

GAS METERS

this Annex and the conformity assessment
The relevant requirements of Annex I,
procedures listed in this Annex apply to gas meters defined below intended for use in non-negotiated transactions.

the specific requirements of

DEFINITIONS

Gas meter

An instrument intended to measure, memorise and display the quantity of gas passing through the measurement
transducer.

Conversion device

A device fitted to a gas meter that automatically converts the quantity measured at metering conditions into a quantity
at base conditions.

Minimum flowrate (Qmin)

The lowest flowrate at which the gas meter provides indications that satisfy the requirements regarding maximum
permissible error.

Maximum flowrate (Qmax)

The highest flowrate at which the gas meter provides indications that satisfy the requirements regarding maximum
permissible error.

Transitional flowrate (Qt)

The transitional flowrate is the flowrate occurring between the maximum and minimum flowrates at which the flowrate
range is divided into two zones, the Aupper zoneB and the Alower zoneB. Each zone has a characteristic maximum
permissible error.

Overload flowrate (Qr)

The overload flowrate is the highest flowrate at which the meter operates for a short period of time without deterio-
rating.

Base conditions

The specified conditions to which the measured quantity of fluid is converted.

SPECIFIC REQUIREMENTS

Rated operating conditions

The manufacturer shall specify the rated operating conditions of the instrument, in particular;

1.

The flowrate range of the gas.

The values for the flowrate range shall fulfil the following conditions:

Qmax/Qmin > 20

Qmax/Qt ‡ 5

Qr/Qmax = 1,2

2.

The temperature range of the gas, with a minimum range of 40 MC.

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3.

The fuel gas related conditions.

The instrument shall be designed for the range of gases and supply pressures of the country of destination. In
particular the manufacturer shall indicate:

> the gas family or group;

> the maximum operating pressure.

4.

The climatic and mechanical environment in which the instrument or its sub-assemblies are intended to be used
in accordance with Table 1 of Annex I, with a minimum temperature range of 60 MC.

5.

For the power supply: the nominal value of the AC voltage supply and/or the limits of DC supply.

Base conditions for converted values

6.

The manufacturer shall specify the base conditions for converted values.

Maximum permissible error

7.1.

Gas meter

Accuracy class

Qmin £ Q < Qt

Qt £ Q £ Qmax

Table 1

1,5

3 %

1,5 %

1

2 %

1 %

When the errors between Qt and Qmax all have the same sign, they shall all not exceed 1 % for class 1,5 and
0,5 % for Class 1.

7.2.

Change in maximum permissible error due to a conversion device.

7.2.1.

For an integrated temperature conversion device that only converts volume as a function of the temperature and
only indicates the converted volume, the maximum permissible error of the meter is increased by 0,5 % in a
range of 10 MC extending symmetrically around the temperature specified by the manufacturer that lies between
15 MC and 25 MC. Outside this range an additional increase of 0,5 % is permitted.

7.2.2. For conversion devices other than those covered by 7.2.1 the maximum permissible error is increased by 1 %.

Permissible effect of disturbances

8.1.

Electromagnetic immunity

8.1.1. The manufacturer shall specify the electromagnetic environment E1 or E2 in which the instrument is intended to

be used in accordance with requirement 1.3.2 of Annex I.

8.1.2. The effect of an electromagnetic disturbance on a gas meter shall be such that:

(i) the change in measurement is no greater than the critical change value as defined in 4.1.4, or

(ii) the indication of the measurement result is such that it cannot be interpreted as a valid result, such as a

momentary variation that cannot be interpreted, memorised or transmitted as a measuring result.

8.1.3. After undergoing a disturbance the gas meter shall:

> recover to operate within maximum permissible error, and

> have all measurement functions safeguarded, and

> allow recovery of all measurement data present just before the disturbance.

8.1.4. The critical change value is the value of the maximum permissible error applied to the quantity corresponding to

one minute at flowrate Qmax.

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Suitability

An instrument powered from the mains (AC or DC) shall be provided with an emergency power supply device
or other means to assure during a failure of the principal power source that all measuring functions are
safeguarded.

A dedicated power source shall have a lifetime of at least five years. After 90 % of its lifetime an appropriate
warning shall be shown.

An indicating device shall have a sufficient number of digits to ensure that the quantity passed during at least
two years at normal operation does not return the digits to their initial values.

The meter shall be able to be installed to operate in any position unless clearly marked otherwise.

An electronic conversion device shall be capable of detecting when it is operating outside the operating range(s)
stated by the manufacturer for parameters that are relevant for measurement accuracy. In such a case the
conversion device must stop integrating the converted quantity, and may totalise separately the converted
quantity for the time it is outside the operating range(s).

9.1.

9.2.

9.3.

9.4.

9.5.

Units

10.

Metered volume shall be displayed in cubic metre, symbol m3.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: B+F, B+D, H1.

ANNEX MI-003

Active electrical energy meters and measurement transformers

this Annex and the conformity assessment
The relevant requirements of Annex I,
procedures listed in this Annex apply to active electrical energy meters of accuracy classes 1 and 2, and to measurement
transformers for use in combination with any such active electrical energy meter.

the specific requirements of

DEFINITIONS

An active electrical energy meter is a device which measures the active electrical energy consumed in a circuit since the
moment at which the display indicated zero. It may be used in combination with a measurement transformer, depending
upon the measurement technique applied.

A measurement transformer is a device for use in combination with an active electrical energy meter, which offers to the
meter a reduced value of the voltage at which the electricity is being supplied to the circuit, and/or a reduced value of
the current flowing in the circuit, the reduction factors being constant.

I

= the electrical current flowing through the meter;

= the nominal value of I for which the meter has been designed;

= the lowest value of I at which the meter measures active electrical energy;

In
Ist
Imin = the value of I from which onwards the error is intended to lie within prescribed limits;
Itr

= the value of I from which onwards the error is intended to lie within the error limits corresponding to the
accuracy class declared for the meter;

Imax = the maximum value of I for which the meter has been designed;
U

= the potential of the electricity supplied to the meter;

Un
f

fn
PF

T

= the nominal value of U for which the meter has been designed;

= the frequency of the electrical current flowing through the meter;

= the nominal value of f for which the meter has been designed;

= power factor = cos(cid:2) = the phase difference between I and U;

= ambient temperature.

SPECIFIC REQUIREMENTS

PART 1 > METERS

1.

The manufacturer shall specify the values of fn, Un, In, Imin, Itr and Imax that apply to the meter. The values
chosen shall fulfil the following conditions:
Imin/Ist ‡ 10;
Itr/Ist ‡ 20;
Imax/Ist ‡ 200.

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Design prescriptions

2.

In the case of electrical energy meters designed for use in combination with a measurement transformer, Imax
shall be equal to 1,2.In.

Quality of the electricity

3.

A meter shall satisfy the accuracy requirements laid down in this Annex in the case of electricity with a quality
as specified hereafter.

No legal requirements in respect of metrological performance apply when the electricity has a quality, even
momentarily, which is worse than the quality specified hereafter.

The voltage and frequency values lie within the following limits:

0,9.Un £ U £ 1,1.Un;

0,98.fn £ f £ 1,02.fn.

The power factor lies within the following limits:

From cos(cid:2) = 0,5 inductive to cos(cid:2) = 0,8 capacitive.

Rated operating conditions

4.

The manufacturer shall specify the climatic and mechanical environment class B or class C for which the meter
has been designed in accordance with Table 1 of Annex I.

Accuracy classes

5.

The following accuracy classes are defined: Class 1, Class 2.

Maximum permissible errors

6.

Table 1 shows the maximum errors, expressed in percent of the true value, that must be respected by the
electrical energy meter under rated operating conditions for electricity with a quality within the limits specified
in requirement 3 of this Annex.

Table 1

Maximum permissible errors (percent of true value)

Electrical current flowing through the meter

PF

Accuracy class

1

2

Single phase meter; Polyphase meter, if operating with balanced loads

Itr £ I £ Imax

2Itr £ I £ Imax

Imin £ I < Itr

2Imin £ I < 2Itr

Itr £ I £ Imax

2Itr £ I £ Imax

1

„ 1

1

„ 1

1 + ˜

1 + ˜

1,5 + ˜

1,5 + ˜

Polyphase meter, if operating with single phase load

1

„ 1

2 + ˜

2 + ˜

2 + ˜

2 + ˜

2,5 + ˜

2,5 + ˜

3 + ˜

3 + ˜

˜ = k1 + k2 + k3(T-Tn), where the values of k1, k2 and k3 are given in Table 2.

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Table 2

k values for use in Table 1

Condition

K1

U within the quality limits, and U „ Un

Idem

U = Un

K2

f within the quality limits, and f „ fn

Idem

f = fn

K3

T within rated conditions

Idem

Accuracy class

PF

1

„ 1

1

„ 1

1

„ 1

1

0,7

1

0

0,5

0,7

0

0,05

0,07

2

1

1,5

0

0,8

1

0

0,1

0,15

Permissible effect of disturbances

7.1.

Electromagnetic immunity

7.1.1. The manufacturer shall specify the electromagnetic environment E1 or E2 for which the electrical energy meter

has been designed in accordance with requirement 1.3.2 of Annex I.

7.1.2. The change in accuracy of an electrical energy meter due to the presence of an electromagnetic disturbance shall
be less than the critical value given in Table 3, or the indication of the measurement result shall be such that it
cannot be interpreted as a valid measurement result, such as a momentary variation that cannot be interpreted,
memorised or transmitted as a measuring result.

Critical values of the change in accuracy under disturbances (percentage values are percent of true
value)

Table 3

Disturbance

Electromagnetic disturbances

Electromagnetic field

Magnetic induction

Electrostatic discharge

Accuracy class

1

3 %

2 %

2

4 %

3 %

10-6TmTUnTImax kWh
where m = the no. of measuring elements

7.1.3. After having undergone an electromagnetic disturbance, the electrical energy meter shall

> recover to operate within maximum permissible error, and

> have all measurement functions safeguarded, and

> allow recovery of all measurement data present immediately before the occurrence of the disturbance.

Other requirements

8.

9.

A meter shall have a display, visible by the consumer when installed in the normal installation position as
specified by the manufacturer.

The display shall have a sufficient number of digits to ensure that the indication doesn’t return to its initial value
when the active electrical energy consumed in the circuit corresponds to operation of the meter for 1 500 h at
I = Imax, U = Un and PF = 1.

10. When the electrical energy measured is indicated in different displays corresponding to different tariffs, the meter

shall indicate the active tariff.

11.

During use, it shall be impossible to reset the indication of the quantity of electrical energy measured.

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12.

A meter with a prepayment device shall show the value of the credit remaining.

The error of the value of electrical energy consumed per unit decrease of the credit remaining shall be £ 1 scale
interval.

In the event of loss of electricity in the circuit, the amounts of electrical energy measured shall remain available
for reading during a period of at least 4 months.

13.

Units

14.

The electrical energy measured shall be displayed in kilowatt-hours, symbol kWh.

PART 2 > MEASUREMENT TRANSFORMERS

Quality of the electricity

15.

A measurement transformer shall satisfy the accuracy requirements laid down in this Annex in the case of
electricity with a quality as specified in requirement 3 of this Annex.

No legal requirements in respect of metrological performance apply when the electricity has a quality, even
momentarily, which is worse than the quality specified in requirement 3 of this Annex.

Rated operating conditions

16.

The manufacturer shall specify the climatic and mechanical environment class B or class C for which the
measurement transformer has been designed in accordance with Table 1 of Annex I.

Accuracy classes

The following accuracy classes are defined for measurement transformers intended for use in combination with an

17.
active electrical energy meter 0,1 - 0,2 - 0,5.

Maximum permissible errors

18.

Table 4 shows the maximum errors, expressed in percent of the true value of the active electrical energy
measured, that must be respected by the measurement transformer under rated operating conditions for elec-
tricity with a quality as specified in requirement 3 of this Annex.

Maximum permissible errors (percent of true value)

Table 4

Accuracy class

0,1

0,2

0,5

Current transformers for use in combination with induction type meters

I = 0.05 In

I = 0.20 In

I = In

I = 1.2 In

I = 0.01 In

I = 0.05 In

I = 0.20 In

I = In

I = 1.2 In

0,4

0,2

0,1

0,1

Current transformers for use in combination with static meters

0,75

0,35

0,2

0,2

0,75

0,35

0,2

0,2

0,2

1,5

0,75

0,5

0,5

1,5

0,75

0,5

0,5

0,5

I = any value

0,1

0,2

0,5

Voltage transformer

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: B+F, B+D, H1.

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27.2.2001

ANNEX MI-004

HEAT METERS

The relevant requirements of Annex I,
procedures listed in this Annex apply to heat meters defined below.

the specific requirements of

this Annex and the conformity assessment

DEFINITIONS

A heat meter is an instrument intended for measuring the heat which, in a heat exchange circuit, is absorbed or given
up by a liquid called the heat conveying liquid.

A heat meter is either a complete instrument or an instrument made up of the sub-assemblies flow sensor, temperature
sensor pair, and calculator, as defined in Article 3.2, or a combination of these.

Ł

Łin

Łout

˜Ł

Łmax

Łmin

= the temperature of the heat conveying liquid;

= the value of Ł at the inlet of the heat exchange circuit;

= the value of Ł at the outlet of the heat exchange circuit;

= Łin - Łout;

= the upper limit of Ł for the heat meter to function correctly;

= the lower limit of Ł for the heat meter to function correctly;

˜Łmax = the upper limit of ˜Ł for the heat meter to function correctly;

˜Łmin = the lower limit of ˜Ł for the heat meter to function correctly;

q

qs

qp

qi

P

Ps

= the flow rate of the heat conveying liquid;

= the highest value of q that is permitted for short periods of time for the heat meter to function correctly;

= the highest value of q that is permitted permanently for the heat meter to function correctly;

= the lowest value of q that is permitted for the heat meter to function correctly;

= the thermal power of the heat exchange;

= the upper limit of P that is permitted for the heat meter to function correctly.

SPECIFIC REQUIREMENTS

PART 1 > METERS

Rated operating conditions

1.

The rated values of the operating conditions shall be specified by the manufacturer as follows:

1.1.

For the temperature of the liquid:

Łmax, Łmin, ˜Łmax, ˜Łmin, subject to the following restrictions:

˜Łmax/˜Łmin ‡ 10;

˜Łmin = 2K.

1.2.

For the pressure of the liquid:

The maximum positive internal pressure that the heat meter can withstand permanently at the upper limit of
the temperature range.

1.3.

For the flow rate of the liquid:

qs, qp, qi, where the values of qp and qi are subject to the following restriction:

qp/qi ‡ 10.

1.4.

For the thermal power:

Ps.

1.5.

For the climatic and mechanical influence quantities:

The environment class B, C, E or F for which the meter has been designed, in accordance with Table 1 of
Annex I.

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Accuracy classes

2.

The following accuracy classes are defined for heat meters: class 2, class 3.

Maximum permissible errors

3.

The maximum permissible errors for the accuracy classes, expressed in percent of the true value, are:

For class 2: mpe = (3 + 4.˜Łmin/˜Ł + 0,02.qp/q)

For class 3: mpe = (4 + 4.˜Łmin/˜Ł + 0,05.qp/q)

Permissible effect of disturbances

4.1.

Electromagnetic immunity

4.1.1. The manufacturer shall specify the electromagnetic environment E1 or E2 in which the instrument is intended to

be used in accordance with requirement 1.3.2 of Annex I.

4.1.2. The effect of an electromagnetic disturbance shall be such that:

the change in the measurement result is no greater than the critical change value as laid down in requirement
4.1.3, or

the indication of the measurement result is such that it cannot be interpreted as a valid result.

4.1.3. The critical change value is 0,5 of the mpe.

PART 2 > SUB-ASSEMBLIES

5.

Where a heat meter is made up of sub-assemblies according to Article 4.3, the essential requirements for the
heat meter apply to the sub-assemblies as relevant. In addition, the following requirements apply:

5.1.

For the flow sensor:

Class 2: Ef = (2 % + 0,02 qp/q), but not more than – 5 %

Class 3: Ef = (3 % + 0,05 qp/q), but not more than – 5 %

where the error Ef relates the indicated value to the true value of the relationship between flow sensor output
signal and mass or volume.

5.2.

For the temperature sensor pair:

Et = (0,5 % + 3˜Łmin/˜Ł)

where the error Et relates the indicated value to the true value of the relationship between temperature sensor
pair output and temperature difference.

5.3.

For the calculator:

Ec = (0,5 % +˜Łmin/˜Ł)

where the error Ec relates the value of the heat indicated to the true value of the heat.

5.4.

For the combination of partial errors:

When the errors of a heat meter are determined from errors of subassemblies, the error of the heat meter is the
arithmetic sum of the errors of the subassemblies.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: B+F, B+D, H1.

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MEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC MEASUREMENT OF QUANTITIES OF
LIQUIDS OTHER THAN WATER

ANNEX MI-005

The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment
procedures listed in this Annex apply to measuring systems intended for the continuous and dynamic measurement of
quantities of liquids other than water.

DEFINITIONS

Meter

An instrument designed to measure continuously, memorise and display the quantity at metering conditions of liquid
flowing through the measurement transducer in a closed, fully surcharged conduit.

Measuring system

A system that comprises the meter itself and all devices required to ensure correct measurement or intended to facilitate
the measuring operations.

Minimum measured quantity

The minimum measured quantity is the smallest quantity of
acceptable for the measuring system.

liquid for which the measurement is metrologically

Base conditions

The specified conditions to which the measured quantity of liquid is converted.

Transfer point

A point at which the liquid is defined as being delivered or received.

SPECIFIC REQUIREMENTS

1.

FLOWRATE RANGE

The flowrate range is specified by the manufacturer subject to the following conditions;

(i) the flowrate range of a measuring system shall be within the flowrate range of each of its elements;

(ii) Meter

Table 1

Characteristic of liquid

Liquefied
‡ 20 mPa.s

gases

(incl. Cryogenics)

or

viscosity

All other liquids

(iii) Measuring system

Minimum ratio of
Qmax: Qmin

5:1

10:1

Table 2

Specific measuring system

Characteristic of liquid

Fuel system for motor vehicles

Not LPG

LPG

Measuring system

Cryogenic liquids

Measuring systems on pipelines or for loading/
unloading ships

All other measuring systems

>

>

Minimum ratio of
Qmax: Qmin

10:1

5:1

5:1

Free choice

2:1

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2.

PROPERTIES OF THE LIQUID

The manufacturer shall specify the properties of the liquid by specifying the name or type of liquid or its
relevant characteristics as follows:

> Temperature range;

> Pressure range;

> Density range;

> Viscosity range.

3.

RATED OPERATING CONDITIONS

The manufacturer shall specify the rated operating conditions for the instrument, in particular:

(i) the climatic and mechanical environment class B, C or I in which the instrument is intended to be used in

accordance with Table 1 of Annex I, and observing the following conditions for temperature range:

> minimum range of 50 MC for classes C and I

> minimum range of 30 MC for class B

(ii) power supply: nominal AC voltage supply and/or limits of DC supply.

(iii) the base conditions for converted values.

4.

ACCURACY CLASSIFICATION AND MAXIMUM PERMISSIBLE ERRORS

4.1.

For quantities equal to or greater than two litres or the mass equivalent, the maximum permissible errors on
indications are:

Measuring systems (A)

Meters (B)

Table 3

0,3

0,3 %

0,2 %

0,5

0,5 %

0,3 %

Accuracy class

1,0

1,0 %

0,6 %

1,5

1,5 %

1,0 %

2,5

2,5 %

1,5 %

4.2.

For quantities less than two litres or the mass equivalent, the maximum permissible errors on indications are:

Measured quantity - V

Maximum permissible error

Table 4

V < 0,1 L

0,1 L £ V < 0,2 L

0,2 L £ V < 0,4 L

0,4 L £ V < 1 L

1 L £ V < 2 L

4 H value in Table 3, applied to 0,1 L

4 H value in Table 3

2 H value in Table 3, applied to 0,4 L

2 H value in Table 3

value in Table 3, applied to 2 L

Note: values given in litres are converted to the mass equivalent value for mass measuring instruments

4.3.

However, no matter what the measured quantity may be, the magnitude of the maximum permissible error is
given by the greater of the following two values:

> the absolute value of the maximum permissible error given in Table 3 or Table 4.

> the absolute value of the maximum permissible error for the minimum measured quantity (Emin).

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4.4.1. Vmin ‡ 2 litres or mass equivalent

For minimum measured quantities greater than or equal to two litres or the mass equivalent,

Alternative 1

Emin shall fulfil the condition: Emin > 2R, where R is the resolution of the indicating device.

Alternative 2

Emin is given by the formula: Emin = (2 Vmin) H (A/100), where:

> Vmin is the minimum measured quantity,

> A is the numerical value specified in line A of Table 3.

4.4.2. Vmin < 2 litres or mass equivalent

For minimum measured quantities less than two litres or the mass equivalent, Emin is twice the value specified in
Table 4, and related to line A of Table 3.

4.5.

Conversion to base conditions

In case of converted indication to volume at base conditions or to mass the maximum permissible errors are as
in line A of Table 3.

4.6.

Conversion devices

Maximum permissible errors on converted indications due to a conversion device are equal to – (A - B), A and B
being the values specified in Table 1. However the magnitude of the maximum permissible error shall not be less
than the greater of the two following values:

> one-half scale interval of the indicating device for converted indications,

> half of the value corresponding to Emin.

Parts of conversion devices that can be tested separately.

(a) Calculator

Maximum permissible error on quantities of liquid indications applicable to calculation, positive or negative, are
equal to one-tenth of the maximum permissible error defined in line A of Table 3. However the magnitude of
the maximum permissible error shall not be less than one half scale interval of the measuring system in which
the calculator is intended to be used.

(b) Sensors

Sensors shall have an accuracy at least as good as the values in Table 5:

MPE on Measurements

Temperature

Pressure

Table 5

Accuracy classes of the measuring system

0,3

0,5

1,0

1,5

2,5

– 0,3 MC

– 0,5 MC

– 1,0 MC

Less than 1 Mpa: – 50 k Pa
From 1 to 4 Mpa: – 5 %
Over 4 Mpa: – 200 kPa

Density

– 1 kg/m3

– 2 kg/m3

– 5 kg/m3

(c) Accuracy for calculating function

The maximum permissible error for the calculation of each characteristic quantity of the liquid, positive or
negative,
is equal to two fifths of the value fixed in (b) above. However the magnitude of the maximum
permissible error shall not be less than one-half scale interval of the indicating device for converted indications.

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5.

MAXIMUM PERMISSIBLE EFFECT OF DISTURBANCES

5.1.

The manufacturer shall specify the electromagnetic environment E1 or E2 in which the instrument is intended to
be used in accordance with requirement 1.3 2 of Annex I.

5.2.

The effect of an electromagnetic disturbance on a measuring system shall be one of the following;

> the change in the measurement result is no greater than the critical change value as defined in 5.3, or

> the indication of

the measurement result shows a momentary variation that cannot be interpreted,
memorised or transmitted as a measuring result. Furthermore, in the case of an interruptible system this
can also mean the impossibility to perform any measurement, or

> the change in the measurement result is greater than the critical change value in which case the measuring
system shall permit the retrieval of the measuring result just before the critical change value occurred and
cut off the flow in the case of an interruptible system.

5.3.

The critical change value is the greater of MPE/5 for a particular measured quantity or Emin.

6.

DURABILITY

6.1.

An instrument shall be designed so that it can respect twice the maximum permissible error without adjustment
during a period of one year of normal service after its first putting into use.

7.

7.1.

SUITABILITY

For any measured quantity relating to the same measurement, the indications provided by various devices shall
not deviate one from another by more than one scale interval where devices have the same scale interval. In the
case where the devices have different scale intervals the deviation shall not be more than that of the greatest
scale interval.

However, in the case of self-service systems the scale intervals of all devices indicating the result of measurement
shall be the same and results shall not deviate one from another.

7.2.

A measuring system shall normally incorporate only one transfer point. When more than one transfer point is
present under no circumstances shall it be possible to divert measured liquid.

7.3.

Any percentage of air or gas not easily detectable in the liquid shall not lead to a variation of error greater than:

> 0,5 % for liquids other than potable liquids and for liquids of a viscosity not exceeding 1 mPa.s, or

> 1 % for potable liquids and for liquids of a viscosity exceeding 1 mPa.s.

> However, the allowed variation shall never be smaller than 1 % of Vmin. This value applies in the case of air

or gas pockets.

7.4.

Instruments for direct sales

7.4.1. A measuring system for direct sales shall be provided with means for resetting the display to zero.

7.4.2. The display of volume at metering conditions shall be permanent.

7.5.

Fuel dispensers for motor vehicles

7.5.1. Displays on fuel dispensers for motor vehicles shall not be capable of being reset to zero during a measurement.

7.5.2. The start of a new measurement shall be inhibited until the display has been reset to zero.

7.5.3. Where a measuring system is fitted with a price display, the difference between the indicated price and the price
calculated from the unit price and the indicated quantity shall not exceed the price corresponding to Emin.
However this difference need not be less than the smallest monetary value.

8.

POWER SUPPLY FAILURE

8.1.

A non-interruptible measuring system shall be provided with an emergency power supply device that will
safeguard all measuring functions during the failure of the main power supply device.

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8.2.

An interruptible measuring system shall either comply with the above requirement for non-interruptible systems
or be equipped with means to save and display the data present in order to permit the conclusion of the
transaction in progress and with means to stop the flow at the moment of the failure of the main power supply
device.

The absolute value of the maximum permissible error for the indicated quantity is increased by 5 % of the
minimum measured quantity.

9.

ACCURACY CLASSES AND USES

Minimum accuracy
class

0,3

0,5

Types of measuring system

> Measuring systems on pipeline

> All measuring systems if not differently stated elsewhere in this Table, in particular:

> fuel dispensers for motor vehicles (other than LPG),

> measuring systems on road tankers for liquids of low viscosity

> measuring systems for unloading ship’s tanks and rail and road tankers

> measuring systems for milk

> measuring systems for loading ships

> measuring systems for refuelling aircraft

1,0

> Measuring systems (other than LPG dispensers) for liquefied gases under pressure

measured at a temperature equal to or above - 10 MC

> LPG dispensers for motor vehicles

> Measuring systems normally in class 0,3 or 0,5 but used for liquids

> whose temperature is less than - 10 MC or greater than 50 MC

> whose dynamic viscosity is higher than 1 000 mPa.s

> whose maximum volumetric flowrate is not higher than 20 L/h

1,5

Measuring systems for liquefied carbon dioxide

Measuring systems (other than LPG dispensers)
measured at a temperature below - 10 MC (other than cryogenic liquids).

for liquefied gases under pressure

2,5

Measuring systems for cryogenic liquids (temperature below - 153 MC)

10.

UNITS OF MEASUREMENT

Metered quantity shall be displayed in millilitres (ml) or cubic centimetres (cm3), litres (l or L), cubic metres (m3),
grams (g), kilograms (kg) or tonnes (t).

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are:

For mechanical or electromechanical systems: B+F, B+E, B+D, H1, G.

For electronic systems or systems containing software: B+F, B+D, H1, G.

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ANNEX MI-006

AUTOMATIC WEIGHING INSTRUMENTS

The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment
procedures listed in the different chapters of this Annex apply to automatic weighing instruments defined below
intended to determine the mass of a body by using the action of gravity on that body.

DEFINITIONS

Automatic weighing instrument

An instrument that determines the mass of a product without the intervention of an operator and follows a prede-
termined programme of automatic processes characteristic of the instrument.

Automatic catchweigher

An automatic weighing instrument that determines the mass of pre-assembled discrete loads or single loads of loose
material.

Automatic checkweigher

An automatic catchweigher that subdivides articles of different mass into two or more subgroups according to the value
of the difference of their mass and a nominal set-point.

Weightgrader

An automatic catchweigher that subdivides articles of different mass into several subgroups each characterised by a
given mass range.

Weigh labeller/price labeller

An automatic catchweigher that labels/prices and labels individual articles.

Automatic gravimetric filling instrument

An automatic weighing instrument that fills containers with a predetermined and virtually constant mass of product
from bulk and which comprises essentially an automatic feeding device or devices associated with one or more weighing
units and the appropriate control and discharge devices.

Discontinuous totalizer (totalizing hopper weigher)

An automatic weighing instrument that determines the mass of a bulk product by dividing it into discrete loads. The
mass of each discrete load is determined in sequence and summed. Each discrete load is then delivered to bulk.

Continuous totalizer

An automatic weighing instrument that continuously determines the mass of a bulk product on a conveyor belt, without
systematic subdivision of the product and without interrupting the movement of the conveyor belt.

Rail-weighbridge

An automatic weighing instrument having a load receptor inclusive of rails for conveying railway vehicles.

SPECIFIC REQUIREMENTS

CHAPTER I > REQUIREMENTS COMMON TO ONE OR MORE AUTOMATIC WEIGHING INSTRUMENTS

1.1.

Rated operating conditions

The manufacturer shall specify the rated operating conditions for the instrument, in particular, values shall be
specified for the following operating conditions:

(i) measurement range of the instrument in terms of its maximum and minimum capacity,

(ii) power supply; nominal AC supply voltage and/or limits of DC supply,

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(iii) the climatic and mechanical environment class B, C or I in which the instrument or its sub-assemblies are
intended to be used in accordance with Table 1 of Annex I, and observing the following conditions for
temperature range:

> minimum range of 50 MC for classes C and I

> minimum range of 30 MC for class B

1.2. Manufacturer’s specification

The manufacturer shall also specify:

(i) rate of operation,

(ii) where appropriate for the intended use of the instrument, the characteristics of the product to be weighed,

such as:

> temperature,

> particle size,

> bulk density,

> viscosity

> or any other defining characteristic.

2.

Electromagnetic environment

In accordance with requirement 1.3.2 of Annex I the manufacturer shall specify in which electromagnetic
environment Class E1 or Class E2 the instrument is intended to be used.

The permitted performance and the critical change value are given in the relevant Chapter for each type of
instrument.

3.

Suitability

3.1.

3.2.

Means shall be provided to limit the effects of tilt, loading and rate of operation such that maximum permissible
errors are not exceeded in normal operation.

Adequate material handling facilities shall be provided to enable the instrument to respect the maximum
permissible errors during normal operation.

3.3.

If present, the operator control interface shall be clear and effective.

3.4.

The integrity of the display shall be verifiable by the operator.

3.5.

Adequate zero setting capability shall be provided to enable the instrument to respect the maximum permissible
errors during normal operation.

3.6.

Printout

A processed printing of results outside the measurement range shall be identified as such.

CHAPTER II > AUTOMATIC CATCHWEIGHERS

1.

Accuracy classes

Instruments are divided into accuracy classes designated by:

X(x) or Y(y)

1.1.

Class X(x)

Class X(x) applies to instruments used to check prepackages made up in accordance with the requirements of
directives 75/106/EEC and 76/211/EEC as amended.

X is a regime relating accuracy to load weight and the class designation factor (x) is a multiplier for the limits of
error specified for class X(1).

The manufacturer shall specify the class designation factor (x). (x) shall be 1 H 10k, 2 H 10k or 5 H 10k, where k is
an integer or zero.

1.2.

Class Y(y)

Class Y(y) applies to all other automatic catchweighers. Class Y has two sub-classes Y(a) or Y(b).

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2.

Maximum permissible error

2.1.

Class X(x) instruments

2.1.1. Mean error

Load (m) in verification scale intervals (e)
(x) £ 1 (x) > 1

Maximum permissible mean error

0 < m £ 500

500 < m £ 2 000

0 < m £ 50

50 < m £ 200

2 000 < m £ 10 000

200 < m £ 1 000

– 0,5 e

– 1,0 e

– 1,5 e

2.1.2. Standard deviation

Load (m)

m £ 50 g

50 < m £ 100

100 g < m £ 200 g

200 g < m £ 300 g

300 g < m £ 500 g

500 g < m £ 1 000 g

1 000 g < m £ 10 000 g

10 000 g < m £ 15 000 g

15 000 g < m

Maximum permissible standard deviation for class X(1)

0,48 %

0,24 g

0,24 %

0,48 g

0,16 %

0,8 g

0,08 %

8 g

0,053 %

2.2.

Class Y(y) instruments

Net load (m) in verification scale intervals (e)
Class Y(a) Class Y(b)

Maximum permissible error

0 < m £ 500

500 < m £ 2 000

0 < m £ 50

50 < m £ 200

2 000 < m £ 10 00

200 < m £ 1 000

– 1,5 e

– 2,0 e

– 2,5 e

3.

Measurement range

In specifying the measurement range for class Y(y) instruments the manufacturer shall take account that the
minimum capacity shall not be less than:

> 20 e for class Y(a)

> 10 e for class Y(b)

> 5 e for postal scales of class Y(a) or Y(b)

4.

Dynamic setting

When fitted, a dynamic setting facility that compensates for the dynamic effects of the load in motion:

> shall be inhibited to operate outside the specified load range, and

> shall be capable of being secured.

The dynamic setting facility shall operate over a load range specified by the manufacturer.

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5.

Performance under electromagnetic disturbances

The critical change value due to a disturbance is one scale interval.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are:

For mechanical or electromechanical instruments: F1, E1, D1, B+F, B+E, B+D, H, G.

For electronic instruments or instruments containing software: B+F, B+D, H1, G.

CHAPTER III > AUTOMATIC GRAVIMETRIC FILLING INSTRUMENTS

1.

1.1.

Accuracy classes

An instrument type is designated a reference accuracy class, Ref(x), corresponding to the best possible accuracy
for instruments of the type. After installation individual instruments are designated for one or more operational
accuracy classes, X(x), having taken account of the specific products to be weighed. The class designation factor
(x) shall be in the form 1 H 10k, 2 H 10k or 5 H 10k, the index k being any integer or zero.

The manufacturer shall specify both the reference accuracy class Ref(x) and the operational accuracy class(es),
X(x).

1.2.

Reference accuracy class

The reference accuracy class, Ref(x), is applicable for static weighing for which the maximum permissible error
shall be as given in 2.2 multiplied by the class designation factor (x).

1.3.

Operational accuracy class

For the operational accuracy class X(x), X is a regime relating accuracy to load weight and (x) is a multiplier for
the limits of error specified for class X(1) in 2.2.

2.

Maximum permissible error

2.1.

Maximum permissible static weighing error

For static loads under rated operating conditions, the maximum permissible error for reference accuracy class
Ref(x), shall be 0,36 of the maximum permissible deviation of each fill from the average as specified in 2.2.

2.2.

Deviation from average fill

Value of the mass of the fills > M(g)

Maximum permissible deviation of each fill from the average for class X(1)

M £ 50

50 < M £ 100

100 < M £ 200

200 < M £ 300

300 < M £ 500

500 < M £ 1 000

1 000 < M £ 10 000

10 000 < M £ 15 000

15 000 < M

6,3 %

3,15 g

3,15 %

6,3 g

2,1 %

10,5 g

1,05 %

105 g

0,7 %

Note: Maximum deviation of each fill from the average may be adjusted in the case of a positive error to account for the effect of
material particle size.

2.3. Maximum permissible error relative to pre-set value (setting error)

For instruments where it is possible to pre-set a fill weight the maximum difference between the pre-set value
and the average mass of the fills shall not exceed 0,36 of the maximum permissible deviation of each fill from
the average, as specified in 2.2.

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3.

Performance under electromagnetic disturbance

The critical change value is equal to a change of static weight indication equal to the maximum permissible error
as specified in 2.1 calculated for the rated minimum fill, or a change that would give equivalent effect on the fill
in the case of instruments where the fill consists of multiple loads.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are:

For mechanical or electromechanical instruments: B+F, B+E, B+D, H1, G.

For electronic instruments or instruments containing software: B+F, B+D, H1, G.

CHAPTER IV > DISCONTINUOUS TOTALIZERS

1.

Maximum permissible error

Accuracy class

Maximum permissible error of totalized load

0,2

0,5

1

2

– 0,10 %

– 0,25 %

– 0,50 %

– 1,00 %

2.1.

Totalization scale interval (dt) shall be in the range:
0,01 % max < dt < 0.2 % max.

2.2. Minimum totalized load ((cid:5)min) shall be greater than the load at which the maximum permissible error is equal to

the totalization scale interval (dt) and greater than the minimum load.
Zero setting

2.3.

Instruments that do not tare weigh after each discharge shall have a zero setting device and automatic operation
shall be inhibited if zero indication > 0,5 d.

2.4.

Operator interface

Operator adjustments and reset function shall be inhibited during automatic operation.

2.5.

Printout

On instruments equipped with a printing device, the reset total shall be inhibited until the total is printed. The
printout of total shall occur if automatic operation is interrupted.

3.

Performance under electromagnetic disturbances

The critical change value due to a disturbance is:

(a) one scale interval of weight indication; or

(b) one totalization scale interval for any stored total.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are:

For mechanical or electromechanical instruments: B+F, B+E, B+D, H1, G.

For electronic instruments or instruments containing software: B+F, B+D, H1, G.

CHAPTER V > CONTINUOUS TOTALIZERS

1.

Measurement range

In specifying the measurement range the manufacturer shall take account that:

(i) The minimum instantaneous net load on the weighing unit shall not be less than 20 % of the maximum

capacity.

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(ii) The minimum totalized load (cid:5)min shall not be less than the largest of the following values:

> 2 % of the load totalized in one hour at maximum flowrate;

> the load obtained at maximum flowrate in one revolution of the belt;

> the load corresponding to the following appropriate number of totalization scale intervals,

800 e for class 0.5

400 e for class 1

200 e for class 2.

2.

Maximum permissible error

Accuracy class

Percentage of the mass of the totalized load

0,5

1

2

3.

Speed of the belt

0,25

0,5

1,0

4.

5.

The speed of the belt shall be specified by the manufacturer. The speed shall not vary by more than 5 % of the
nominal value. The product shall not have a different speed than the speed of the belt.

It shall not be possible for the general totalization device to be reset to zero.

Performance under electromagnetic disturbances

The critical change value due to a disturbance is 0,7 mpe.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are:

For mechanical or electromechanical instruments: B+F, B+E, B+D, H1, G.

For electronic instruments or instruments containing software: B+F, B+D, H1, G.

CHAPTER VI > AUTOMATIC RAIL WEIGHBRIDGES

1.

Maximum permissible error

Accuracy class

Percentage of mass of single wagon or total train, as appropriate

0,2

0,5

1

2

0,1

0,25

0,5

1,0

When weighing coupled wagons the errors of not more than 10 % of the weighing results taken from one or
more passes of the train may exceed the appropriate maximum permissible error given in the above Table but
shall not exceed twice that value.

The scale interval shall not be greater than one tenth of the initial MPE applied to the minimum
capacity.

Performance under electromagnetic disturbance

The critical change value is one verification scale interval.

2.

3.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are:

For mechanical or electromechanical instruments: B+F, B+E, B+D, H1, G.

For electronic instruments or instruments containing software: B+F, B+D, H1, G.

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ANNEX MI-007

TAXIMETERS

the specific requirements of
The relevant requirements of Annex I,
procedures listed in this Annex apply to taximeters installed in a taxi.

this Annex and the conformity assessment

DEFINITIONS

A taximeter is a measuring instrument designed for installation in a motor vehicle that calculates and displays the fare to
be paid for a trip, based on the distance travelled and the duration of the trip.

SPECIFIC REQUIREMENTS

Design requirements

1.

A taximeter shall be designed to measure the following parameters:

(a) the distance travelled;

(b) the duration;

(c) the period of time during which the speed of the car was below a certain threshold value. This threshold

value of the speed shall be adjustable and it shall be possible to secure the adjustment.

2.

In addition to the devices necessary to carry out the measurements referred to in requirement 1, a taximeter shall
comprise the following auxiliary devices:

> a printer interface or built-in printer;

> a real time clock;

> a device for data exchange to a central device.

It shall be possible to disable the functioning of any of these auxiliary devices and to secure the disablement.

3.

A taximeter shall be able to calculate the fare in both of the following manners:

1. on the basis of parameters (a) and (b) of requirement 1;

2. on the basis of parameters (a) and (c) of requirement 1.

It shall be possible to disable the functioning of any of these two modes of calculation and to secure the
disablement.

4.

It shall be possible to adjust a taximeter for the vehicle constant of the taxi in which it is to be installed and to
secure the adjustment.

Rated operating conditions

5.

The manufacturer shall specify the rated operating conditions for the instrument, in particular:

> the climatic and mechanical environment class D, E or F in which the instrument is intended to be used in

accordance with Table 1 of Annex I;

> the limits of the DC power supply for which the instrument has been designed.

Maximum permissible errors

6.

The maximum permissible errors are:

> For the time elapsed: – 0,1 %;

> For the distance travelled: – 0,2 %;

> For the calculation of the fare: – 0,1 %.

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Permissible effect of disturbances

7.1.

Electromagnetic immunity.

7.1.1. The electromagnetic class that applies is E2 in accordance with point 1.3.2. of Annex I.

7.1.2. The maximum permissible errors laid down in requirement 6 shall also be respected in the presence of an

electromagnetic disturbance.

Power supply failure

8.

In case of a reduction of the DC voltage supply to a value below the lower operating limit as specified by the
manufacturer, the taximeter shall either

> save and display the value of the fare at the moment the power supply failure took place, and return to the

position Afor hireB, or

> preserve its measuring functions and continue to meet the maximum permissible errors until it saves and

displays the value of the fare and returns to the position Afor hireB.

Other requirements

9.1.

A taximeter shall permanently display the fare in real-time.

9.2.

10.

If the fare includes a fixed sum, this shall be excluded from the fare displayed. However, in that case a taximeter
may display temporarily the value of the fare inclusive of the fixed sum.

If the fare is calculated according to method 1 of requirement 3, a taximeter may have an additional display
mode in which only distance travelled and duration of the trip are displayed in real time.

11.

All values displayed for the passenger shall be clearly readable under daylight and night conditions.

12.

If the fare to be paid can be effected by the choice of functionality from a pre-programmed set or by free data
setting, it shall be possible to secure the instrument settings and data entered.

13.

A taximeter shall be fitted with totalizers for all of the following values:

> the values of the parameters listed in requirement 1;

> the values of the fare.

The totalized values shall include the values saved according to requirement 8 under conditions of loss of power
supply.

If disconnected from power, a taximeter shall retain the totalized values during at least six months.

14.

It shall be impossible to change the tariff, tariff structure or mode of calculation of the fare with the taximeter in
operation, other than automatic changes by the meter itself on the basis of

> the parameters listed in requirement 1; or

> the time of the day and day of the week if the taximeter is fitted with a real time clock.

15.

It shall be possible to secure the connection of the taximeter to the taxi in which it is installed.

16.

17.

18.

It shall be possible to verify the compliance of a taximeter installed in a taxi with the requirements on maximum
permissible error.

installed
A taximeter and its installation instructions specified by the manufacturer shall be such that,
according to the manufacturer’s instructions, fraudulent alterations of the measurement signal representing
the distance travelled are impossible.

if

A taximeter shall be designed so that it can respect the maximum permissible errors without adjustment during
a period of 1 year of normal use.

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19.

For the auxiliary devices listed in requirement 2 whose functioning has not been disabled and secured as part of
the conformity assessment, the following additional requirements apply:

for the printer interface or built-in printer:

> the functioning of the taximeter shall be inhibited when no printer is connected or when printing is

impossible for other reasons;

for the real time clock:

> the possibility to adjust the time of the day shall be limited to 2 minutes per week. Adjustment to summer

and winter time shall be automatic;

for the data exchange device:

> transfer to a central system of data that are subject to legal control by this Directive shall only be possible if

the taximeter protects the data against accidental or deliberate interference during the transfer;

> transfer from a central system of data that are subject to legal control by this Directive is subject to the

following requirements:

> it shall be easily possible to check the correct reception of the data by the taximeter;

> the taximeter shall transmit evidence of correct data reception to the central system.

20.

The values of distance travelled and time elapsed, when displayed or printed in accordance with this Directive,
shall use the following units:

distance travelled:

> in the United Kingdom and Ireland: until the date which will be fixed by these Member States according to
Article (1)(b) of Directive 80/181/EEC, as last amended by Directive 89/617/EEC: kilometres or miles;

> in all other Member States: kilometres.

Time elapsed:

minutes.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: B+F, B+D, H1.

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ANNEX MI-008

MATERIAL MEASURES

CHAPTER I > MATERIAL MEASURES OF LENGTH

The relevant essential requirements of Annex I, the specific requirements of this chapter and the conformity assessment
procedures listed in this chapter apply to material measure of length defined below.

DEFINITIONS

Material measure of length

An instrument whose scale marks determine the length of a measured object by direct comparison.

SPECIFIC REQUIREMENTS

Reference conditions

1.1.

For tapes of length equal to or greater than five metres, the maximum permissible errors are to be respected
with a tractive force of twenty Newtons, unless otherwise specified by the manufacturer and marked accordingly.

1.2.

The reference temperature is 20 MC unless otherwise specified by the manufacturer and marked accordingly.

Maximum permissible errors

2.

The maximum permissible error, positive or negative, between two non-consecutive scale marks is L = a + bL,
where:

> L is the value of the length rounded up to the next whole metre; and

> a and b are given in Table 1 below.

When a terminal interval is bounded by a surface, the maximum permissible error for any distance beginning at
this point is increased by the value c given in Table 1 below.

Accuracy class

a (mm)

Table 1

I

II

III

0,1

0,3

0,6

b

1,10-4

2,10-4

4,10-4

c (mm)

0,1

0,2

0,4

The maximum permissible error for the length of two consecutive scale marks, and the maximum permissible
difference between two consecutive intervals are given in Table 2 below.

Length i of the interval

i £ 1 mm

1 mm < i £ 1 cm

1 cm < i £ 1 dm

Table 2

Maximum permissible error or difference in millimetres according to accuracy class

I

0,1

0,2

0,3

II

0,2

0,4

0,5

III

0,3

0,6

0,9

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Materials

3.1.

3.2.

Materials used for material measures of
permissible error can be respected in a range of – 8 K.

length shall have such a temperature stability that the maximum

The materials used for material measures of
permissible error can be respected up to 85 % relative humidity.

length shall have such humidity stability that the maximum

Markings

4.

The scale marks shall bear the value of length.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: A1, F1, E1, D1, B+E, B+D, H, G.

CHAPTER II - CAPACITY SERVING MEASURES

The relevant essential requirements of Annex I, the specific requirements of this chapter and the conformity assessment
procedures listed in this chapter apply to capacity serving measures defined below.

DEFINITIONS

Capacity serving measure

A capacity measure intended to determine a specified volume of a liquid which is sold for immediate consumption.

Line measure

A capacity serving measure having a mark to indicate nominal capacity.

Brim measure

A capacity serving measure for which the internal volume is equal to the nominal capacity.

Transfer measure

A capacity serving measure from which it is intended that the liquid is decanted prior to consumption.

Capacity

The capacity is the internal volume for brim measures or internal volume to a filling mark for line measures.

SPECIFIC REQUIREMENTS

Reference conditions

1.1.

Temperature: the reference temperature for measurement of capacity is 20 MC.

1.2.

Position for correct indication: free standing on a level surface.

2.

Maximum permissible errors

Table 1

Transfer measures

Line measures < 200 ml

Line measures ‡ 200 ml

Brim measures < 200 ml

Brim measures ‡ 200 ml

– 3 %

– 5 %

– 3 %

0 to 10 %

0 to 6 %

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Materials

3.

Capacity serving measures shall be made of material which is sufficiently rigid and dimensionally stable to
maintain capacity within the maximum permissible error.

Shape

4.1.

4.2.

Transfer measures shall be designed so that a change of contents equal to the maximum permissible error causes
a change in level of 2 mm at the brim or filling mark.

Transfer measures shall be designed so that the complete discharge of the liquid being measured will not be
impeded.

Marking

5.1.

The nominal capacity declared shall be clearly and indelibly marked on the measure.

5.2.

Capacity serving measures may also be marked with up to three clearly distinguishable capacities, none of which
shall lead to confusion one to the other. A further half-capacity filling mark associated with one of the marked
capacities is allowed provided it does not cause confusion.

5.3.

All filling marks shall be sufficiently clear and durable to ensure that maximum permissible errors are not
exceeded in use.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: A1, F1, E1, D1, B+E, B+D, H.

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ANNEX MI-009

DIMENSIONAL MEASURING INSTRUMENTS

The applicable essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment
procedures listed in this Annex apply to dimensional measuring instruments of the types defined.

DEFINITIONS

Length measuring instrument

A length measuring instrument serves for the automatic determination of the length of materials in the form of bands
and cables during feed motion of the product to be measured.

Area measuring instruments

An area measuring instrument serves for the automatic determination of the area of irregular shaped objects, e.g. for
leather.

Multi-dimensional measuring instruments

A multi-dimensional measuring instrument serves for the automatic determination of the edge length (length, hight,
width) of the smallest enclosing rectangular parallelepiped of a product.

CHAPTER I > REQUIREMENTS COMMON TO ALL DIMENSIONAL MEASURING INSTRUMENTS

Mechanical and climatic environment

1.

The manufacturer shall specify in which climatic and mechanical environment class the instrument is intended to
be used in accordance with Table 1 of Annex I.

Electromagnetic immunity

2.1.

The manufacturer shall specify the electromagnetic environment E1 or E2 in which the instrument is intended to
be used in accordance with requirement 1.3.2 of Annex I.

2.2.

The effect of an electromagnetic disturbance on a dimensional measuring instrument shall be such that:

> the change in measurement result is no greater than the critical change value as defined in 2.3; or

> it is impossible to perform any measurement; or

> there are momentary variations in the measurement result that cannot be interpreted, memorised or trans-

mitted as a measuring result; or

> there are variations in the measurement result severe enough to be noticed by all those interested in the

measurement result.

2.3.

The critical change value is equal to one scale interval.

Durability

3.

An instrument must be designed so that it can respect twice the maximum permissible error without adjustment,
during a period of one year in normal use.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are:

For mechanical or electromechanical instruments: F1, E1, D1, B+E, B+D, H, G.

For electronic instruments or instruments containing software: B+F, B+D, H1, G.

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27.2.2001

CHAPTER II > LENGTH MEASURING INSTRUMENTS

Characteristics of the product to be measured

1.

Textiles are characterised by the characteristic factor K. This factor takes the stretchability and force per unit area
of the product measured into account and is defined by the following formula:

K = (cid:6)(GA + 2.2 N/m2), where

(cid:6) is the relative elongation of a cloth specimen 1 m wide at a tensile force of 10 N,

GA is the weight force per unit area of a cloth specimen in N/m2.

Operating conditions

2.1.

Range

Dimensions and K-factor, where applicable, within the range specified by the manufacturer for the instrument.
The ranges of K-factor are as given in Table 1:

Table 1

Group

Range of K

I

II

III

IV

0 < K < 2,10-2 N/m2

2,10-2 N/m2 < K < 8,10-2 N/m2

8,10-2 N/m2 < K < 24,10-2 N/m2

24,10-2 N/m2 < K

Product

low stretchability

medium stretchability

high stretchability

very high stretchability

2.2. Where the measured object is not transported by the measuring instrument, its speed must be within the range

specified by the manufacturer for the instrument.

2.3.

If the measurement result depends on the thickness, the surface condition and the kind of delivery (e.g. from a
big roll or from a pile), corresponding limitations are specified by the manufacturer.

Maximum permissible errors

3.1.

Instrument

Table 2

Accuracy class

Maximum permissible error

I

II

III

0,125 %

0,25 %

0,5 %

However, the maximum permissible absolute error cannot be less than the values given below:

Class I:

0,005 Lm

Class II:

0,01 Lm

Class III: 0,02 Lm

Where Lm is the minimum measurable length, that is to say the smallest length specified by the manufacturer for
which the instrument is intended to be used.

Other requirements

4.1.

The instruments must ensure that the product is measured unstretched according to the intended stretchability
for which the instrument is designed.

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CHAPTER III > AREA MEASURING INSTRUMENTS

Operating conditions

1.1.

Range

Dimensions within the range specified by the manufacturer for the instrument.

1.2.

Condition of the product

The manufacturer shall specify the limitations of the instruments due to the speed, and thickness of the surface
conditions if relevant, of the product.

Maximum permissible errors

2.1.

Instrument

The initial MPE is – 1,0 %, but not less than 1 dm2.

Other requirements

3.

Presentation of the product

In the case of pulling back or stopping the product it should not be possible to have an error of measurement or
the display must be blanked.

4.

Scale interval

The instruments must have a scale interval of 1,0 dm2. In addition, it must be possible to have a scale interval of
0,1 dm2 for testing purposes.

CHAPTER IV > MULTIDIMENSIONAL MEASURING INSTRUMENTS

Operating conditions

1.1.

The range shall be one of the following:

> 0,5 cm to 5,0 cm;

> 1,0 cm to 80 cm;

> 5 cm to 2 m;

> 50 cm to 20 m.

1.2.

Speed of the product

The speed must be within the range specified by the manufacturer for the instrument.

Maximum permissible error

2.1.

Instrument:

Range

0,5 cm-5,0 cm

1,0 cm-80 cm

5 cm-200 cm

50 cm-2 000 cm

Table 1

Maximum permissible error

0,1 cm

0,2 cm

1,0 cm

10 cm

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27.2.2001

ANNEX MI-010

EVIDENTIAL BREATH ANALYSERS

The relevant requirements of Annex I,
procedures listed in this Annex apply to evidential breath analysers defined below.

the specific requirements of

this Annex and the conformity assessment

DEFINITIONS

An evidential breath analyser is a measuring instrument that serves to determine the concentration of ethanol in exhaled
alveolar air and that is intended for use for evidential purposes.

SPECIFIC REQUIREMENTS

Rated operating conditions

1.

The rated values of the operating conditions shall be specified by the manufacturer as follows:

1.1.

For the measurand:

> The measuring range, subject to the following constraint:

> The measuring range shall extend from 0 mg/l to at least 1,5 mg/l.

1.2.

For the condition of the exhaled air:

> Volume range: 1.5-4.5 l;

> Duration of exhalation: 5-15 s.

1.3.

For the climatic and mechanical influence quantities:

> For a non-portable instrument, the environment class that applies is class E;

> For a portable instrument, the environment class that applies is class I.

1.4.

For the electrical supply influence quantities:

> In case of AC voltage supply: The voltage range, subject to the following constraints:

> The minimum value of the voltage range shall be £ nominal value O 8 %;

> The maximum value of the voltage range shall be ‡ nominal value + 24 %.

> In case of DC voltage supply:

> The limits of the DC voltage supply.

1.5.

For the ambient pressure:

> The minimum and maximum values of the ambient pressure, subject to the following restrictions:

> Min £ 800 hPa

> Max ‡ 1 040 hPa

Maximum permissible error

2.

The maximum error values permitted under rated operating conditions according to requirement 3.1 of Annex I
are as shown in Table 1. Percentage values are percent of the true value.

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True value (mg/l)

Maximum permitted error

Table 1

< 0,4

‡ 0,4
£ 2

> 2

0,02 mg/l

– 5 %

– 20 %

3.

The verification scale interval = 0,001 mg/l.

PERMISSIBLE EFFECT OF DISTURBANCES

Electromagnetic immunity

4.

5.

The manufacturer shall specify the electromagnetic environment E1 or E2 in which the measuring instrument is
intended to be used in accordance with requirement 1.3.2 of Annex I.

The effect of an electromagnetic disturbance shall be such that:

(a) the change in measurement result is no greater than the maximum permissible error of the measurement

result, or

(b) the measurement result presented cannot be interpreted as a valid result in that:

> the carrying out of any measurement is impossible, or

> there are momentary variations in the measurement result that cannot be interpreted, memorised or

transmitted as a measurement result, or

> there are variations in the measurement result severe enough to be noticed by all those interested in the

measurement result.

Durability

6.

An evidential breath analyser shall be designed so that it can respect 1.6 times the maximum permissible error
without adjustment during a period of 2 years after its first putting into use.

Other requirements

7.

8.

9.

10.

11.

An evidential breath analyser shall indicate the measurement result in mg/l.

For any concentration up to 0,4 mg/l, the standard deviation of the results of 10 measurements shall be less
than 0,007 mg/l.

For any concentration equal to or greater than 0,4 mg/l and less than or equal to 2 mg/l, the standard deviation
of the results of 10 measurements shall be less than 1,75 %.

For any concentration greater than 2 mg/l, the standard deviation of the results of 10 measurements shall be less
than 6 %.

An evidential breath analyser shall only carry out a measurement if the sample taken is recognised as being
representative of the alveolar air. It shall in particular inhibit a measurement if the exhalation was discontinuous,
or if the exhaled air contained breath from the upper respiratory tracts.

Before each measurement operation, the evidential breath analyser shall verify automatically that it is capable of
carrying out a correct measurement, and shall in particular carry out an automatic adjustment. In case this
automatic verification shows that not all conditions for correct operation are fulfilled, any measurement shall be
automatically inhibited.

It shall be possible for the user to pre-set a numerical value in the evidential breath analyser. After each
measurement with a result greater than this pre-set value, the analyser shall automatically, and before presenting
the measurement result, repeat the verification referred to in requirement 10. In case this second verification
shows that not all conditions for correct operation are fulfilled, no measurement result shall be presented.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: B+F, H1, G.

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Official Journal of the European Communities

27.2.2001

ANNEX MI-011

EXHAUST GAS ANALYSERS

this Annex and the conformity assessment
The relevant requirements of Annex I,
procedures listed in this Annex apply to exhaust gas analysers defined below intended for inspection and professional
maintenance of motor vehicles in use.

the specific requirements of

DEFINITIONS

An exhaust gas analyser is a measuring instrument that serves to determine all of the volume fractions of the following
components of the exhaust gas of a motor vehicle engine with spark ignition: carbon monoxide, carbon dioxide,
hydrocarbons and oxygen.

An exhaust gas analyser may determine in addition the value of the parameter º.

SPECIFIC REQUIREMENTS

Instrument classes

1.

Two instrument classes I and II are being defined for exhaust gas analysers, the measurement ranges for these
classes being as shown in Table 1.

Parameter

CO fraction (%v/v)

CO2 fraction (%v/v)

Hydrocarbon fraction (%v/v)

O2 fraction (%v/v)

º

Table 1

Classes and measurement ranges

Class I

Class II

Min

0

0

0

0

£ 0,8

Max

‡ 5
< 7

‡ 16

‡ 0,2

‡ 21

‡ 1,2

Min

0

0

0

0

£ 0,8

Max

‡ 7

‡ 16

‡ 0,2

‡ 21

‡ 1,2

Rated operating conditions

2.

The rated values of the operating conditions shall be specified by the manufacturer as follows:

2.1.

For the climatic and mechanical influence quantities:

> The environment class that applies is class B, in accordance with Table 1 of Annex I.

2.2.

For the electrical power influence quantities:

> The voltage and frequency range for the AC voltage supply;

> The limits of the DC voltage supply.

2.3.

For the ambient pressure:

> The minimum and maximum values of the ambient pressure, subject to the following restrictions:

Class I

Class II

pmin

860 hPa

800 hPa

pmax

1 060 hPa

1 040 hPa

2.4.

For the concentration of residue hydrocarbon present before a measurement:

The maximum value of the concentration, subject to the following constraint: For a class I instrument, this value
shall be no greater than 20 ppm v/v.

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Maximum permissible errors

3.

For each of the fractions measured, the maximum error value permitted under rated operating conditions
according to requirement 1.1 of Annex I is the smaller of the two values shown in Table 2. Absolute values
are expressed in %v/v or ppm v/v, percentage values are percent of the true value.

Table 2

Maximum permissible errors

Class I

– 0,06 %v/v
– 5 %

– 0,5 %v/v
– 5 %

– 12 ppm v/v
– 5 %

– 0,1 %v/v
– 5 %

– 0,3 %

Class II

– 0,2 %v/v
– 10 %

– 1 %v/v
– 10 %

– 30 ppm v/v
– 10 %

– 0,2 %v/v
– 10 %

– 0,3 %

Parameter

CO fraction

CO2 fraction

Hydrocarbon fraction

O2 fraction

¸

Permissible effect of disturbances

4.

Electromagnetic immunity

The manufacturer shall specify the electromagnetic environment E1 or E2 in which the instrument is intended to
be used in accordance with requirement 1.3.2 of Annex I.

The effect of an electromagnetic disturbance shall be such that:

> either the change in the measurement result is no greater than the critical change value laid down in point

4.1.3,

> or the presentation of the measurement result is such that it cannot be taken for a valid result.

For each of the volume fractions measured by the instrument, the critical change value is equal to the maximum
permissible error for the parameter concerned.

Other requirements

5.

The maximum permitted scale intervals for each of the two instrument classes are as shown in Table 3:

Parameter

CO fraction

CO2 fraction

Hydrocarbon fraction

O2 fraction

º

Table 3

Maximum permitted scale intervals

Class I

0,01 %v/v

0,1 %v/v

1 ppm v/v

0,02 %v/v if O2 £ 4 %v/v
0,10 %v/v if O2 > 4 %v/v

0,01

Class II

0,05 %v/v

0,1 %v/v

5 ppm v/v

0,1 %v/v

0,01

6.

7.

The standard deviation of 20 measurements shall not exceed mpe/3.

The indications of the measurement results shall have reached 95 % of the final values in no more than 15 s.

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8.

The components in the exhaust gas other than the component whose value is subject to measurement shall not
affect the measurement result by more than 0.5 mpe, when those components are present in the following
volume fractions:

CO £ 6 %v/v

CO2 £ 16 %v/v

O2 £ 10 %v/v

H2 £ 5 %v/v

NO £ 0,3 %v/v

HC £ 2 000 ppm v/v

Water vapour: any value.

9.

10.

An exhaust gas analyser that is equipped with an automatic or semi-automatic adjustment facility shall be unable
to make a measurement as long as the adjustments have not been made.

An exhaust gas analyser with a hydrocarbon channel shall detect hydrocarbon residues in the gas handling
system. It shall be impossible to carry out a measurement if the concentration of the residue hydrocarbon
present before a measurement exceeds the rated value as specified by the manufacturer according to requirement
2.6 of this Annex.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 7 are: B+F, B+D, H1.