Proposal for a COUNCIL DIRECTIVE on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres
Date: 1991-12-13
Institutions: European Commission
Subjects: EU trade mark, drilling equipment, explosive, harmonisation of standards, product safety

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

C0M(91)516  final  - SYN 375 

Brussels, 13  December 1991 

Proposal  for a 

COUNCIL DIRECTIVE 

on the approximation of the laws 

of the Member States concerning equipment 

and proteotive systems intended for use 

in potentially explosive atmospheres 

(presented by the Commission) 

- 2 -

I. 

General 

i. Aim of the proposal 

a.  Regulatory aspects 

This  proposal  for  a  directive  is  intended  to  replace  Directives 
76/117/EEC  and  79/196/EEC  (surface  equipment)  and  Ô2/130/EBC 
(mining  equipment),  together  with  their  subsequent  amendments 
84/47/EEC,  88/571/EEC,  90/487/EEC,  88/35/EEC  and  91/269/EEC. 

There  were,  indeed,  certain  difficulties  in  Implementing  those 
directives, which only incorporated  an intermediate  stage for the 
treatment of equipment that could be used in potentially explosive 
atmospheres: 

-  the harmonization  introduced  was  only  of  the  "optional"  type, 
thus  enabling  the  Member States  to  majTvha.in  a  legal  system 
parallel  to  that  introduced  by  the  directives.  This  only 
ensured  the  free  movement  of  equipment  complying  with  it. 
Nevertheless, when directive 79/196/EEC was adopted the Council 
asked  the  Commission during  a  subsequent  stage,  to  study  the 
scope for achieving total harmonization and to sent it proposals 
with  that  in  mind  (cf.  declaration  set  out  in  the  minute, 
31 January 1979); 
Document 

4336/79 

of 

-  the scope of the existing directives is restricted to electrical 
equipment and, in the case of surface equipment, is governed by 
the  use  of  certain  specific  types  of  protection.  This  was 
correct practice in 1979 but it has been unable to take account 
of major  technological  change and  recent discoveries  regarding 
physical  sources  and  phenomena  relating  to  ignition.  Certain 
risks  had  either  not  been  encountered  or  were  considered 
harmless  and  only  emerged  through  experience  or  detailed 
research. 

- 3 

the technical annex to the directives is a direct reference to 
the  CENELBC  standards,  thus  requiring  the  long,  complicated 
procedure required by the Committee on Adaptation to Technical 
Progress.  This means  that  several years  often  elapse between 
adaptation of the content of the standards by CENELBC and their 
harmonization  via  a  Commission  directive.  Manufacturers 
therefore 
after 
only 
disproportionately long delays. 

movement 

benefit 

free 

from 

a  particular  problem  arises  from  the  separate  treatment  of 
surface  and  mining  equipment  in  separate  directives.  It 
therefore  becomes  difficult  to  synchronize  adaptation  to 
technical progress procedures for the two groups of equipment, 
especially  since  the  respective  cxanmittees  are  completely 
different (ministries for industry as :regards surface equipment, 
closed committee within the Safety and Health Commission for the 
Mining  and  other  Extractive  Industries).  It  must  also  be 
pointed  out  that  the  CENELEC  standards  relating  to  mining 
equipment have undergone amendments of varying scope in the form 
of  a  technical  annex  to  Directive 83/130/EEC.  The  specific 
features of  the two groups of often very similar or identical 
forms of equipment could no longer, however, Justify their being 
dealt with in two separate categories? of directive and can be 
subjected to the basic requirements and the typical conformity 
certification procedures by means of equipment categories within 
that single directive. 

Directive  89/392/EBC  on machinery1  has  covered  machinery  that 
can  be  used  in  potentially  explosive  atmospheres  or  which 
themselves can create such an atmosphere (Annex 1, Item 1.5.7 -
explosion hazards).  The intention of this directive as regards 
those same machines is to fine-tune the essential requirements 
applying  to  such hazards.  Prom  this  standpoint  it  will  thus 
constitute  a  separate directive deriving  from  Article 1(4) of 
the machinery directive. 

1  OJ  m  NO L 183, 29.6.1990. 

_ 4 -

-  The  aim  of  the  Directive  is  twofold:  (a)  the  removal  of 
barriers  to  trade  of  which  the  optional  directives  were  an 
initial  stage  and  (b) the  setting  of  a  hj^h uniform  level  of 
protection.  That aim would only be imperfectly  achieved if one 
restricted  oneself  to a sLmple removal  of existing  barriers  to 
trade  without  taking  account  of  the  means  of  avoiding  the 
raising  of  any  such  barriers.  Following  a  slow  pace  of 
technological  change  during  the  1970s  the  procedure  for  the 
provision  of  information  set  out  in  Directive 83/189/EEC  has 
enabled us to note an increase in the number of notifications of 
a  technical  nature  governing  either  aspects  of  or  complete 
sectors  within  the  ATEX  field.  We  can  quote  technical 
regulations  in  the  oil,  painting  and  printing  equipment 
industries,  measures  applying  to  electrostatic  discharges, 
certain  measuring 
of 
regulations of this type in not all of the Member States can in 
the long term only impede the free movement of ATEX equipment. 

instruments, 

etc.  The 

existence 

b.  Technical aspects 

The rapid changes in the situation as regards explosion hazards 
has  prompted  research  into  the  other  possible  sources  of 
ignition.  For the moment it has thus been possible to pinpoint 
13 of these, of which only half have been electrical in nature: 

Of  those mainly  of  the  electrical  type  we  can  quote  electric 
sparks,  arcs  and  flash  currents,  electrostatic  charges, 
electromagnetic  waves,  and  ionizing  radiation.  Those  of  a 
mainly  non-electric type under  consideration  are hot  surfaces, 
flames  and  hot  gases,  mechanically  generated  sparks,  optical 
radiation, ultrasound,  chemical  flame  initiation and  adiabatic 
cxampression. 

A taking account solely of electrical hazards would thus appear 
to  be  a  minimalist  approach  that  is  inadequate  in  aiming  at 

- 5 -

the high level of protection which Article 100(3) requires from 
the  Commission  in  preparing  its  proposals.  Moreover,  the 
interlinking  of  scientific disciplines  and  the  superposing  of 
the technologies applied make the distinction between  electric 
flrr>H non-electric equipment highly  troublesome and, ultimately, 
arbitrary. 

Apart  from  the  inclusion  of  non-electrical  equipment  the 
proposal  harmonizes  the  systems  intended  to  arrest  a  nascent 
explosion  or  else  to  limit  its  consequences  to  an  acceptable 
minimum.  It  is  accepted  that,  despite  the  upgrading  of 
equipment, it is impossible totally to exclude any possibility 
of explosion.  Downstream measures need, to be taken in order to 
achieve  total  safety.  Likewise  devices  located  outside 
potentially  explosive  atmospheres,  the  performance  of  which, 
however, has a direct impact on the safety of equipment within 
such atmospheres, are covered. 

Annex I  to  the directive defines five categories  of  equipment 
(three for surface equipment and two for mining equipment) which 
take practical form in the essential requirements listed in the 
Annex II  applying  to  them.  The  categories  correspond  in 
structural terms to a hierarchy of protection against explosions 
and are thus also linked to appropriate means of certification 
of conformity. 

The  directive  also  covers  equipment  designed  for  environments 
containing  mixtures  of  Inflammable  dusts.  The  very  usef of 
equipment  of  this  type  causes  national  discrepancies 
(determination  of  zones),  which  is  in  contrast  to  use  in 
potentially explosive gases, and on which a  consensus seems to 
be  forming  within  the  circles  involved.  Design  requirements 
will have a positive impact on the aspects linked with the use 
and installation of such equipment - an area to be governed in 
future by Article 118A directives. 

- 6 -

2. Economic and SQC&alJlJgrpaat. 

A. Economic impact 

ATEX equipment holds considerable économie appeal.  It is widely used in 
key  sectors  of  industry:  the  extraction  of  solid,  liquid  and  gaseous 
fuels  (coal,  oil  and  natural  gas),  the  chemical  and  metal-working 
industries,  the  treatment  of  inflammable  organic  products  (and  more 
especially  foods),  wood  and  plastic-treatment  facilities,  printing 
works,  eto.  Each  year  roughly  2 500  certificates  of  conformity  are 
issued following tests by the bodies officially appointed for electrical 
equipment.  This  raises purchase  prices  - a  trend which  will  continue 
into  the  future,  more  particularly  since  the  individual  requirements 
will  in  certain  cases  require  further  tests.  Moreover,  the 
non-repetition of tests of this type on the Community market will reduce 
manufacturers'  expenses  and,  indirectly,  those  of  users,  to  an 
acceptable level.  Although difficult  to quantify this is important  for 
safety and economic reasons in removing barriers to trade and finding a 
suitable  equilibrium.  This  is  why  the  directive  aims  to  create  or 
maintain a high level of safety within reasonable cost limits.  As they 
are a considerable asset in rationalizing and improving productivity the 
harmonized  standards  drawn  up  by  CEN  and  CENELEC  will  make  a  major 
contribution to the success of this proposal, which implements  the New 
Approach  principle.  In  parallel  to  this  the  directive  will  be  the 
driving force behind speeding up the standardization activities. 

B. fiodai aspects 

This  proposal  will  not  alter  established  structures.  However,- an 
overall  spread  of  safety  which  avoids  grey  areas  between  differing 
regulations  cannot  be underestimated  with regard  to  the users  of  such 
equipment.  It  should  be  noted  against  the  same  backdrop  that  this 
"design"  directive will be  supplemented  by  a  sister  directive dealing 
with  the use  of ATEX equipment,  the  latter having ;its legal  basis  in 
Article 118 A. 

- 7 -

C. Consultation of interested parties 

Government  and  private  experts helped  to  prepare  this directive,  the 
latter coming in particular from CRGALIME (the liaison organization for 
the European metal industries), CEFIC (European Council for the Chemical 
Industry  Federations),  the FIMTM  (Federation of  Engineering  and Metal 
Processing  Industries),  the  European  Standardization  bodies  GEN  and 
CENELEC.  The European Union of alcohol, brandy and spirit producers^and 
EOEOPLANT  have  pledged  their  support  for  .the Commission  in .writing. 

It has been put  to and discussed within the Consultative Committee on 
Safety, Hygiene and the Protection of Health at  the Workplace and the 
Safety  and  Health  Commission  for  the  Mining  and  other  Extractive 
Industries. 

Two  observers from the EFTA secretariat have also been present during 
the discussions. 

n. 

Tte  projxml for ft dlrfXTtlvft 

This is a  "New Approach" directive which ijmplements the guidelines set out 
in the Council Resolution of 7 May 1985.  It is based  on Article 10QA of 
the Treaty of Rome. 

1. Scope 

The Directive is broad in scope, covering both the electrical and.non 
electrical  fields,  protective  systems  and  such  devices  not  in 
potentially explosive atmospheres but having repercussions on equipment 
working in such atmospheres.  It covers an enoraious section of industry 
as explained in Chapter 1 and as governed by the Council Resolution of 
7 May 1985. 

2. Components. 

The problem of the treatment of components has been acknowledged by the 
Commission.  A definition is given in Article 1 and identifies  (a) the 
absence of stand-alone operation and  (b) any essential contribution to 
equipment safety. 

-  8 

The procedures  applying  to  changes  in conformity will be  governed  by 
those  for  the  category  for  which  the  œmplete  item  of  equipment  is 
intended.  Manufacturers will certify cxanpliance with the abovementioned 
procedures in a statement without, however, affixing the EC mark to the 
component 

3. Safety and health requirements 

A. Annex 1 - Criteria determining the assignment of groups of devices to 

conformity categories. 

Annex 1 to the directive is divided into two groups of device:  group 1 
governing mining equipment and group 2 surface equipment.  Each group is 
further  subdivided  into  conformity  categories  i.e. 1,  2  and  3  in  the 
case of surface equipment, (M)l and (M)2 for mining.  This list is based 
on a hierarchy of protective measures applying to that equipment.  Thus 
category  1  covers  equipment  providing  a  high level  of  protection and 
thus able to operate where there is a high probability  of potentially 
explosive atmospheres. 

In decreasing order categories 2 and 3 will be intended for environments 
in  which  potentially  explosive  atmospheres  are  less  probable.  The 
philosophy  for  group  1  is  similar.  The  idea  of  probability  is  of 
crucial importance in the area covered.  Users are required to pinpoint 
in their  facilities areas within which inflammable gases  or dusts are 
likely to be released or present with various degrees  of probability. 
The  parameters  taken  into  account  are  contained  in  either  national 
regulations  or  international  standards.  Harmonization  can  only  be 
^contemplated via an Article 118A directive and is not dealt with in this 
proposal.  However, the requirement categories set out therein aim, in 
structural  and  design  terms,  at  an  identical  intrinsic  level-of 
equipment 
designed 
combination 
specifically  in  line  with  certain  conformity  categories  and , its 
installation/use in line with manufacturers' instructions 

protection.  The 

equipment 

of 

9  -

must provide a maximum level of safety. 

In an industrial environment the measures intended to protect against 
explosions caused by inflammable dusts have been placed in an 
appropriate category depending upon the potential hazard. 

Thifi does not mean identical design for equipment intended for use in 
dusty atmospheres or gaseous environments.  The basic requirements set 
out in Annex II are entirely specif io and relate to the abovementioned 
intended use.  In this case assignment to one and the same category 
derives first and foremost from identical conformity certification 
procedures.  It is thus suggested that the equipment should be placed in 
Category 1 or 3. 

B. Annex II - TVi^-lp safety• rfypilT™imt« 

Annex II sets out the basio general and specific requirements to be met 
by items of equipment in the light of the abovementioned classification. 
The two annexes thus constitute an inseparable whole.  The risks 
involved are in principle in direct relation with the explosion of the 
potentially explosive atmosphere.  The essential requirements of 
machinery directive 89/392/EEC shall also apply to other risks due, for 
example, to the use of a machine in potentially explosive atmospheres. 

4. Conformity assessment procedures 

The procedures described in detail in the following article take the* 
form of a hierarchy relating to the levels of risk for which equipment 
is Intended.  As a general rule the choice is left to manufacturers as 
to whether or not to apply quality assurance systems. 

- 10 -

The procedures can be summarized as follows: 

A.  Equipment. 1nf>^y11ng W^^-PA  rvneaaaTy. rtpwinfla not in potentially 

explosive atmospheres fortr Hnftflfl to ATl1rimf?Pt ^ P ^^  t^T^-tO, and 
Integrated protection systems 

1. Groups I and II, conformity category (M)l and 1 

either EEC type examination (module B) + 

- production quality assurance (mod. D) 

or 

- on-produot check (mod. F) 

or complete quality assurance (mod. H) 

2. Groups I and II, conformity category (M)2 and 2 

EC type approval (mod. B) + 

- conformity with type (mod. C) 

or 

- product quality assurance (mod. E) 

3. Group II, conformity category 3 

only applying to surface industries: 

- internal manufacturing inspection (mod. A) 

B. 

Autonomously functioning proteotive systems 

EC type examination (mod. B) + 

- conformity to type (mod. C) 

or 

- product quality assurance (mod. E) 

In all cases manufacturers have the option of resorting to the EC unit 
verification procedure (mod. G ). 

- 11 -

5. Means of conformity 

The proposal takes account of the most recent situation as regards the 
use of the EC mark.  -However, in order to avoid any confusion and to 
draw user attention to the particular characteristics of the equipment, 
provision is made for the addition of further markings.  This will 
include, in particular, a specific explosion prevention sign, the 
equipment-group symbol (I - mining, II - surface industries), the 
conformity category M(l), M(2), 1, 2 or 3, the .nature of the potentially 
explosive mixture (G: gas, D: dusts), and all restrictions on the use or 
conditions applying to safe use. 

6.  P^p^l  nf redoing fllxflflUvftf* 

This proposal for a directive completely replaces the harmonization 
introduced by Directives 76/117/EBC, 79/196/EEC, 90/487/EEC and 
82/130/EBC and their successive amendments, which will therefore be 
repealed.  Nevertheless, the present system has in the past guaranteed a 
high level of protection which should therefore not be impaired.  The 
achievements applying to electrical equipment will therefore in essence 
be retained subject, naturally, to an examination of the scope for 
improvement.  The high level already existing will, moreover, be 
extended to cover equipment not currently dealt with by Community law. 

7. PmdHne for entry into force 

The intention is to implement the directive in two stages: 

- optional ijmplementation: 1 July 1993 
- total implementation: 

1.1.2003 

The optional period is justified for the setting up of any specific test 
and certification structures and to avoid massive demand and thus excessive 
time lags. 

Indeed, although few changes to test facilities seem necessary in the 
electrical field the same does not apply to the non-electrical field where 
a great deal of work is required, in particular on the preparation of 
harmonized standards. 

-  12  -

COUNCIL  D I R E C T I VE 

on  the  a p p r o x i m a t i on  of  the  laws 

of  the  Member  States  c o n c e r n i ng  equipment  and 

p r o t e c t i ve  s y s t e ms  Intended  for  use  In 

p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r es 

THE  COUNCIL  OF  THE  EUROPEAN  C O M M U N I T I ES 

Having 

regard 

to  the  Treaty  e s t a b l i s h i ng 

the 

E u r o p e an 

Economic  C o m m u n i t y,  and  In  p a r t i c u l ar  A r t i c le  100A  t h e r e o f; 

Having  regard  to  the  proposal  from  the  Commission-,1 

In  c o o p e r a t i on  with  the  European  P a r l i a m e n t ;2 

Having  regard  to  the  o p i n i on  of  the  Economic  and  Social 

Comm11 tee ; 3 

W h e r e as  It  is  the  duty  of  Member  S t a t es  to  p r o t e c t,  on  their 

t e r r i t o r y,  the  safety  and  health  of  p e r s o ns  and,  where 

a p p r o p r i a t e, 

d o m e s t ic 

animals 

and 

property 

and, 

In 

p a r t i c u l a r,  that  of  w o r k e r s,  e s p e c i a l ly  against  the  h a z a r ds 

resulting  from  the  use  of  equipment  and  s y s t e ms  p r o v i d i ng 

p r o t e c t i on  against  p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r e s; 

1 
2 
3 

OJ  EC  ( 
0J  EC  ( 
0J  EC  ( 

) . 
) . 
) . 

-  13  -

W h e r e as 

m a n d a t o ry 

p r o v i s i o ns 

w i t h in 

t he 

M e m b er  S t a t es 

d e t e r m i ne  t he  level  of  s a f e ty  to  be  a c h i e v ed  by  p r o t e c t i ve 

e q u i p m e nt 

a nd 

s y s t e ms 

I n t e n d ed 

for 

u se 

in 

p o t e n t i a l ly 

e x p l o s i ve 

a t m o s p h e r e s; 

w h e r e as 

t h e se 

a re 

g e n e r a l ly 

e l e c t r i c al 

a nd 

n o n - e l e c t r i c al 

s p e c i f i c a t i o ns 

h a v i ng 

an 

e f f e ct  on  t he  d e s i gn  and  s t r u c t u re  of  e q u i p m e nt  that  c an  be 

u s ed  in  p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r e s; 

W h e r e as  t he  r e q u i r e m e n ts  to  be  met  by  s u ch  e q u i p m e nt  d i f f er 

f r om  o ne  M e m b er  S t a te  to  a n o t h er  In  r e s p e ct  of  t h e ir  e x t e nt 

and 

d i f f e r i ng 

i n s p e c t i on 

p r o c e d u r e s; 

w h e r e as 

t h e se 

d i f f e r e n c es  a re  t h e r e f o re  l i k e ly  to  r a i se  b a r r i e rs  to  t r a de 

w i t h in  t he  C o m m u n i t y; 

W h e r e as 

t he 

r e g u l a t i o ns 

I n t e n d ed 

to 

r e m o ve 

t e c h n i c al 

b a r r i e rs  to  t r a de  a re  r e q u i r ed  to  f o l l ow  the  n ew  a p p r o a ch 

p r o v i d ed 

for 

In  the  C o u n c il 

R e s o l u t i on 

of 

7  M ay  1 9 8 5 ,4 

w h i ch  r e q u i r es  a  d e f i n i t i on  of  the  e s s e n t i al 

r e q u i r e m e n ts 

r e g a r d i ng  s a f e ty  and  o t h er  r e q u I r e m e n ts  • of  s o c i e ty  w i t h o ut 

r e d u c i ng  e x i s t i n g,  j u s t i f i ed  l e v e ls  of  p r o t e c t i on  w i t h in  the 

M e m b er  S t a t e s; 

w h e r e as  that  r e s o l u t i on  p r o v i d es  that  a  v e ry 

l a r ge  n u m b er  of  p r o d u c ts  be  c o v e r ed  by  a  s i n g le  d i r e c t i ve  -In'** 

o r d er  to  a v o id  f r e q u e nt  a m e n d m e n ts  and  the  p r o l i f e r a t i on  of 

d i r e c t I v e s; 

W h e r e as  the  e x i s t i ng  d i r e c t i v es  on  the  a p p r o x i m a t i on  of  the 

l a ws  of  t he  M e m b er  S t a t es  r e l a t i ng  to  e l e c t r i c al 

e q u i p m e nt 

for 

u se 

In  p o t e n t i a l ly 

e x p l o s i ve 

a t m o s p h e r es 

h a ve 

m a de  > 

p o s i t i ve 

s t e ps 

t o w a r ds 

p r o t e c t i on 

a g a i n st 

0J  EC  No  C  1 3 6,  4 . 6 . 1 9 8 5,  p.  1. 

14  -

e x p l o s i o ns  via  m e a s u r es  linked  w i th  the  s t r u c t u re  of  the 

e q u i p m e nt  at  Issue  and  w h i ch  h a ve  h e l p ed  to  r e m o ve  b a r r i e rs 

to  t r a de  In  t h is  a r e a. 

W h e r e a s,  In  p a r a l l e l,  a  r e v i s i on  and 

e x p a n s i on  of  the  e x i s t i ng  d i r e c t i v es 

Is  n e c e s s a ry 

s i n c e, 

m o re  p a r t i c u l a r ly 

In  an  o v e r a ll  c o n t e x t,  a c t i on  m u st 

be 

taken  to  g u a rd  a g a i n st  the  p o t e n t i al  h a z a r ds  a r i s i ng  from 

such  e q u i p m e n t. 

T h is  I m p l i es  in  p a r t i c u l ar  that  m e a s u r es 

I n t e n d ed 

to  g u a r a n t ee  e f f e c t i ve  p r o t e c t i on  of  u s e rs 

and 

third  p a r t i es  must  a l r e a dy  be  c o n t e m p l a t ed  at  the  d e s i gn  and 

m a n u f a c t u r i ng  s t a g e s; 

W h e r e as 

the 

form 

t a k en 

by 

the 

h a z a r d, 

the 

p r o t e c t i ve 

m e a s u r es  and  the  test  m e t h o ds  are  o f t en  very  s i m i l a r,  if  not 

I d e n t i c a l,  for  b o th  m i n i ng  and  s u r f a ce  e q u i p m e n t;  w h e r e as  it 

Is  t h e r e f o re 

an  a b s o l u te 

n e c e s s i ty 

to  c o v er 

p r o t e c t i ve 

e q u i p m e nt  and  s y s t e ms  f a l l i ng  w i t h in  both  g r o u ps  by  a  s i n g le 

d i r e c t i v e; 

W h e r e as  the  two  g r o u ps  of  e q u i p m e nt  r e f e r r ed  to  a b o ve  are 

used  in  a  large  n u m b er  of  c o m m e r c i al  and  i n d u s t r i al  s e c t o rs 

and  p o s s e ss  c o n s i d e r a b le  e c o n o m ic  s i g n i f i c a n c e; 

W h e r e as 

c o m p l i a n ce 

w i th 

the  - b a s ic 

s a f e ty 

and 

h e a l th 

r e q u i r e m e n ts  is  e s s e n t i al  in  o r d er  to  e n s u re  the  s a f e ty  of 

p r o t e c t i ve  e q u i p m e nt  and  s y s t e m s;  w h e r e as  t h o se  r e q u i r e m e n ts 

have 

b e en 

s u b d i v i d ed 

into 

g e n e r al 

and 

a d d i t i o n al 

r e q u i r e m e n ts  w h i ch  must  be  met  by  p r o t e c t i ve  e q u i p m e nt  and 

s y s t e m s;  w h e r e as  in  p a r t i c u l ar  the  a d d i t i o n al 

r e q u i r e m e n ts 

are 

i n t e n d ed 

to  take  a c c o u nt 

of  e x i s t i ng 

or 

p o t e n t i al 

h a z a r d s; 

w h e r e as 

p r o t e c t i ve 

e q u i p m e nt 

and 

s y s t e ms 

will 

t h e r e f o re  e m b o dy  at  least  o ne  of  those  r e q u i r e m e n ts  w h e re 

-  15  -

this  is  n e c e s s a ry  for  their  p r o p er  f u n c t i o n i ng  or  Is  to 

apply  to  their  intended  u s e;  w h e r e as  the  n o t i on  of  intended 

use  is  of  p r i me  I m p o r t a n ce  for  the  e x p l o s i o n - p r o o f i ng  of 

p r o t e c t i ve  e q u i p m e nt  and  s y s t e m s;  w h e r e as  It  is  e s s e n t i al 

that 

m a n u f a c t u r e rs 

s u p p ly 

full 

I n f o r m a t i o n; 

w h e r e as 

s p e c i f i c,  c l e ar  m a r k i ng  of  said  e q u i p m e n t,  s t a t i ng  Its  use 

In  a  p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r e,  Is  a l so  n e c e s s a r y; 

W h e r e as  the  p r e s e nt  I n t e n t i on  is  to  p r e p a re  a  d i r e c t i ve  on 

o p e r a t i o ns 

in  p o t e n t i a l ly 

e x p l o s i ve 

a t m o s p h e r es 

that 

is 

b a s ed  on  A r t i c le  118A;  w h e r e as  that  a d d i t i o n al 

d i r e c t i ve 

w i l l,  In  p a r t i c u l a r,  aim  at  e x p l o s i on  h a z a r ds  that  d e r i ve 

from  a  g i v en  use  a n d / or  t y p es  and  m e t h o ds  of  I n s t a l l a t i o n; 

W h e r e as 

judgment 

will 

have 

to 

be 

e x e r c i s ed 

in 

the 

I m p l e m e n t a t i on 

of 

t h o se 

r e q u i r e m e n ts 

in  o r d er 

to 

take 

account 

of 

the 

t e c h n o l o gy 

a v a i l a b le 

at 

the 

time 

of 

m a n u f a c t u re ; 

W h e r e as  this  d i r e c t i ve  t h e r e f o re  o n ly  s e ts  out 

e s s e n t i al 

r e q u i r e m e n t s;  w h e r e as  in  o r d er  to  e a se  the  task  of  p r o v i ng 

c o m p l i a n ce 

w i th 

the 

e s s e n t i al 

r e q u i r e m e n ts 

s t a n d a r ds 

h a r m o n i z ed  at  E u r o p e an  level  are  n e c e s s a r y,  m o re  e s p e c i a l ly 

w i th  r e g a rd 

to  the  n o n - e l e c t r i c al 

a s p e c ts  of 

p r o t e c t i on 

a g a i n st 

e x p l o s i o ns  -  s t a n d a r ds 

r e l a t i ng 

to 

the 

d e s i g n, 

m a n u f a c t u re  and  t e s t i ng  of  e q u i p m e n t,  c o m p l i a n ce  w i th  w h i ch 

e n a b l es  a  p r o d u ct  to  be  p r e s u m ed  to  meet  said  e s s e n t i al 

r e q u i r e m e n t s;  w h e r e as  s t a n d a r ds  h a r m o n i z ed  at  E u r o p e an  level 

-  16  -

are  drawn  up  by  private  bodies  and  must 

retain 

their 

n o n - m a n d a t o ry 

s t a t u s; 

w h e r e a s, 

for 

this 

p u r p o s e, 

the 

European 

C o m m i t t ee 

for 

S t a n d a r d i z a t i on 

(CEN) 

and 

the 

European  C o m m i t t ee  for  E I e c t r o t e c h n i ca I  S t a n d a r d i z a t i on  are 

recognized  as  being  the  bodies  that  are  competent  to  adopt 

harmonized  s t a n d a r ds  that  follow  the  general  g u l d e l I n es  for-

c o o p e r a t i on  between  the  C o m m i s s i on  and  those  two  b o d i es 

signed  on  13  November  1984;  w h e r e a s,  for  the  p u r p o s es  of 

this 

d i r e c t i v e, 

a  harmonized 

standard 

Is  a 

technical 

s p e c i f i c a t i on  (European  Standard  or  h a r m o n i z a t i on  d o c u m e n t) 

adopted  by  one  or  other  of  those  b o d i e s,  or  by  b o t h,  at  the 

prompting 

of 

the 

Commission 

in  p u r s u a n ce 

of 

Council 

D i r e c t i ve 

8 3 / 1 8 9 / E EC 

of 

28  March  1983 

p r o v i d i ng 

for 

a 

p r o c e d u re 

g o v e r n i ng 

the 

p r o v i s i on 

of 

Information 

on 

technical  s t a n d a r ds  and  r e g u l a t i o n s ,5  as  last  amended  by 

D i r e c t i ve 

8 8 / 1 8 2 / E E C6  and 

In  p u r s u a n ce  of 

the 

general 

g u i d e l i n es  referred  to  a b o v e; 

W h e r e a s,  in  view  of  the  nature  of  the  risks  Involved  in  the 

use  of  equipment  in  p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r es  it  Is 

necessary  to  establish  p r o c e d u r es  applying  to  the  assessment 

of  c o m p l i a n ce  with  the  basic  r e q u i r e m e n ts  of  the  d i r e c t i v e s; 

w h e r e as  these  p r o c e d u r es  must  be  devised  In  the  light  of  the 

level  of  danger  which  may  be  Inherent  In  equipment  and/or 

against 

which 

systems 

must 

protect 

the 

Immediate 

e n v i r o n m e n t;  w h e r e as  therefore  each  c a t e g o ry  of  equipment 

conformity  must  be  s u p p l e m e n t ed  by  an  a d e q u a te  p r o c e d u re  or 

a  choice  between  several  equivalent  p r o c e d u r e s;  w h e r e as  the 

p r o c e d u r es  adopted  are  fully  as  required  by  the  Council 

decision  of  13  December  1 9 9 07  c o n c e r n i ng  the  m o d u l es  for 

the  v a r i o us  p h a s es  of  the  conform Ity  a s s e s s m e nt  p r o c e d u r es 

which  are  Intended  to  be  used  in  the  technical  h a r m o n i z a t i on 

d I rect I ves ; 

5 

6 

7 

0J  No  L  109,  2 6 . 4 . 1 9 8 3,  p.  8. 

0J  No  L  8 1,  2 6 . 3 . 1 9 8 8,  p.  7 5. 

0J  No  L  7,  3 8 0,  3 1 . 1 2 . 1 9 9 0,  p.  13. 

-  17  -

W h e r e as  the  Council  has  provided  for  the  a f f i x i ng  of  the  EC 

mark  either 

by  the  m a n u f a c t u r er 

or  by  his 

a u t h o r i z ed 

r e p r e s e n t a t i ve  w i t h in  the  Commun Ity  o r,  fallIng  that,  by  the 

person  r e s p o n s i b le  for  placing  that  product  on  the  c o m m u n i ty 

m a r k e t;  w h e r e as  that  mark  m e a ns  that  ttie  product'  c o m p l i es 

with  all  the  basic  r e q u i r e m e n ts  and  a s s e s s m e nt  p r o c e d u r es 

provided  for  by  the  Community  law  applying  to  that  p r o d u c t; 

W h e r e as 

it 

is  a p p r o p r i a te 

that 

the  Member 

S t a t e s,  as 

provided 

for  by  A r t i c le  100a  of  the  T r e a t y,  may 

take 

temporary  m e a s u r es  to  limit  or  prohibit  the  p l a c i ng  on  the 

market  and  the  use  of  equipment  and  p r o t e c t i ve  s y s t e ms  in 

cases  w h e re  they  present  a  p a r t i c u l ar  risk  to  the  safety  of 

persons 

and, 

w h e re 

a p p r o p r i a t e, 

d o m e s t ic 

a n i m a ls 

or 

p r o p e r t y,  p r o v i d ed 

that  the  m e a s u r es  are  subject 

to  a 

Community  control  p r o c e d u r e; 

W h e r e as  the  r e c i p i e n ts  of  any  d e c i s i on  taken  as  part  of  this 

d i r e c t i ve  must  be  aware  of  the  reasons  behind  that  d e c i s i on 

and  the  m e a ns  of  appeal  open  to  them; 

W h e r e a s, 

on 

18 

December  1 9 7 5, 

the 

Council 

a d o p t ed 

a 

framework  d i r e c t i ve  on  electrical 

equipment 

for  use  in 

p o t e n t i a l ly 

e x p l o s i ve 

a t m o s p h e r es 

( 7 6 / 1 1 7 / E E C )8  as 

last 

amended  by  D i r e c t i ve  9 0 / 4 7 / E E C9  and,  on  15  F e b r u a ry  1982  a 

8 

9 

0J  No  L  2 4,  3 1 . 1 . 1 9 7 6,  p.  4 5. 

0J  No  L  2 7 0,  2 . 1 0 . 1 9 9 0,  p.  2 3. 

-  18  -

d i r e c t i ve 

c o n c e r n i ng 

electrical 

equipment 

for 

use 

in 

p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r es  in  m i n es  s u s c e p t i b le  to 

fire  damp 

( 8 2 / 1 3 0 / E E C )1°  as 

last  amended 

by 

D i r e c t i ve 

9 1 / 2 6 9 / E E C ;11  w h e r e a s,  from  the  outset  of  the  h a r m o n i z a t i on 

a c t i v i t i e s,  the  c o n v e r s i on  of  the  optional 

and 

partial 

h a r m o n i z a t i on  on  which  these  d i r e c t i v es  are  based  Into  total 

h a r m o n i z a t i on  had  been  c o n t e m p l a t e d;  w h e r e as  this  d i r e c t i ve 

fully  c o v e rs  the  scope  of  the  above  m e n t i o n ed  d i r e c t i v es  and 

w h e r e as  t h e r e f o re  these  d i r e c t i v es  must  be  r e p e a l e d; 

W h e r e as  the  m e a s u r es  Intended  g r a d u a l ly  to  introduce  the 

internal  market  must  be  adopted  before  31  December  1 9 9 2; 

w h e r e as  the  internal  market  incorporates  an  area  without 

internal  f r o n t i e rs  within  which  the  free  movement  of  g o o d s, 

p e r s o n s,  s e r v i c es  and  capital  Is  a s s u r e d; 

W h e r e as 

it  is  necessary 

to  provide  for  a  transitional 

arrangement  enabling  equipment  m a n u f a c t u r ed 

In  c o m p l i a n ce 

with  the  national 

r e g u l a t i o ns 

in  force  at  the  date  of 

adoption  of  this  d i r e c t i ve  to  be  m a r k e t ed  and  placed  In 

service  is  n e c e s s a r y, 

HAS  A D O P T ED  THIS  D I R E C T I V E: 

10 

11 

OJ  No  L  5 9,  2 . 3 . 1 9 8 2,  p.  1 0. 

OJ  No  L  134,  2 9 . 5 . 1 9 9 1. 

19  -

C h a p t er  I 

S c o p e,  p l a c i ng  on  the  m a r k et  and  f r e e d om  of  m o v e m e nt 

Art Icle  1 

T h is  D i r e c t i ve 

a p p l i es 

to  e q u i p m e nt 

and 

p r o t e c t i ve 

s y s t e ms 

I n t e n d ed 

for 

use 

in  p o t e n t i a l ly 

e x p l o s i ve 

a t m o s p h e r e s. 

S a f e ty 

dev I ces , • c o n t r oI I Ing 

d e v i c e s-  and 

r e g u l a t i ng 

d e v i c es 

for 

u se 

o u t s i de 

p o t e n t i a l ly 

e x p l o s i ve 

a t m o s p h e r es  but  r e q u i r ed  or  c o n t r i b u t i ng  to  the  s a fe 

f u n c t i o n i ng 

of 

e q u i p m e nt 

and 

p r o t e c t i ve 

s y s t e ms 

located 

Inside  p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r es  are 

c o v e r ed  by  the  s c o pe  of  t h is  D i r e c t i v e. 

For 

the 

p u r p o s es 

of 

this 

D i r e c t i ve 

the 

f o l l o w i ng 

d e f i n i t i o ns  shall  a p p l y: 

E q u i p m e nt  and  p r o t e c t i ve  s y s t e ms  i n t e n d ed  for  u se  in 

p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r es 

a)  " E q u i p m e n t"  m e a ns  m a c h i n e s,  a p p a r a t us 

and  all  o t h er 

fixed  or  m o b i le  d e v i c e s,  I n c l u d i ng  the  c a b le  and 

c o n d u it 

e n t r i e s, 

c o n t r ol 

c o m p o n e n ts 

and 

I n s t r u m e n t a t i on 

t h e r e o f, 

w h i ch 

s e p a r a t e ly 

or 

J o i n t l y,  p e r m a n e n t ly  or  o c c a s i o n a l ly  are  u s ed  for 

the 

g e n e r a t i o n, 

t r a n s f e r, 

d i s t r i b u t i o n, 

s t o r a g e, 

m e a s u r e m e n t,  c o n t r ol  and  c o n v e r s i on  of  e n e r gy  and 

for 

the 

p r o c e s s i ng 

of 

m a t e r i al 

and 

c a p a b le 

of 

c a u s i ng  an  e x p l o s i o n. 

-  20  -

b)  T he 

term 

" p r o t e c t i ve 

s y s t e m s"  a p p l i es 

to 

d e s i gn 

u n i ts 

w h i ch 

are 

Intended 

to 

halt 

Incipient 

e x p l o s i o ns  i m m e d i a t e ly  and/or  to  limit  the  e f f e c t e d* 

r a n ge  of  e x p l o s i on  f l a m es  and  e x p l o s i on  p r e s s u r es  to 

a  s u f f i c i e nt  level  of  s a f e t y.  P r o t e c t i ve  s y s t e ms  can 

be  i n t e g r a t ed  into  e q u i p m e nt  or  s e p a r a t e ly  m a r k e t ed  • 

for  t r a de  use  as  a u t o n o m o us  s y s t e m s. 

c)  " C o m p o n e n t s"  m e a ns  any  item  b e i ng  e s s e n t i al  to  the 

s a fe  f u n c t i o n i ng  of  e q u i p m e nt  and  p r o t e c t i ve  s y s t e ms 

but  not  h a v i ng  an  a u t o n o m o us  f u n c t i o n. 

E x p l o s i ve  a t m o s p h e r es 

M i x t u re  of  a Ir  and  f l a m m a b le  g a s e s,  v a p o u r s,  h a z es  or  d u s ts 

in  such 

p r o p o r t i o ns 

under 

a t m o s p h e r ic 

c o n d i t i o n s, 

t h a t, 

after 

i g n i t i on 

has 

o c c u r r e d, 

a 

r e a c t i on 

i n v o l v i ng 

a 

t e m p e r a t u re 

and 

p r e s s u re 

increase 

can 

p r o p a g a te 

i n d e p e n d e n t ly  and  can  c a u se  a  h a z a r d. 

P o t e n t i a l ly  e x p l o s i ve  a t m o s p h e re 

An  a t m o s p h e re  w h i ch  c o u ld  b e c o me  e x p l o s i ve  due  to  local  and  <• 

o p e r a t i o n al  c o n d i t i o n s. 

E q u i p m e n t - g r o u ps  and  C o n f o r m i ty  c a t e g o r i es 

E q u i p m e n t - g r o up 

I 

a p p l i es 

to 

e q u i p m e nt 

for 

u se 

in 

u n d e r g r o u nd  p a r ts  of  m i n es  as  well  as  those  p a r ts  of  s u r f a ce 

i n s t a l l a t i o ns  of  such  m i n es  likely  to  b e c o me  e n d a n g e r ed  by 

f i r e d a mp  a n d / or 

c o m b u s t i b le  d u s t. 

E q u i p m e n t - g r o up  II  a p p l i es  to  e q u i p m e nt  for  u se  in  o t h er 

p l a c es  likely  to  b e c o me  e n d a n g e r ed  by  e x p l o s i ve  a t m o s p h e r e s. 

21  -

C o n f o r m i ty  c a t e g o r i es 

are  d e f i n ed  in  A n n ex  I w i th  r e g a rd  to 

the  level  of  p r o t e c t i on  r e q u i r ed 

for  e q u i p m e n t. 

E q u i p m e nt 

and  p r o t e c t i ve 

s y s t e ms  may  be  d e s i g n ed 

for  --as* 

p a r t i c u l ar 

e x p l o s i ve 

a t m o s p h e r e. 

In  t h is 

c a se 

they 

are 

m a r k ed  a c c o r d i n g l y. 

I n t e n d ed  u se 

T he  u se  of  e q u i p m e nt  and  p r o t e c t i ve  s y s t e ms  a c c o r d i ng  to  the 

e q u i p m e n t - g r o up  and  the  c o n f o r m i ty  c a t e g o ry  as  well  as  all 

the  i n f o r m a t i on  n e c e s s a ry  to  the  s a f e ty  of  the  e q u i p m e nt 

s u p p l i ed  by  the  m a n u f a c t u r e r. 

4. 

The  f o l l o w i ng 

are  e x c l u d ed 

from 

the  s c o pe  of 

t h is 

D i r e c t i v e: 

med i caI 

dev i ces 

I n t e n d ed 

for 

use 

In  med i caI 

e n v I r o n m e nt , 

e q u i p m e nt 

and  p r o t e c t i ve 

s y s t e ms 

in  so  far  as 

the 

e x p l o s i on 

h a z a rd 

is  e x c l u s i v e ly 

r e s u l t i ng 

from 

the 

p r e s e n ce  of  e x p l o s i ve  or  c h e m i c al  i n s t a b le  s u b s t a n c e s, 

s e a g o i ng  v e s s e ls  and  m o b i le  o f f s h o re  u n i ts 

t o g e t h er 

w i th  e q u i p m e nt 

and  p r o t e c t i ve  s y s t e ms  on  b o a rd 

such 

v e s s e Is  or  un Its . 

m e a ns  of  t r a n s p o r t,  I.e.  v e h i c l es  and  their 

t r a i l e rs 

I n t e n d ed  s o l e ly  for  t r a n s p o r t i ng  p a s s e n g e rs  by  air  or 

on  r o a d,  rail  or  w a t er  n e t w o r k s,  as  well  as  m e a ns  of 

t r a n s p o rt 

Insofar 

as 

such 

m e a ns 

are 

d e s i g n ed 

for 

t r a n s p o r t i ng 

g o o ds  by  a i r,  on  p u b l ic  road  or 

rail 

n e t w o r ks  or  on  w a t e r.  V e h i c l es  u s ed 

In  the  m i n e r al 

e x t r a c t i on  i n d u s t ry  shall  not  be  e x c l u d e d. 

-  22  -

Art Icle  2 

M e m b er 

S t a t es  shall 

take  all  n e c e s s a ry 

m e a s u r es 

to 

e n s u re 

that 

the 

e q u i p m e nt 

and 

p r o t e c t i ve 

s y s t e ms 

c o v e r ed  by  this  D i r e c t i ve  m ay  be  p l a c ed  on  the  m a r k et 

and  put  Into  s e r v i ce  o n ly  If  they  do  not  J e o p a r d i ze  the 

h e a l th  and  s a f e ty  of  p e r s o ns  a n d,  w h e re  a p p r o p r i a t e, 

d o m e s t ic  a n i m a ls  or  p r o p e r t y,  w h en  p r o p e r ly 

I n s t a l l ed 

and  m a i n t a i n ed  and  u s ed  for  its  i n t e n d ed  p u r p o s e. 

T h is  D i r e c t i ve  shall  not  a f f e ct  the  a u t h o r i ty  of  the 

M e m b er  S t a t es  to  lay  d o w n,  w i th  due  r e g a rd  for  the 

p r o v i s i o ns 

of 

the 

T r e a t y, 

r e q u i r e m e n ts 

w h i ch 

they 

c o n s i d er  n e c e s s a ry  for  the  p r o t e c t i on  of  p e r s o ns  and  in 

p a r t i c u l ar  of  e m p l o y e es  u s i ng  the  r é v é l a nt 

e q u i p m e nt 

and  p r o t e c t i ve  s y s t e m s,  p r o v i d ed  t h is  d o es  not  r e s u lt 

in  c h a n g es  to  e q u i p m e nt  and  p r o t e c t i ve  s y s t e ms  w i th 

r e s p e ct  to  the  p r o v i s i o ns  of  this  D i r e c t i v e. 

At  t r a de  f a i r s,  e x h i b i t i o n s,  d e m o n s t r a t i o n s,  e tc  M e m b er 

S t a t es  shall  not  p r e v e nt  the  s h o w i ng  of  e q u i p m e nt  and 

p r o t e c t i ve 

s y s t e ms 

w h i ch 

d o es 

not 

c o n f o rm 

to 

the 

p r o v i s i o ns  of  t h is  D i r e c t i v e,  p r o v i d ed  that  a  visible-•<*-

sign 

c l e a r ly 

i n d i c a t es 

that 

such 

e q u i p m e nt 

and 

p r o t e c t i ve  s y s t e ms  do  not  c o n f o rm  and  that  It  is  not 

for  s a le  until  It  has  b e en  b r o u g ht  into  c o n f o r m i ty  by 

the 

m a n u f a c t u r er 

or 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve 

e s t a b l i s h ed 

in  the  C o m m u n i t y.  D u r i ng 

d e m o n s t r a t i o n s, 

a d e q u a te  s a f e ty  m e a s u r es  shall  be  t a k en  to  e n s u re  the 

p r o t e c t i on  of  p e r s o n s. 

Art le le  3 

E q u i p m e nt  and  p r o t e c t i ve  s y s t e ms  r e f e r r ed  to  In  A r t i c le 

1 

must 

meet 

the 

e s s e n t i al 

h e a l th 

and 

s a f e ty 

r e q u i r e m e n ts  set  out  In  A n n ex  II  w h i ch  shall  a p p ly  to 

t h e m,  a c c o u nt  b e i ng  t a k en  of  their  I n t e n d ed  u s e. 

-  23  -

A r t i c le  4 

M e m b er  S t a t es  shall  not  p r o h i b i t,  r e s t r i ct  or 

Impede 

the  p l a c i ng  on  the  m a r k et  and  the  p u t t i ng  Into  s e r v i ce 

In  their  t e r r i t o ry  of  e q u i p m e nt  and  p r o t e c t i ve  s y s t e ms 

w h i ch  c o m p ly  w i th  the  p r o v i s i o ns  of  t h is  D i r e c t i v e. 

M e m b er  S t a t es  shall  not  p r o h i b i t,  r e s t r i ct  or 

Impede 

the 

p l a c i ng 

on 

the 

m a r k et 

of 

c o m p o n e n ts 

w h i c h, 

a c c o m p a n i ed  by  a  d e c l a r a t i on  as  r e f e r r ed  to  in  A r t i c le 

8  ( 4 ),  are  Intended  to  be  i n c o r p o r a t ed  into  e q u i p m e nt 

or 

p r o t e c t i ve 

s y s t e ms 

w i t h in 

the 

m e a n i ng 

of 

this 

D I rect i v e. 

Art Icle  5 

M e m b er 

S t a t es 

shall 

p r e s u me 

c o m p l i a n ce 

w i th 

the 

e s s e n t i al  h e a l th  and  s a f e ty  r e q u i r e m e n ts  r e f e r r ed  to  in 

A r t i c le  3  for  e q u i p m e nt  and 

p r o t e c t i ve  s y s t e ms  for 

u se  In  p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r es  If  t h o se  items 

compI y  w i th 

(a) 

the  r e l e v a nt 

n a t i o n al 

s t a n d a r ds  a p p l i c a b le 

to: 

them  i m p l e m e n t i ng  the  h a r m o n i z ed  s t a n d a r ds  w h o se 

r e f e r e n ce 

n u m b e rs 

h a ve  b e en 

p u b l i s h ed 

In 

the 

O f f i c i al 

J o u r n al 

of 

the 

E u r o p e an 

C o m m u n i t y. 

M e m b er 

S t a t es  shall 

p u b l i sh 

the  r e f e r e n c es  of 

n a t i o n al 

s t a n d a r ds 

t r a n s p o s i ng 

h a r m o n i z ed 

s t a n d a r ds . 

( b) 

or  the  r e l e v a nt  n a t i o n al  s t a n d a r ds  r e f e r r ed  to  In 

p a r a g r a ph 

2 

w h e re 

t h e re 

a re 

no 

h a r m o n i z ed 

s t a n d a r ds  d e a l i ng  w i th  the  a r e as  c o v e r ed  by  t h o se 

s t a n d a r d s. 

-  24  -

M e m b er  S t a t es  shall  c o m m u n i c a te  to  the  C o m m i s s i on  the 

t e x ts 

of 

their 

n a t i o n al 

s t a n d a r ds 

r e f e r r ed 

to 

In 

p a r a g r a ph  1 ( b)  w h i c h,  in  their  v i e w,  meet  the  e s s e n t i al 

r e q u i r e m e n ts  u n d er  A r t i c le  3. 

In  a c c o r d a n ce  w i th  the  p r o c e d u re  set  out 

In  A r t i c le 

6 ( 2 ), 

the  C o m m i s s i on 

shall 

I n d i c a te 

to  the 

M e m b er 

S t a t es  w h i ch  of  the  said  s t a n d a r ds  can  be  p r e s u m ed  to 

c o n f o rm  w i th  the  e s s e n t i al  s a f e ty  r e q u i r e m e n ts  w i t h in 

the  m e a n i ng  of  A r t i c le  3. 

Art Icle  6 

W h e re  a  M e m b er  S t a te  or  the  C o m m i s s i on  c o n s i d e rs  that 

the  h a r m o n i z ed  s t a n d a r ds  r e f e r r ed  to  in  A r t i c le  5 ( 1)  do 

not  e n t i r e ly  s a t i s fy  the  e s s e n t i al  h e a l th  and  s a f e ty 

r e q u i r e m e n ts  u n d er  A r t i c le  3,  the  C o m m i s s i on  or 

the 

M e m b er  S t a te  shall  s u b m it  the  m a t t er  to  the  S t a n d i ng 

C o m m i t t e e,  h e r e i n a f t er  c a l l ed  "the  C o m m i t t e e ",  set  up 

u n d er 

D i r e c t i ve 

8 3 / 1 8 9 / E E C, 

g i v i ng 

the 

r e a s o ns 

t h e r e f o r e. 

The 

C o m m i t t ee 

shall 

d e l i v er 

an 

o p i n i on 

w i thout  de I ay . 

In  the  light  of  the  C o m m i t t e e 's  o p i n i o n,  the  C o m m i s s i on 

shall 

Inform  the  M e m b er  s t a t es  w h e t h er  or  not 

It  is 

n e c e s s a ry  to  w i t h d r aw  the  s t a n d a r ds  In  q u e s t i on 

from 

the  list  of  p u b l i c a t i o ns  r e f e r r ed  to  in  A r t i c le  5 ( 1 ). 

A f t er 

r e c e i pt 

of 

the  c o m m u n i c a t i on 

r e f e r r ed 

to 

In 

A r t i c le 

5 ( 2 ), 

the 

C o m m i s s i on 

shall 

c o n s u lt 

the 

C o m m i t t e e.  On  the  b a s is  of  the  C o m m i t t e e 's  o p i n i o n,  the 

C o m m i s s i on 

shall 

inform  the  M e m b er 

S t a t es  w i t h in 

a 

s p e c i f i ed 

p e r i od 

w h e t h er 

or 

not 

c o n f o r m i ty 

can 

be 

-  25 

p r e s u m ed 

in  the  case  of  the  national  s t a n d a r ds  in 

q u e s t i on  and  whether  -  should  this  be  the  case  -  a  list 

of  the  s o u r c es  from  which  such  s t a n d a r ds  are  a v a i l a b le 

should  be  published  at  national  level.  The  C o m m i s s i on 

shall  also  publish  them  in  the  Official  Journal  of  the 

E u r o p e an  C o m m u n i t i e s. 

Art Icle  7 

1. 

W h e re  a  Member  State  a s c e r t a i ns  that  equipment  and 

p r o t e c t i ve  systems  to  which  the  C E - c o n f o r m I ty  mark 

has  been  affixed 

c o r r e c t ly  installed,  m a i n t a i n ed  and 

used 

In 

a c c o r d a n ce 

with 

their 

intended 

p u r p o se 

J e o p a r d i ze 

the 

safety 

of 

p e r s o n s, 

and 

where 

a p p r o p r i a t e,  d o m e s t ic  a n i m a ls  or  p r o p e r t y,  It  shall 

take 

all 

a p p r o p r i a te 

m e a s u r es 

to 

w i t h d r aw 

such 

e q u i p m e nt  and  p r o t e c t i ve  s y s t e ms 

from  the  market  or  to 

prohibit  or  restrict  its  placing  on  the  market  or  the 

putting  Into  s e r v i c e. 

The 

Member 

State 

shall 

Immediately 

Inform 

the 

C o m m i s s i on  of  any  such  m e a s u r e,  indicating  the  reasons 

for 

its  decision  and, 

in  p a r t i c u l a r,  whether 

non 

c o n f o r m i ty  Is  due  to: 

(a) 

n o n - c o m p l i a n ce  with  the  essential 

r e q u i r e m e n ts 

referred  to  In  A r t i c le  3,  where  the  equipment  or 

the  p r o t e c t i ve  system  does  not  comply  with  the 

s t a n d a r ds  referred  to  In  A r t i c le  5 ( 1 ); 

(b) 

Incorrect  a p p l i c a t i on  of  the  s t a n d a r ds  referred 

to  in  Art le le  5(1 ) ; 

(c) 

s h o r t c o m i n gs 

in  the  s t a n d a r ds  referred 

to  in 

A r t i c le  5(1)  t h e m s e l v e s. 

-  26 .. 

These  measures  are  applicable  until  the  entry  Into 

force  of  the  act  provided  for  In  paragraph  2. 

2. 

The  measures  adopted 

under 

paragraph 

1  shall 

be 

confirmed  and  extended,  possibly  amended,  to  the  whole 

Community  or  repealed  by  an  act  of  the  Commission. 

the 

where 

under 
measures 
However, 
paragraph  1  on  the  ground  of  a  shortcoming  In  the 
standards  provided  for  In  Article  5,  the  procedure  laid 
down  in  Article  6(2)  is  applicable. 

adopted 

were 

If  a  non-conforming  Item  of  equipment  or  protective 
system  bears  the  CE-conformIty  mark,  the  competent 
Member  State  shall  take  appropriate  measures  against 
whomsoever  has  affixed  the  mark  and  shall  Inform  the 
Commission  and  the  other  Member  States  thereof. 

The  Commission  shall  ensure  that  the  Member  States  are 
Informed 
this 
procedure. 

the  application 

results  of 

and 

of 

Chapter  I I 

Conformity  assessment  procedures 

Art icle  8 

conformity 

The 
equipment 
considering,  where  necessary,  those  devices  thereof 
referred  to  In  Article  1(2) 

procedures 

assessment 

of 

3. 

4. 

1. 

_  27 _ 

as  well  as  integrated  protective  systems,  shall  be: 

(a) 

Equipment  group  I and  II, conformity  category  (M) 

1  and  1 

The  manufacturer  or  his  authorised  representative-

established  In  the  Community  must,  In order  to  affix 

the  CE  mark,  at  his  own  choice: 

I) 

follow  the  procedure  relating  to  EC  type 

examination  (set  out  in  Annex  III),  coupled 

withthe 

procedure 

relating 

to 

production 

quality  assurance  (set  out  in  Annex  IV) 

or 

the  procedure  relating  to  product  verification 

(set  out  In Annex  V) 

II) 

follow  the  procedure  relating  to  full  quality 

assurance  Including  design  examination  (set 

out  In Annex  IX). 

(b) 

Equipment  group  I  and  II,  conformity  category 

(M)2  and  2 

The  manufacturer  or  his  authorized  representative 

established  in  the  Community  must,  in order  to  affix 

the  CE-mark,  follow  the  procedure  relating  to  EC 

type  examination  (set  out  in  Annex  III),  coupled 

wi th: 

-the  procedure  relating  to  conformity  to  type  (set 

out  In  Annex  VI) 

or 

the  procedure  relating  to  product  quality  assurance 

(set  out  In Annex  VII) 

-  28  -

(c) 

Equipment  group  11,  c o n f o r m i ty  c a t e g o ry  3 

The  m a n u f a c t u r er  or  his  authorized  r e p r e s e n t a t i ve 

e s t a b l i s h ed  in  the  Community  m u s t,  in  order  to 

affix  the  C E - m a r k,  follow  the  p r o c e d u re  relating 

to  Internal  control  of  p r o d u c t i on  (set  out  In 

Annex  V I M ). 

(d) 

EC  uni t  ver IfI cat ion 

The  m a n u f a c t u r er  or  his  authorized  r e p r e s e n t a t i ve 

e s t a b l i s h ed 

in  the  Community  can,  In  order  to 

affix  the  C E - m a r k,  follow  the  p r o c e d u re  relating 

to  EC  unit  v e r i f i c a t i on  (set  out  In  Annex  X ). 

2. 

The  p r o v i s i o ns  of  1(b)  or  1(d)  above  shall  be  used 

for 

c o n f o r m i ty  assessment  relating  to  a u t o n o m o us  p r o t e c t i ve 

s y s t e m s. 

3. 

The  p r o c e d u r es  referred  to  in  p a r a g r a ph  1  shall  be 

applied 

In  respect  of  c o m p o n e n ts  as  referred  to  in 

A r t i c le  4 ( 2)  with  the  e x c e p t i on  of  the  a f f i x i ng  of  the 

C E - c o n f o r m I ty  m a r k. 

A  d e c l a r a t i on  shall  be  issued  by  the  m a n u f a c t u r er  or 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve 

e s t a b l i s h ed 

In 

the 

Community  a t t e s t i ng  the  conformity  of  the  c o m p o n e n ts 

with  the  p r o v i s i o ns  of  this  D i r e c t i ve  which  apply  to 

them  and  stating  their  c h a r a c t e r i s t i cs  and  how  they 

must 

be 

Incorporated 

into  equipment 

or 

p r o t e c t i ve 

system 

to 

assist 

c o m p l i a n ce 

with 

the 

essential 

r e q u i r e m e n ts  a p p l i c a b le  to  finished  a p p l i a n c e s. 

4. 

D o c u m e n ts  and  c o r r e s p o n d e n ce  relating  to  the  p r o c e d u r es 

under  the  a b o v e m e n t i o n ed  p a r a g r a p hs  shall  be  p r e p a r ed 

in  one  of  the  official  languages  of  the  Member  S t a t es 

in  w h i ch  those  p r o c e d u r es  are  being  applied  or  In  a 

language  accepted  by  the  notified  b o d y. 

-  29  -

W h e re  the  e q u i p m e nt  and  p r o t e c t i ve  s y s t e ms  are  subject 

to  other  C o m m u n i ty  D i r e c t i v es  c o n c e r n i ng  o t h er  a s p e c t s, 

the  C E - c o n f o r m l ty  m a rk  r e f e r r ed  to  in  A r t i c le  10  shall 

indicate 

In 

these 

c a s es 

that 

the 

e q u i p m e nt 

and 

p r o t e c t i ve  s y s t e ms  a l so  fulfil  the  p r o v i s i o ns  w h i ch 

apply  to  them  of  the  other  D i r e c t i v e s. 

A r t I c le  9 

1. 

Member  S t a t es  shall  n o t i fy  the  other  M e m b er  S t a t es  and 

the  C o m m i s s i on  of  the  b o d i es  w h i ch  they  have  a p p r o v ed 

for  p e r f o r m a n ce  of  the  t a s ks  in  c o n n e c t i on  w i th  the 

p r o c e d u r es  under  A r t i c le  8  and  the  s p e c i f ic  t a s ks  for 

w h i ch  the  b o d i es  have  been  a p p r o v e d.  In  this  D i r e c t i ve 

these  b o d i es  are  r e f e r r ed  to  as  " n o t i f i ed  b o d i e s ". 

The  C o m m i s s i on  shall  p u b l i sh  a  list  of  the  n o t i f i ed 

b o d i es 

In 

the 

O f f i c i al 

Journal 

of 

the 

E u r o p e an 

C o m m u n i t i es  c o m p r i s i ng  the  I d e n t i f i c a t i on  number  w h i ch 

has  been  a l l o c a t ed  to  them  as  well  as  the  t a s ks  for 

w h i ch  they  have  been  a p p r o v e d . T he  C o m m i s s i on  s h a l l . be 

r e s p o n s i b le  for  u p d a t i ng  that  list. 

2. 

M e m b er  S t a t es  shall  apply  the  m i n i m um  c r i t e r ia  set  out 

in  Annex  XII  for  the  d e s i g n a t i on  of  b o d i e s.  B o d i es  that 

s a t i s fy  the  c r i t e r ia  fixed  by  the  r e l e v a nt  h a r m o n i z ed 

s t a n d a r ds  shall  be  p r e s u m ed  to  s a t i s fy  the  relevant 

m i n imum  cr I ter i a. 

3. 

A  Member  S t a te  w h i ch  has  a p p r o v ed  a  body  shall  w i t h d r aw 

such  a p p r o v al  w h e re  the  body  no  longer  f u l f i l ls  the 

c r i t e r ia  under  p a r a g r a ph  2.  It  shall  I m m e d i a t e ly  Inform 

the  other  Member  S t a t es  and  the  C o m m i s s i on  t h e r e o f. 

-  30  -

The 

n o t i f i ed 

body 

and 

the 

m a n u f a c t u r er 

or 

his 

a u t h o r i s ed 

r e p r e s e n t a t i ve 

e s t a b l i s h ed 

w i t h in 

the 

C o m m u n i ty  shall  agree  on  the  p r o c e d u r es  and  the  time 

limit 

for 

the 

e x e c u t i on 

and 

c o m p l e t i on 

of 

the 

e v a l u a t i on  and  v e r i f i c a t i on  o p e r a t i o ns  r e f e r r ed  to  in 

the  A n n e x e s. 

Chapter  1 I I 

C o n f o r m i ty  m a r ks 

Art icle  10 

1. 

The  C E - c o n f o r m i ty  mark 

as  well 

as  the 

a d d i t i o n al 

s p e c i f ic  m a r k i ng  as  shown  In  Annex  XI  shall  be  affixed 

to  the  e q u i p m e nt 

and  the  p r o t e c t i ve  system  and  as  far 

as  f e a s i b le  and  a p p r o p r i a te  on  the  s a l es  p a c k a g i ng  as 

well 

as  on  the 

Instruction 

leaflet 

in  a  v i s i b l e, 

legible  and  Indelible  form. 

The  C E - c o n f o r m I ty  mark  must  be  a c c o m p a n i ed 

by 

the 

I d e n t i f i c a t i on  number  of  the  n o t i f i ed  body  r e s p o n s i b le 

for  I m p l e m e n t a t i on  of  the  p r o c e d u r es  set  out  In  A n n e x es 

IV,  V,  V I,  V I I,  IX,  X  as  well  as  the  two  last  d i g i ts  of 

the  year  In  which  the  mark  was  a f f i x e d. 

2. 

It 

is 

p r o h i b i t ed 

to 

affix 

any 

other 

m a rk 

or 

i n s c r i p t i o ns 

which 

may 

be 

c o n f u s ed 

with 

the 

C E-

c o n f o r m l ty  mark  or  the  additional  s p e c i f ic  m a r k i ng  set 

out  In  Annex  X I. 

-  31  -

Art Icle  11 

If  any  Member  or  n o t i f i ed  body  finds  that  the  C E - c o n f o r m I ty 

mark 

has 

b e en 

improperly 

a f f i x e d, 

the 

e q u i p m e nt 

or 

p r o t e c t i ve  s y s t em 

c o n c e r n ed  shall  be  p r o h i b i t ed  or  shall  no 

longer  be  m a r k e t e d. 

C h a p t er  IV 

F InaI  provI s Ions 

A r t I c le  12 

Any 

d e c i s i on 

taken 

p u r s u a nt 

to 

this 

D i r e c t i ve 

w h i ch 

r e s t r i c ts  or  p r o h i b i ts  the  p l a c i ng  on  the  m a r k et  a n d / or  the 

p u t t i ng  into  s e r v i ce  or  Imposes  the  retreat  from  the  m a r k et 

of  an  e q u i p m e nt  or  a  p r o t e c t i ve  system  shall  s t a te  the  exact 

g r o u n ds  on  w h i ch 

It  is  b a s e d.  Such  a  d e c i s i on  shall  be 

n o t i f i ed  f o r t h w i th  to  the  party  c o n c e r n e d,  w ho  shall  at  the 

same  time  be  Informed  of  the  legal  rented I es  ava I I ab le  to  him 

under  the  laws  In  force  In  the  Member  State  c o n c e r n ed  and  of 

the  time  limits  to  w h i ch  such  r e m e d i es  are  s u b j e c t. 

Art icle  13 

M e m b er  S t a t es  shall  e n s u re  that  all  the  p a r t i es  involved  In 

the  a p p l i c a t i on 

of 

the  D i r e c t i ve 

are  bound 

to 

o b s e r ve 

c o n f i d e n t i a l i ty  in  respect  of  all  the  i n f o r m a t i on  o b t a i n ed 

in  c a r r y i ng  out 

their 

t a s k s.  T h is  d o es  not  a f f e ct 

the 

o b l i g a t i o ns  of  the  M e m b er  S t a t es  and  of  the  n o t i f i ed  b o d i es 

r e g a r d i ng 

mutual 

i n f o r m a t i on 

and 

the 

d i s s e m i n a t i on 

of 

w a rn i n g s. 

-  32 -

Art Icle  14 

1. 

Directive  76/117/EEC*1>  and  Directive  79/196/EEC<2>, 
as  last  amended  by  Directive  90/487/EEC(3)  as  well  as 
Directive  82/130/EEC<4>  as  last  amended  by  Directive 
91/269/EEC<5) shall  be  repealed  as  from  (1  July  1996). 

2. 

However, 

EEC-certificates  of 

conformity 

to  the 

harmonized  standards  obtained  in  accordance  with  the 

procedures  as  laid  down  in  the  DI rect I ves  referred  to 

In  the  preceding  paragraph  shall  be  valid  until  31 
December  2002.  Their  validity  shall  be  limited  to  only 

those  harmonized  standards  indicated  in  the  said 

D I rectIves. 

3. 

Member  States  shall  take  the  necessary  action  to ensure 
that  the  notified  bodies which  are  responsible  pursuant 
to  Article  8(1)  to  (4)  for  the  assessment  of  the 
conformity  of  electrical  equipment  already  placed  on 
the  market  prior  to  the  coming  Into  force  of  this 
Directive  shall  take  account  of  the  results  of  tests 
and  verifications  already  carried  out  under  the 
Directives  referred  to  In paragraph  1. 

ArtIcle  15 

1. 

Before  [31  December  1992],  Member  States  shall  adopt 
and  publish  the  laws,  regulations  and  administrative 
provisions  necessary  in  order  to  comply  with  this 
Directive.  They  shall  forthwith  inform  the  Commission 
thereof . 

(1)  OJ  No L 24, 31.1.1976 

(2)  OJ  No L 43, 20.2.1979 

(3)  OJ  No L 270,  2.10.1990 

(4)  OJ  No L 59,  2.3.1982 

(5)  OJ  NO L 134, 29.5.1991 

-  33  -

When  Member  States  adopt  these  m e a s u r e s,  they  shall 
contain  a  reference  to  this  Directive  or  shall  be 
accompanied  by  such  reference  on  the  occasion  of  their 
official  publication.  The  methods  of  making  such  a 
reference  shall  be  laid  down  by  the  Member  S t a t e s. 
They  shall  apply  these  provisions  with  effect  from  [1 
July  1993.] 

2. 

However»  Member  States  shall  allow  for  the  period  until 
[31  December  2 0 0 2 ],  the  placing  on  the  market  and  the 
protective 
putting 
systems  In  conformity  with  the  national  regulations  In 
force  In  their  territory  at  the  date  of  adoption  of 
this  dlrectlve. 

Into  service 

equipment 

and 

of 

Art Icle  16 

This  Directive  Is  addressed  to  the  Member  S t a t e s. 

Done  at  B r u s s e l s, 

For  the  CounciI 

The  President 

-  34  -

ANNEX  I 

CRITERIA  DETERMINING  THE  CLASSIFICATION  OF  EQUIPMENT-GROUPS 

INTO  CONFORMITY  CATEGORIES 

1 • 

Equipment-group  I 

a) 

Conformity  category  (M)  1  comprises  equipment  designed 

and,  where  necessary, 

additionally 

equipped 

with 

special  protective  features  to  be  capable  of  keeping 

within 

its  operational 

parameters 

stated 

by 

the 

manufacturer  and  provide  a  high  level  of  protection 

for  Its  Intended  use  in  underground  parts  of  mines  as 

well  as  those  parts  of  surface  Installations  of  such 

mines  endangered  by  firedamp  and/or  combustible  dust. 

Equipment  of  this  category  Is  required  to  remain 

functional 

for  safety 

reasons  with  an 

explosive 

atmosphere  present  and,  by  virtue  of  this,  it  Is 

characterized 

by 

Integrated 

explosion 

protection 

measures  functioning  Independently  of  each  other  in 

such  a  way  that 

In  the  event  of  failure  of  one  integrated  measure  at 

least  a  second  means  of  protection  provides  for  a 

sufficient  level  of  safety  or 

In  the  event  of  two  faults  occurring  Independently 

of  each  other  a  sufficient  level  of  safety  is 

assured. 

Equipment  relating  to  this  conformity  category  comply 

with  the  supplementary  requirements  referred  to  In 

Annex  II  2.0.1. 

- S o 

fa)  Conformity  category  (M)  2  comprises  equipment  designed 

to  be  capable  of  keeping  within 

its  operational 

parameters  stated  by  the  manufacturer  and  based  on  an 

Increased  level  of  protection  for  Its  Intended  use  In 

underground  parts  of  mines  as  well  as  those  parts  of 

surface  installations  of  such  mines  likely  to  become 

endangered  by  firedamp  and/or  combustible  dust. 

The  protection  measures  relating  to  equipment  of  this 

category  provide  for  a  sufficient  level  of  safety 

during  trouble-free  operation  also  In  the  case  of  more 

severe  operating  conditions  In  particular  arising  from 

rough  handling  and  changing  environmental  conditions. 

Equipment  relating  to  this  conformity  category  comply 

with  the  supplementary  requirements  referred  to  in 

Annex  II  2.0.2. 

2. 

Equipment-group  I I 

a) 

Conformity  category  1  comprises  equipment  designed  to 

be  capable  of  keeping  within  its operational  parameters 

stated  by  the  manufacturer  and  based  on  a  high  level  of 

protection  for  Its  Intended  use  considering  areas  In 

which  explosive  atmospheres  caused  by  gases,  vapours  or 

hazes,  suspended  dust  are  highly  likely  to  occur. 

Equipment 

of 

this 

category 

Is  characterized 

by 

integrated  explosion  protection  measures  functioning 

Independently  of  each  other  In  such  a way  that 

In  the  event  of  failure  of  one  integrated  measure  at 

least  a  second  means  of  protection  provides  for  a 

sufficient  level  of  safety  or 

-  36 -

In the event  of  two  faults occuring  independently of 

each  other  a sufficient  level  of  safety  Is assured. 

Equipment  relating  to  this  conformity  category  comply 

with  the  supplementary  requirements  referred  to  In 

Annex  112.1. 

b) 

Conformity  category  2 

comprises  equipment  designed 

to  be  capable  of  keeping  within  its  operational 

parameters  stated  by  the  manufacturer  and  based  on  an 

increased  level  of  protection  for  its  Intended  use 

considering  areas  in which  explosive  atmosphere  caused 

by gases, vapours or  hazes  are  likely  to occur. 

The  protection  measures  relating  to  equipment  of  this 
category  function  in  such  a  way  to  provide  for  a 
sufficient  level  of  safety  also  in  the  event  of 
operating 
operating 
conditions  which  normally  have  to  be  taken  Into 
account. 

malfunctions 

dangerous 

or 

Equipment  relating  to  this  confomity  category  comply 
with  the  supplementary  requirements  referred  to  in 
Annex  II 2.2. 

c) 

conformity  category  3 
comprises  equipment  designed  to 
be  capable  of  keeping  within  Its  operating  parameters 
stated  by  the  manufacturer  and  based  on  a  normal  level 
of  protection  for  Its  intended  use  considering  areas  In 
which  explosive  atmospheres  caused  by gases, vapours or 
hazes  as well  as  by  raising  of  deposited  dust  are  not 
I Ike ly to occur. 

-  37 -

The  design  of  the equipment  of  this category  provides a 
trouble-free 
sufficient 
operatIon. 

during 

safety 

level 

of 

Equipment  relating  to  this  conformity  category  comply 
with  the  supplementary  requirements  referred  to  In 
Annex  II 2.3. 

-  38  -

ANNEX  I I 

Essential  health  and  safety  r e q u i r e m e n ts  relating  to  the 

design  and  c o n s t r u c t i on  of  equipment  and  p r o t e c t i ve  s y s t e ms 

intended  for  use  In  potentially  explosive  a t m o s p h e r e s. 

P R E L I M I N A RY  O B S E R V A T I O NS 

A. 

State  of  the  art  refers  to  the  technical 

k n o w l e d ge 

commonly  a v a i l a b le  up  to  that  point 

In  time  being 

c o n s i d e r e d,  having  been  proved  In  p r a c t i c e. 

The  technical  k n o w l e d ge  which  can  change  very  rapidly, 

must  be  taken  Into  account  as  far  as  possible  and  be 

utilized  Immediately. 

B. 

For  d e v i c es  referred  to  In  article  1  (2)  the  essential 

r e q u i r e m e n ts  shall  only  apply 

Insofar  as  they  are 

necessary  for  the  safe  functioning  and  o p e r a t i on  of 

these  d e v i c e s. 

1. 

Common  r e q u i r e m e n ts  for  equipment  and  p r o t e c t i ve 

s y s t e ms 

1.0.  General  r e q u i r e m e n ts 

1.0.1 

P r i n c i p l es  of  explosion  safety  integration 

Equipment  and  p r o t e c t i ve  systems  Intended  for  use  In 

p o t e n t i a l ly  e x p l o s i ve  a t m o s p h e r es  must  be  designed 

from  the  point  of  explosion  safety  integration. 

In  this  c o n n e c t i o n,  the  m a n u f a c t u r er 

must 

take 

m e a s u r e s: 

-  39  -

above  a l l,  If  it  Is  p o s s i b l e,  to  prevent 

the 

f o r m a t i on  of  e x p l o s i ve  a t m o s p h e r es  w h i ch  may  be 

p r o d u c ed 

or 

r e l e a s ed 

by 

e q u i p m e nt 

and 

by 

p r o t e c t i ve  s y s t e ms  t h e m s e l v e s; 

to  prevent  the  Ignition  of  e x p l o s i ve  a t m o s p h e r es 

c o n s i d e r i ng  e l e c t r i c al  and  n o n - e l e c t r i c al  s o u r c es 

In  any  c a s e; 

w h e re  an  e x p l o s i on  is  however  likely 

to  o c c u r, 

w h i ch  may  d i r e c t ly  or  Indirectly  e n d a n g er  p e r s o ns 

and/or 

the 

s u r r o u n d i ng 

a r e a, 

to 

halt 

It 

Immediately  and/or  to  limit  the  e f f e c t ed  range  of 

e x p l o s i on  flames  and  e x p l o s i on  p r e s s u r es  to  a 

s u f f i c i e nt  level  of  s a f e t y. 

1.0.2 

Equipment  and  p r o t e c t i ve  s y s t e ms  should  be  d e s i g n ed 

and  m a n u f a c t u r ed 

after  due  a n a l y s is  of 

p o s s i b le 

e r r o rs 

in  order 

to  p r e c l u de  d a n g e r o us 

Incidents 

r e l a t i ng 

to 

e q u i p m e nt 

and 

s y s t e ms 

as 

far 

as 

p o s s Ib ie. 

T h e.  f o r e s e e a b le 

m i s u se  which 

can 

r e a s o n a b ly 

be 

a n t i c i p a t ed  must  be  c o n s i d e r e d. 

1.0.3 

Special  testing  and  m a i n t e n a n ce  c o n d i t i o ns 

Equipment  and  p r o t e c t i ve  s y s t e ms  subject  to  special 

testing  and  m a i n t e n a n ce  c o n d i t i o ns  must  be  d e s i g n ed 

and  c o n s t r u c t ed  with  such  c o n d i t i o ns  in  m i n d. 

1.0.4 

S u r r o u n d i ng  area  c o n d i t i o ns 

Equipment  and  p r o t e c t i ve  s y s t e ms  must  be  so  d e s i g n ed 

and  c o n s t r u c t ed  as  to  be  c a p a b le  of  c o p i ng  with 

f o r e s e e a b le  s u r r o u n d i ng  area  c o n d i t i o n s. 

-  40  -

1.0.5 

A d d i t i o n al  s p e c i f ic  m a r k i n gs 

All  e q u i p m e nt  and  p r o t e c t i ve  s y s t e ms  and  their  main 

c o m p o n e n ts  and  I n s t r u m e n t a t i on  must  be  fully  and 

c l e a r ly  marked  for  the  p u r p o se  of 
I d e n t i f i c a t i on 
r e f e r r ed  to  in  Annex  X I,  In  c a s es  w h e re  this  seems1 

to  be  n e c e s s a ry  for  the  v a l u a t i on  of  safety  a s p e c t s. 

1.0.6 

O p e r a t i ng  I n s t r u c t i o ns 

O p e r a t i ng 

i n s t r u c t i o ns 

for 

the 

e q u i p m e nt 

and 

p r o t e c t i ve  s y s t e ms  which  contain  all  the  Information 

n e c e s s a ry  to  the  safety  must  be  drawn  up  In  one  of 

the  languages  of  the  country  In  which  the  e q u i p m e nt 

and  p r o t e c t i ve  s y s t e ms  are  to  be  used  and  s u p p l i ed 

with  the  equipment  and  the  p r o t e c t i ve  s y s t e ms  so 

that 

it  is  p o s s i b le  to  decide  beyond  any 

doubt 

w h e t h er 

an 

item 

of 

equipment 

In 

a 

s p e c i f i ed 

c o n f o r m i ty  category 

or  a  p r o t e c t i ve  system  can  be 

used  safely  In  the  Intended  area  under  the  o p e r a t i ng 

c o n d i t i o ns  to  be  e x p e c t e d.  Such  I n f o r m a t i on  should 

I n c l u d e,  for  e x a m p l e,  data  relating  to: 

the  e q u i p m e n t - g r o up  and  the  c o n f o r m i ty  c a t e g o ry 

p u t t i ng 

into  s e r v i c e,  m a i n t e n a n c e, 

I n s p e c t i o n, 

s e r v i c e a b i l i ty 

c h e c k s, 

r e p a i r s, 

p e r m i s s i b le 

normal  work  and  adjustment 

electrical  p a r a m e t e r s,  p r e s s u re  or  other  relevant 

limit  va lues ; 

the  highest  surface  t e m p e r a t u r e s; 

w h e re 

n e c e s s a r y, 

special 

c o n d i t i o ns 

of 

u s e, 

including  indications  to  p o s s i b le  m i s u se  which 

e x p e r i e n ce  has  shown  might  o c c u r. 

-  41  -

1.1.  C h a r a c t e r i s t i cs  of  m a t e r i a ls 

1.1.1 

The  m a t e r i a ls  used  for  the  c o n s t r u c t i on  of 

the 

equipment  and  p r o t e c t i ve  s y s t e ms  must  comply  with 

the  r e q u i r e m e n ts  to  prevent  the  o c c u r r e n ce 

of  an 

e x p l o s i on  due  regard  being  paid  to  the  operational** 

f o r e s e e a b le  s t r e s s e s. 

As  far  as  It  Is  f o r e s e e a b le  by  the  m a n u f a c t u r e r,  It 

must  not  be  p o s s i b le  for  any  r e a c t i o ns  to  take  place 

between  the  c o n s t r u c t i on  m a t e r i a ls  used  and 

the 

flammable  m a t e r i a ls  which  could 

Impair 

e x p l o s i on 

protect Ion. 

1.1.2 

When  s e l e c t i ng  suitable  c o m b i n a t i o ns  of  m a t e r i a l s, 

due  account  must  be  taken,  for  e x a m p l e,  of  the 

m a t e r i a l s' 

c o r r o s i on 

b e h a v i o r, 

wear 

r e s i s t a n c e, 

e l e c t r o s t a t ic  c o n d u c t i v i t y,  impact  s t r e n g t h,  ageing 

r e s i s t a n ce  and  the  e f f e c ts  of  v a r i a t i o ns 

In  the 

t e m p e r a t u r e. 

1.2.  Design  and  c o n s t r u c t i on 

1.2.1 

State  of  the  art  In  respect  of  technical  e x p l o s i on 

protect ion. 

Equipment  and  p r o t e c t i ve  systems  must  be  designed 

and  m a n u f a c t u r ed  with  due  regard  to  the  state  of  the 

art  In  respect  of  technical  e x p l o s i on  p r o t e c t i on  so 

that  they  can  be  safely  o p e r a t ed  throughout  their 

f o r e s e e a b le  lifetime. 

1.2.2 

C o m p o n e n ts 

to 

be 

Inserted 

into 

or 

used 

as 

r e p l a c e m e n ts 

in  equipment  and  p r o t e c t i ve 

systems 

must  be  so  designed  and  m a n u f a c t u r ed 

that 

they 

-  42  -

f u n c t i on  safely  for  their 

Intended  p u r p o se  with 

regard 

to 

e x p l o s i on 

p r o t e c t i on 

when 

they 

are 

installed 

In  a c c o r d a n ce  with 

the  m a n u f a c t u r e r 's 

Instruct Ions. 

1.2.3 

E n c l o s ed  equipment  s y s t e ms 

In  the  design  and  c o n s t r u c t i on  of  equipment  which 

may  release  flammable  m a t e r i a ls 

p r o v i s i on  is  to  be 

m a de  w h e re  a p p r o p r i a te  for  s t r u c t u r es  which  are  as 

e n c l o s ed  as  p o s s i b le  in  order  to  prevent  or  limit 

the  formation  of  e x p l o s i ve  a t m o s p h e r e s. 

1.2.4 

P r e v e n t i on  of  leaks 

The  e s c a pe  of  flammable  m a t e r i a ls  from  a p e r t u r es  and 

leaks  in  enclosed  equipment  must  be  p r e v e n t ed  where 

a p p r o p r i a te  so  as  to  e n s u re  that  e s c a p i ng  m i x t u r es 

cannot 

give 

rise 

to 

p o t e n t i a l ly 

e x p l o s i ve 

a t m o s p h e r es  or  dust  d e p o s i t i o ns  as  the  result  of  air 

a c c e ss  o u t s i de  the  e q u i p m e n t. 

The  equipment  must  also  be  sealed  In  a  manner  as 

leaktlght  as  p o s s i b le  In  a c c o r d a n ce  with  the 

state 

of  the  art  at  p o i n ts  w h e re  the  flammable  m a t e r i a ls 

are  Introduced  or  drawn  o f f. 

1.2.5 

P r e v e n t i on  of  dust  d e p o s i t i on 

E q u i p m e nt  and  protect Ive  s y s t e ms  which  are  intended 

to  be  used  In  areas  e x p o s ed  to  dust  must  be  so 

d e s i g n ed 

that 

as 

little 

dust 

as  p o s s i b le 

can 

p r e c i p i t a te 

on 

to 

their 

s u r f a c es 

to 

prevent 

I g n I t I o n s. 

They  must  be  easily  c l e a n a b l e. 

-  43  -

1.2.6 

A p p r o p r i a te  p r o t e c t i ve  a p p l i a n c es 

Equipment  and  p r o t e c t i ve  systems  which  are  a s s u m e d, 

for  e x a m p l e,  to  be  exposed 

to  major 

m e c h a n i c al 

h a z a r ds 

or 

v i b r a t i o ns 

In  normal 

use 

must 

be 

e q u i p p e d,  .  where 

necessary* 

with 

appropriate** 

p r o t e c t i ve  a p p l i a n c e s.  The  equipment  must  w i t h s t a nd 

relevant 

s t r e s s e s, 

without 

adversely 

a f f e c t i ng 

e x p l o s i on  p r o t e c t i o n. 

1.2.7 

Safe  o p e n I ng 

If  equipment  and  p r o t e c t i ve  systems  are  in  a  housing 

or  a  locked  c o n t a i n e r,  it  must  be  p o s s i b le  to  open 

such  housing  or  container  only  with  'tools  or  by 

m e a ns  of  a p p r o p r i a te  p r o t e c t i on  m e a s u r e s. 

1.2.8 

P r o t e c t i on  against  other  hazards 

Equipment  and  p r o t e c t i ve  systems  must  be  d e s i g n ed 

and  m a n u f a c t u r ed  so  as  to  prevent  danger  of  physical 

or 

other 

forms 

of 

Injury 

which 

might 

o c c u r, 

p a r t i c u l a r ly  the  h a z a r ds  arising  from  e l e c t r o c u t i o n. 

W h e r e,  for  equipment  and  p r o t e c t i ve  s y s t e m s,  these 

risks  referred  to  In  this  paragraph  are  w h o l ly  or 

partly  covered  by  other  Community  D i r e c t i v e s,  this 

D i r e c t i ve  shall  not  apply  or  shall  cease  to  a p p l y, 

In  the  case  of  such  equipment  and  p r o t e c t i ve  s y s t e ms 

and  of  such  risks  on  the  entry  into  force  of  these 

s p e c i f ic  D i r e c t i v e s. 

-  44  -

1.3.  Potential  ignition  s o u r c es 

1.3.1 

H a z a r ds  arising  from  different  Ignition  s o u r c es 

Potential  Ignition  s o u r c es  such  as  s p a r k s,  f l a m e s, 

e l e c t r ic  a r c s,  high  surface  t e m p e r a t u r e s, 

n o i s e --

g e n e r a t ed  e n e r g y,  radiation  In  the  optical  field, 

e l e c t r o m a g n e t ic  w a v es  and  other  relevant 

ignition 

s o u r c es  should  not  o c c u r. 

1.3.2 

E l e c t r o s t a t ic  h a z a r ds 

E l e c t r o s t a t ic 

c h a r g es 

capable 

of 

r e s u l t i ng 

In 

d a n g e r o us  d i s c h a r g es  must  be  p r e v e n t ed  by  m e a ns  of 

a p p r o p r i a te  m e a s u r e s. 

1.3.3 

H a z a r ds  arising  from  e l e c t r ic  s t r a y-  and 

leakage 

c u r r e n ts 

E l e c t r ic  s t r a y-  and  leakage  c u r r e n ts  In  c o n d u c t i ve  *' 

e q u i p m e nt  parts  which  could  result  for  e x a m p le  in 

the  o c c u r r e n ce  of 

igniting 

s p a r ks  or 

d a n g e r o us 

c o r r o s i on  must  be  p r e v e n t e d. 

1.3.4 

H a z a r ds  arising  from  o v e r h e a t i ng 

O v e r h e a t i ng 

caused 

by 

friction 

and 

Impacts-

o c c u r r i n g,  for  e x a m p l e,  b e t w e en  m a t e r i a ls  and  parts 

in  contact 

with  each  other 

while  r o t a t i n g, 

by 

intrusion  of  foreign  bodies  and  simlliar  p h e n o m e na 

must  be  p r e v e n t ed  already  at  the  design  stage  as  far 

as  p o s s i b l e. 

1.3.5 

H a z a r ds  arising  from  c o m p r e s s i on  o p e r a t i o ns 

C o m p r e s s i on  o p e r a t i o ns  must  p r o c e ss  In  such  a  way  at 

-  45  -

the 

design 

stage 

r e s p e c t i v e ly 

with 

Integrated 

m e a s u r e m e nt  and  control  d e v i c es  that  they  do  not 

give 

rise 

to  any 

shock  w a v es  and 

c o m p r e s s i o ns 

c a p a b le  of  causing  i g n i t i o n. 

1.4.  H a z a r ds  arising  from  external  e f f e c ts 

1.4.1 

E q u i p m e nt  and  p r o t e c t i ve  s y s t e ms  must  be  so  d e s i g n ed 

and  c o n s t r u c t ed  as  also  to  be  c a p a b le  of  p e r f o r m i ng 

their  intended  f u n c t i on  In  c h a n g i ng  e n v i r o n m e n t al 

c o n d i t i o n s,  under 

the 

influence 

of 

e x t r a n e o us 

v o l t a g e s,  in  the  p r e s e n ce  of  e x c e s s i ve 

h u m i d i t y, 

v i b r a t i o n s,  c o n t a m i n a t i on  and  other  external  e f f e c ts 

w i t h in 

the 

o p e r a t i o n al 

c o n d i t i o ns 

s t a t ed 

by 

m a n u f a c t u r e r s. 

1.4.2 

C o m p o n e n ts 

and 

i n s t r u m e n t a t i on  used 

must 

be 

a p p r o p r i a te  to  the  Intended  m e c h a n i c al  and  thermal 

s t r e s s es  and  c a p a b le  of  w i t h s t a n d i ng  e x i s t i ng  or  to 

be  e x p e c t ed  influences  of  a g g r e s s i ve  m e d i a. 

1.5.  S a f e t y - r e l a t ed  r e q u i r e m e n ts  In  respect  of  e q u i p m e nt 

1.5.1 

R e q u i r e m e n ts  in  respect  of  safety  d e v i c es 

O v e r l o a d i ng  of  e q u i p m e nt 

must  be  p r e v e n t e d, 

for 

e x a m p l e, 

by  m e a ns  of  o v e r c u r r e nt  cut-off  s w i t c h e s, 

t e m p e r a t u re 

l l m l t e r s, 

d i f f e r e n t i al 

p r e s s u re 

s w i t c h e s, 

f l o w m e t e r s, 

time-lag 

r e l a y s, 

speed 

m o n i t o rs  and/or 

similar  types  of  m o n i t o r i ng  d e v i c es 

a l r e a dy 

at 

the 

design 

stage 

r e s p e c t i v e ly 

with 

integrated  m e a s u r e m e nt  and  control  d e v i c e s. 

1.5.2 

Safety  d e v i c es  must  f u n c t i on  i n d e p e n d e n t ly  of  any 

m e a s u r e m e nt 

and 

control 

d e v i c es 

r e q u i r ed 

for 

operat ion. 

-  46  -

A  s a f e ty  d e v i ce  f a i l u re  shall  be  d e t e c t ed  by  m e a ns 

of  approprI ate  m e a s u r es  that  w i t h in  a  short  time 

p e r i od  a  d a n g e r o us  c o n d i t i on  Is  not  h i g h ly  likely  to 

o c c u r. 

For  e l e c t r i c al  c i r c u i ts  the  f a l l - s a fe  p r i n c i p le  Is 

to  be  a p p l i ed  when  the  risks  a s s e s s m e nt  m a k es  this 

n e c e s s a r y. 

If  a p p r o p r i a t e,  the  s a f e t y - r e l a t ed  s w i t c h i ng  must 

d i r e c t ly  Influence  the  relevant  control 

a c t u a t i ng 

d e v i ce  w i t h o ut  s o f t w a re  c o m m a n d. 

1.5.3 

In  the  event  of  a  safety  d e v i ce  f a i l u r e,  e q u i p m e nt 

and/or  p r o t e c t i ve  s y s t e ms  shall  be  put  Into  safe 

c o n d I t I o n. 

1.5.4 

S a f e ty  d e v i c es  should  be  fitted  w h e re  a p p r o p r i a te 

with  restart  l o c k o u t s.  A  new  start  command  may  take 

effect  In  the  case  of  normal  o p e r a t i on  only  after 

the  safety  c u t - o ff  switch  has  i n t e n t i o n a l ly  been 

r e s e t. 

1.5.5 

A p p l i c a t i on  of  e r g o n o m ie  p r i n c i p l es 

W h e re  control  and  d i s p l ay  u n i ts  are  u s e d,  they  must 

be  d e s i g n ed  in  a c c o r d a n ce  with  e r g o n o m ie  p r i n c i p l es 

In  order  to  a c h i e ve  the  highest  p o s s i b le  level  of 

o p e r a t I ng  s a f e t y. 

1.5.6 

R e q u i r e m e n ts 

in 

respect 

of 

e q u i p m e nt 

with 

a 

m e a s u r i ng  f u n c t i on  for  e x p l o s i on  p r o t e c t i o n. 

E q u i p m e nt  with  a  m e a s u r i ng  f u n c t i on  must  be  d e s i g n ed 

and  c o n s t r u c t ed 

in  p a r t i c u l ar 

from  the  point  of 

v i ew  of  their  m e a s u r i ng  p r i n c i p l e s,  d i s p l ay  time 

-  47  -

lag,  t r a n s v e r se  s e n s i t i v i ty 

and  a c c e p t a b le  a c c u r a cy 

limits  so  that  they  can  cope  with  the  f o r e s e e a b le 

s i t u a t i o ns  and  special  c o n d i t i o ns  of  u s e. 

1.5.7 

It  must  be  p o s s i b le  to  check  with  su I tab Ie  devI c e s, 

w h e re 

n e c e s s a r y, 

the 

reading 

a c c u r a cy 

and 

s e r v i c e a b i l i ty 

of 

equipment 

with 

a 

m e a s u r i ng 

f u n c t i o n. 

1.5.8 

The  design  of  equipment  with  a  m e a s u r i ng  f u n c t i on 

must  Incorporate  a  safety  factor  which  e n s u r es  that 

the  alarm  threshold 

lies  far  enough  o u t s i de 

the 

e x p l o s i v i ty 

limits  of 

the 

a t m o s p h e r es 

to 

be 

r e g i s t e r e d. 

1.5.9 

Risks  arising  from  s o f t w a re 

In  the  design  of  s o f t w a r e - c o n t r o l l ed 

e q u i p m e n t, 

special  account  must  be  taken  from  an  analytical 

point  of  view  of  the  risks  arising  from  faults  in 

the 

p r o g r a m m e. 

For 

electrical 

c i r c u i ts 

the 

r e q u i r e m e nt  1.5.2  as  relevant  must  be  a p p l i e d.  The 

same  safety  r e q u i r e m e n ts  apply  to  s e n s o r - m o n i t o r ed 

e q u i p m e n t. 

1 . 

Integration  of  safety  r e q u i r e m e n ts  relating 

to  the 

system 

1.6.1 

Manual  o v e r r i de  of  a u t o m a t ic  p r o c e s s es  must  at  all 

times  be  p o s s i b le  to  avert  h a z a r d s. 

In 

the 

event 

of 

d e v i a t i on 

from 

the 

Intended 

o p e r a t i o n,  It  must  be  p o s s i b le  to  shut  the  e q u i p m e nt 

down  s a f e l y. 

-  48  -

1.6.2 

When  the  emergency  shutdown  system  Is  actuated, 

accumulated  energy  must  be  reduced  as  quickly  and 

safely  as  possible  so  that 

It  will 

lose  Its 

potentially  dangerous  effects. 

This  does  not  apply  for  e I ectrochemIcaI I y  stored 

energy. 

1.6.3 

Hazards  arising  from  power  failure 

Where  equipment  can  give  rise  to  additional  hazards 

In  the  event  of  a  power  failure,  It  must  be 

possible  to  restore  It  to  a  safe  operating  state 

Independently  of  the  rest  of  the  Installation. 

1.6.4 

Hazards  arising  from  connections 

Equipment  and  product I ve  systems  must  be  fitted  with  "<• 

suitable  cable  and  conduit  entries.. 

When  equipment  and  protective  systems  are  Intended 

for  use  In  combination  with  other  equipment  and 

protect Ive  systems,  the  Interface  shall  be  made  in a 

safe  manner. 

1.6.5 

Placing  of  warning  devices  as  parts  of  equipment 

Where  warning  devices  are  provided  for  monitoring 

explosive  atmospheres  In  the  vicinity  of  equipment, 

the  detectors  must  be  capable  of  being  positioned  In 

such  a  way  that  a  dangerous  operatIng  condition  can 

be  readily  identified. 

-  49  -

1.6.6 

Areas  endangered  by  pressure  relief  In  the  event  of 
an  explosion 

Areas  endangered  in  front  of  explosion  pressure-

relief 

devices 

should 

be 

Indicated 

by 

the 

manufacturer  as  far  as  possible. 

-  50  -

2. 

S u p p l e m e n t a ry  r e q u i r e m e n ts  in  respect  of  e q u i p m e nt 

w h i ch  are  c a p a b le  of  c a u s i ng  an  e x p l o s i on 

2.0.  C r i t e r ia  for  c o n f o r m i ty  c a t e g o ry  M  of  e q u i p m e nt  g r o up  I 

2.0.1 

C r i t e r ia  for  c o n f o r m i ty  c a t e g o ry  (M)  1  of  e q u i p m e nt 

g r o up  I 

2.0.1.1  E q u i p m e nt  must  be  so  d e s i g n ed  and  c o n s t r u c t ed  and, 

w h e re  n e c e s s a r y,  a d d i t i o n a l ly  e q u i p p ed  with  special 

p r o t e c t i ve  f e a t u r es  that  s o u r c es  of  Ignition  do  not 

b e c o me  e f f e c t i ve  even  in  the  event  of  rare  Incidents 

r e l a t i ng 

to 

e q u i p m e nt 

or 

two 

faults 

o c c u r I ng 

I n d e p e n d e n t ly  of  each  o t h e r. 

2.0.1.2  E q u i p m e nt  must  be  so  c o n s t r u c t ed  that,  as  far  as  It 

is 

p o s s i b l e, 

no 

dust 

can 

p e n e t r a te 

to 

their 

Interlor . 

2.0.1.3  The  s u r f a ce  t e m p e r a t u r es  of  e q u i p m e nt  p a r ts  must  be 

kept  well  b e l ow  the  Ignition  t e m p e r a t u re  of  the 

f o r e s e e a b le  d u s t / a ir  m i x t u r es  In  order  to  prevent 

the  Ignition  of  s u s p e n d ed  dust  and  be  kept  well 

b e l ow  the  glow  t e m p e r a t u re  In  the  case  of  d e p o s i t ed 

d u s t.  The  t h i c k n e ss  of  d e p o s i t ed  dust  and 

dust 

a c c u m u l a t i on  on  e q u i p m e nt  p a r ts  should  be  taken  Into 

c o n s i d e r a t i on  and  offset  w h e re  a p p r o p r i a te  by  m e a ns 

of  t e m p e r a t u re 

limitation  In  order  to  p r e v e nt  a 

heat  b u i I d - u p. 

2.0.1.4  E q u i p m e nt  must  be  so  d e s i g n ed  that  the  o p e n i ng  of 

e q u i p m e nt  p a r ts  must  be  c a r r i ed  out  only  under  n o n-

a c t i ve 

or 

Intrinsic 

s a f e ty 

c o n d i t i o ns 

or 

via 

relevant  i n t e r l o c k i ng  m e c h a n i s m s. 

-  51  -

2.0.2 

C r i t e r ia  for  c o n f o r m i ty  c a t e g o ry  (M)  2  of 

equipment  group  I 

2.0.2.1  Equipment  must  be  so  designed  and  c o n s t r u c t ed  that 

s o u r c es  of  Ignition  do  not  b e c o me  e f f e c t i ve  during 

t r o u b l e - f r ee  o p e r a t i o n. 

2.0.2.2  If  after  the  o p e n i ng  of  the  e n c l o s u r e,  the  e x p o s u re 

of  c o m p o n e n ts  could  lead  to  the  Ignition  of  an 

e x p l o s i ve  a t m o s p h e r e,  it  must  only  be  p o s s i b le  to 

open  equipment  under  n o n - a c t i ve  c o n d i t i o ns  or  via 

relevant  Interlocking  m e c h a n i s m s. 

2.0.2.3  The 

r e q u i r e m e n ts 

regarding 

e x p l o s i on 

h a z a r ds 

o c c u r r i ng 

from 

dust 

referred 

to 

in 

c o n f o r m i ty 

category  (M)  1  must  be  a p p l i e d. 

2.1 . 

C r i t e r ia  for  c o n f o r m i ty  c a t e g o ry  1  of  equipment 

group  I I 

2 . 1 . 1.  E x p l o s i ve  a t m o s p h e r es  caused  by  g a s e s,  v a p o u rs  or 

hazes 

2.1.1.1  Equipment  must  be  so  designed  and  c o n s t r u c t ed  that 

s o u r c es  of  Ignition  do  not  occur  even  in  the  event 

of  rare 

Incidents  relating  to  equipment  or 

two 

faults  o c u r r i ng  Independently  of  each  o t h e r. 

2.1.1.2  Equipment  with  s u r f a c es  that  are  likely  to  heat  up 

should  be  avoided  where  p o s s i b l e.  Falling  t h i s,  it 

must  be  ensured  that  the  stated  m a x i m um 

surface 

t e m p e r a t u r es  In  even  the  most  u n f a v o u r a b le  cases 

remain  s a f e l y.  In  this  c o n n e c t i o n,  t e m p e r a t u re  rises 

caused  by  heat  b u i l d - u ps  and  chemical  r e a c t i o ns  must 

also  be  taken  into  a c c o u n t. 

-  52  -

2.1.1.3  Equipment  must  be  so  designed  that  the  o p e n i ng  of 

equipment  parts  must  be  carried  out  only  under  n o n-

a c t i ve 

or 

Intrinsic 

safety 

c o n d i t i o ns 

or 

via 

relevant  interlocking  m e c h a n i s m s. 

2 . 1 . 2.  E x p l o s i ve  a t m o s p h e r es  caused  by  dust 

.  ^ „. 

2.1.2.1  Equipment  must  be  so  designed  and  c o n s t r u c t ed  that 

Ignition  of  e x i s t i ng  dust/air  m i x t u r es  do  not  occur 

even  in  the  event  of  rare  incidents  relating  to 

equipment  and  two  faults  o c c u r I ng  independently  of 

each  o t h e r. 

2.1.2.2  Equipment  must  be  so  c o n s t r u c t ed  that  as  far  as  It 

is 

p o s s i b l e, 

no 

dust 

can 

p e n e t r a te 

to 

their 

i n t e r l o r s. 

This  requirement  must  also  be  met  by  inlet  and 

c o n n e c t i ng  p i e c e s. 

2.1.2.3  The  s u r f a ce  t e m p e r a t u r es  of  e q u i p m e nt  p a r ts  must  be 

kept  well  below  the  Ignition  t e m p e r a t u re  of  the 

f o r e s e e a b le  dust/air  m i x t u r es  In  order  to  prevent 

the  ignition  of  suspended  dust  and  be  kept  well 

below  the  glow  temperature  in  the  case  of  deposited 

d u s t.  The  t h i c k n e ss  of  d e p o s i t ed  dust  and  dust 

a c c u m u l a t i on  on  equipment  parts  should  be  taken  into 

c o n s i d e r a t i on  and  offset  w h e re  approprI ate  by  m e a ns 

of  t e m p e r a t u re  limitation  In  order  to  prevent  a  heat 

buI Id-up. 

2.1.2.4  The  requirement  2.1.1.3  regarding  the  safe  o p e n i ng 

of  equipment  for  c o n f o r m i ty  category  1  also  a p p l i es 

h e r e. 

-  53  -

2.2. 

Criteria  for  conformity  category  2  of  equipment 

group  " 

2.2.1.  Explosive  atmospheres  caused  by  gases,  vapours  or 

hazes 

2.2.1.1  Equipment  must  be  designed  and  constructed  to 

prevent 

Ignition, 

including 

those 

caused 

by 

frequently  occurring  incidents  relating  to  equipment 

which  normally  have  to  be  taken  into  account. 

2.2.1.2  Equipment  parts  must  be  so  designed  and  constructed 

that  their  stated  surface  temperatures  to  be  kept 

safely  even  where  risks  arise  from  foreseeable 

abnormal  situations. 

2.2.1.3  If  after  the  opening  of  the  enclosure,  the  exposure 

of  components  could  lead  to  the  Ignition  of  an 

explosive  atmosphere,  equipment  must  be  constructed 

so  that  it  must  only  be  possible  to  open  equipment 

under 

non-active 

conditions 

or 

via 

relevant 

Interlocking  mechanisms. 

2.3 

Criteria*  for  conformity  category  3  of  equipment 

flrouP  '' 

2.3.1.  Explosive  atmospheres,  caused  by  gases,  vapours  or 

hazes 

2.3.1.1  Equipment  must  be  so  designed  and  constructed  to 

prevent  Ignitions  which  can  occur  during  trouble-

free  operatIon. 

-  54  -

2.3.1.2  The  surface  temperatures  may  not  exceed  Ignition 

temperatures 

during 

Intended 

operations. 

Temperatures  in  excess  of  Ignition  temperatures  may 

be  allowed  only  If  special  protective  measures  are 

taken  by  the  manufacturer. 

2.3.2.  Explosive  atmospheres  caused  by  dust 

2.3.2.1  Equipment  must  be  so  designed  and  constructed  that 

suspended  dust  cannot  be  Ignited  by  Ignition  sources 

likely  to  exist  under  normal  operating  conditions. 

The  possibility  of  ignition  of  deposited  dust  during 

rarely  occurring  Incidents  relating  to  equipment  and 

faults  must  also  be  precluded. 

2.3.2.2  The 

requirement 

2.1.2.3 

regarding 

surface 

temperatures  for  conformity  category  1  also  applies 

here. 

2.3.2.3  Equipment  Including  the  Inlet  parts  and  connecting 

pieces  thereof,  must  be  so  constructed  that  dust 

cannot 

penetrate 

and 

It 

is 

impossible 

for 

potentially  explosive  dust/air  mixtures  to  develop 

or  dangerous  dust  deposition  to  occur  Inside  It. 

-  55  -

3. 

S u p p l e m e n t a ry  r e q u i r e m e n ts  In  respect  of  p r o t e c t i ve 

systems 

3.0.  General  r e q u i r e m e n ts 

3.0.1 

P r o t e c t i ve 

systems 

Intended 

to 

halt 

Incipient 

e x p l o s i o ns  and/or  to  limit  the  effected  range  of 

explosion  flames  and  explosion  p r e s s u r es  must  be 

integrated  where  necessary  into  equipment  and  be  so 

designed 

that 

those 

e f f e c ts 

are 

limited 

to  a 

sufficient  level  of  s a f e t y. 

3.0.2 

The  p r o t e c t i ve  systems  must  be  so  designed 

and 

capable  of  being  positioned  that  It  is  possible  to 

prevent  e x p l o s i o ns  from  spreading 

through  d a n g e r o us 

chain 

reactions 

and 

f l a s h o v er  -and 

halt 

the 

transition  of  Incipient  e x p l o s i o ns  to  d e t o n a t i o n s. 

3.0.3 

In  the  event  of  a  power  fa ilure,  p r o t e c t i ve  systems-

must 

retain 

their 

capacity 

to  function 

for 

an 

adequate*- per lod  to  avoid  a  d a n g e r o us  s i t u a t i o n. 

3.0.4 

P r o t e c t i ve 

systems 

shall 

not 

fail 

under 

the 

Influence  of  external  e f f e c t s. 

-  56  -

3.1.  P l a n n i ng  and  d e s i gn 

3.1.1 

S t r e n g th  of  m a t e r i a ls 

At  the  p l a n n i ng  s t a g e,  the  s t r e n g th  r e q u i r ed  of  the 

m a t e r i a ls  must  be  d e t e r m i n ed  on  the  b a s is  of  the 

m a x i m um 

e x p l o s i on 

p r e s s u re 

being 

the 

e x p l o s i on 

p r e s s u re 

to 

be 

e x p e c t e d, 

c o n s i d e r i ng 

a l so 

the 

a n t i c i p a t ed 

heating 

effect 

of 

the 

flame 

under 

e x t r e me  o p e r a t i ng  c o n d i t i o n s. 

3.1.2 

P r o t e c t i ve  s y s t e ms  d e s i g n ed 

to  resist 

e x p l o s i o ns 

must  be  c a p a b le  of  w i t h s t a n d i ng  the  p r e s s u re  w a ve  In 

q u e s t i on  with  a d e q u a te  c e r t a i n t y. 

3.1.3 

The  a c c e s s o r i es  c o n n e c t ed  to  the  p r o t e c t i ve  s y s t e ms 

must  be  c a p a b le  of  w i t h s t a n d i ng  the  e x p e c t ed  m a x i m um 

e x p l o s i on  p r e s s u re  without  losing  their  c a p a c i ty  to 

funct ion. 

3.1.4 

F l a m e p r o of  e n c l o s u re  s y s t e ms 

.  If  p a r ts  w h i ch  can  Ignite  an  e x p l o s i ve  a t m o s p h e re 

are  placed  In  an  e n c l o s u r e,  it  must  be  Insured  that 

the  e n c l o s u re  can  w i t h s t a nd  the  p r e s s u re  d e v e l o p ed 

during  an  internal  e x p l o s i on  of  an  e x p l o s i ve  m i x t u re 

and  p r e v e n ts  the  t r a n s m i s s i on  of  the  e x p l o s i on  to 

the  e x p l o s i ve  a t m o s p h e re  s u r r o u n d i ng  the  e n c l o s u r e. 

3.1.5 

T a k i ng  account  of  system  r e a c t i o ns 

The  r e a c t i o ns  caused  -by  p r e s s u r es 

In  p e r i p h e r al 

e q u i p m e nt  and  c o n n e c t ed  p i p e w o rk  must  be  taken  into 

c o n s i d e r a t i on 

In 

the 

p l a n n i ng 

and 

d e s i gn 

of 

p r o t e c t i ve  s y s t e m s. 

-  57  -

3.1.6 

P r e s s u r e - r e l i ef  s y s t e ms 

If  it  Is  likely  that  s t r e s s es  on  p r o t e c t i ve  s y s t e ms 

will  exceed  their  s t r u c t u r al 

s t r e n g t h, 

p r o v i s i on 

must  be  made  In  the  d e s i gn  for  s u i t a b le  p r e s s u r e-

relief  d e v i c es  which  do  not  e n d a n g er  p e r s o ns  in  the 

v i c i n i t y. 

3.1.7 

E x p l o s i on  s u p p r e s s i on  s y s t e ms 

E x p l o s i on  s u p p r e s s i on  s y s t e ms  must  be  so  p l a n n ed  and 

d e s i g n ed  that  they  react  to  an  Incipient  e x p l o s i on 

at  the  earliest  p o s s i b le  s t a ge  in  the  event  of  an 

incident  and  c o u n t e r a ct  it  to  best  effect  with  due 

regard  to  the  m a x i m um  rate  of  p r e s s u re  increase  and 

the  m a x i m um  e x p l o s i on  p r e s s u r e. 

3.1.8 

E x p l o s i on  d e c o u p l i ng  s y s t e ms 

DecoupI Ing  s y s t e ms  Intended  to  d i s c o n n e ct 

rapidly 

a s s i g n ed  e q u i p m e nt  In  case  of  Incipient  e x p l o s i o ns 

by  m e a ns  of  special  a p p l i a n c es  must  be  so  p l a n n ed 

.and  d e s i g n ed  that  they  remain  proof  a g a i n st  n o n-

t r a n s m i s s i on  of  an 

internal 

ignition  and 

retain 

their 

'mechanical 

s t r e n g th 

under 

o p e r a t i o n al 

c o n d 1 1 I o ns . 

3.1.9 

P r o t e c t i ve 

s y s t e ms 

must 

be 

c a p a b le 

of 

being 

integrated 

into  a  circuit  with  a  s u i t a b le  alarm 

t h r e s h o ld  so  that,  If  n e c e s s a r y,  there  Is 

c e s s a t i on 

of  product  feed  and  output.'ând  immediate  s h u t d o wn  of 

e q u i p m e nt  p a r ts  which  can  no  longer  f u n c t i on  s a f e t y. 

-  58  -

ANNEX  I I I 

M o d u l e:  EC  t y p e - e x a m l n i a t i on 

1. 

T h is  m o d u le  d e s c r i b es  that  part  of  the  p r o c e d u re  by 

w h i ch  a  n o t i f i ed  body  a s c e r t a i ns  and  a t t e s ts  that  a 

s p e c i m e n,  r e p r e s e n t a t i ve  of  the  p r o d u c t i on  e n v i s a g e d, 

m e e ts  the  relevant  p r o v i s i o ns  of  the  D i r e c t i v e. 

2. 

The  a p p l i c a t i on  for  the  EC  t y p e - e x a m i n a t i on  shall  be 

lodged 

by 

the 

m a n u f a c t u r er 

or 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve  e s t a b l i s h ed  w i t h in  the  C o m m u n i ty  with  a 

n o t i f i ed  body  of  his  c h o i c e. 

The  a p p l i c a t i on  shall  i n c l u d e: 

the  n a me  and  a d d r e ss  of  the  m a n u f a c t u r er  and,  If  the  -

a p p l i c a t i on  Is  lodged  by  the  author I zed  r e p r é s e n t ât I v e, 

his  n a me  and  a d d r e ss  in  a d d i t i o n; 

a  w r i t t en  d e c l a r a t i on  that  the  same  a p p l i c a t i on  has  not  * 

been  lodged  with  any  other  n o t i f i ed  b o d y; 

.^-» 

the  technical  d o c u m e n t a t i o n,  as  d e s c r i b ed  In  point  3. 

The  a p p l i c a nt  shall  place  at  the  disposal  of  the.  n o t i f i ed 

body  a  s p e c i m e n,  r e s p r e s e n t a t I ve  of  the  p r o d u c t i on  e n v i s a g ed 

and  h e r e i n a f t er  called  " t y p e ".  The  n o t i f i ed  body  may  request 

further 

s p e c i m e ns 

if  needed 

for  c a r r y i ng  out 

the  test  -

p r o g r a m m e. 

3. 

The  technical  d o c u m e n t a t i on  shall  e n a b le  the  c o n f o r m i ty 

of  the  product  with  the  r e q u i r e m e n ts  of  the  D i r e c t i ve 

to  be  a s s e s s e d.  It  s h a l l,  as  far  as  relevant  for  such 

a s s e s s m e n t,  cover  the  d e s i g n,  m a n u f a c t u re  and  o p e r a t i on 

of  the  p r o d u ct  and  shall  c o n t a in  as  far  as  Is  relevant 

for  a s s e s s m e nt : 

-  59  -

a  general  t y p e - d e s c r i p t i o n; 

conceptual  design  and  m a n u f a c t u r i ng  d r a w i n gs  and 

s c h e m es  of  c o m p o n e n t s,  s u b - a s s e m b l i e s, 

c i r c u i t s, 

e t c. ; 

d e s c r i p t i o ns 

and  e x p l a n a t i o ns  n e c e s s a ry 

for 

the 

u n d e r s t a n d i ng  of  said  d r a w i n gs  and  s c h e m es  and  the 

o p e r a t i on  of  the  p r o d u c t; 

a  list  of  the  s t a n d a r ds  referred  to  in  A r t i c le  5, 

applied  in  full  or  In  p a r t,  and  d e s c r i p t i o ns  of  the 

s o l u t i o ns  adopted  to  meet  the  essential  r e q u i r e m e n ts 

of  the  D i r e c t i ve  where  the  s t a n d a r ds  referred  to  in 

A r t i c le  5  have  not  been  a p p l i e d; 

r e s u l ts  of  design  c a l c u l a t i o ns  m a d e,  e x a m i n a t i o ns 

carried  out,  e t c .; 

test  r e p o r t s. 

4. 

The  notified  body  sha 

4.1 

e x a m i ne  the;  techn l cal  -documentât Ion ,  verify  that,  the 

type  has  been  m a n u f a c t u r ed 

in  c o n f o r m i ty  with 

the 

technical  document at I on * and  Identify  the  e l e m e n ts  which 

have  been  designed  In  a c c o r d a n ce  with  the  relevant 
p r o v i s i o ns  of  the  s t a n d a r ds  referred  to  In  A r t i c l e ^ ,1 

as  well  as  the  c o m p o n e n ts  which  have  been  designed 

without 

applying 

the  relevant 

p r o v i s i o ns  of 

those 

s t a n d a r d s; 

4.2  perform  or  have  performed  the  a p p r o p r i a te  e x a m i n a t i o ns 

and 

n e c e s s a ry 

tests 

to  check 

w h e t h e r, 

w h e re 

the 

s t a n d a r ds  referred  to  in  A r t i c le  5  have  not 

been 

a p p l i e d,  the  s o l u t i o ns  a d o p t ed  by  the  m a n u f a c t u r er 

meet  the  essential  r e q u i r e m e n ts  of  the  Directive-, 

4.3  perform  or  have  performed  the  a p p r o p r i a te  e x a m i n a t i o ns 

and 

n e c e s s a ry 

tests 

to  check 

w h e t h e r, 

w h e re 

the 

m a n u f a c t u r er 

has 

chosen 

to 

apply 

the 

relevant 

s t a n d a r d s,  these  have  actually  been  a p p l i e d; 

-  60  -

4.4  agree  with  the  applicant  the  location  where  the 

examinations  and  necessary  tests  shall  be  carried  out. 

5. 

Where  the  type  meets  the  relevant  provisions  of  the 

Directive,  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 

examlnI at ion, 

conditions  for  Its  validity  and  the  necessary  data  for 

Identification  of  the  approved  type. 

A  list  of  the  relevant 

parts  of  the 

technical 

documentation  shall  be  annexed  to  the  cert IfIcate  and  a 

copy  kept  by  the  notified  body. 

If  the  manufacturer  or  his  authorized  representative 

established 

in  the  Community 

Is  denied 

a 

type 

certification,  the  notified  body  shall  provide  detailed 

reasons  for  such  denial. 

Provision  shall  be  made  for  an  appeals  procedure. 

6. 

The  applleant  shal I  Inform  the  notified  body  that  holds 

the  technical  documentation  concerning  the  EC  type >• 

examination  certificate  of  all  modifications  to  'the 

approved  equipment  or  protective  system  which  must 

receive  additional  approval  where  such  changes  may 

effect  the  conformity  with  the  essential  requirements 

or  the  prescribed  conditions  for  use  of  the  product. 

This  additional  approval  Is  given  In  the  form  of  an 

addition 

to 

the 

original 

EC 

type-examination 

cert IfIcate . 

7. 

Each  notified  body  shall  communicate  to  the  other 

notified  bodies  the  relevant  Information  concerning  the 

EC  type-examination  certificates  and  additions  Issued 

and  withdrawn. 

- 61  -

8. 

The  other  notified  bodies  may  receive  copies  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. 

9. 

The  manufacturer  or 

his-  authorized 

representative 

established 

in  the  Community 

shall  keep  with  the 

technical  documentation  copies  of  EC  type-examination 

certificates  and  their  additions  for  a  period  ending  at 

least  ten  years  after  the  last  equipment  or  protective 

systems  has  been  manufactured. 

the  manufacturer 

Where  neither 
authorized 
representative  Is  established  within  the  Community,  the 
obligation  to  keep  the  technical  documentation  avallabe 
shall  be  the  responsibility  of  the  person  who  places 
the  product  on  the  Community  market. 

nor  his 

-  62  -

ANNEX  IV 

Module:  Production  quality  assurance 

1. 

module 

describes 

p r o c e d u r e/  whereby 

This 
the 
the 
manufacturer  who  satisfies  the  obligations  of  point  2 
ensures  and  declares  that  the  products  concerned  are  In 
conformity  with  the  type  as  described  In  the  EC  type-
examination  certificate  and  satisfy  the  requirements  of 
the  Directive  that  apply  to  them.  The  manufacturer 
shall  affix  the  CE  mark  to  each  equipment 
and  draw  up 
a  written  declaration  of  conformity.  The  CE  mark  shall 
be  accompanied  by  the  Identification  symbol  of  the 
notified 
as 
specified  In  point  4. 

responsible 

monitoring 

body 

for 

EC 

2. 

The  manufacturer  shall  operate  an  approved 
system  for  production,  final  equipment 
testing  as  specified 
subject  to  monitoring  as  specified  In  point  4. 

quality 
Inspection  and 
In  paragraph  3  and  shall  be 

3. 

Quai Ity  system 

3.1  The 

manufacturer 

for 
assessment  of  his  quality  system  with  a  notified  body 
of  his  choice,  for  the  equipment 

application 

concerned. 

shall 

lodge 

an 

The  application  shall  Include: 

all  relevant  information  for  the  product  category 
envisaged; 

-  63  -

the  d o c u m e n t a t i on  concerning  the  quality  system; 

-  the  technical  d o c u m e n t a t i on  of  the  approved  type  and 

a  copy  of  the  EC  t y p e - e x a m i n a t i on  c e r t i f i c a t e. 

3.2  The  quality  system  shall  ensure  c o m p l i a n ce  of  the 

equipment 

w i t h - t he  type*  a s: described  H n  the  EC  type-^v 

e x a m i n a t i on  c e r t i f i c a te  and  with  the  r e q u i r e m e n ts  of 

the  D i r e c t i ve  that  apply  to  them. 

All  the  e l e m e n t s,  r e q u i r e m e n ts  and  p r o v i s i o ns  adopted 

by  the  m a n u f a c t u r er  sha I I be  documented  in  a  s y s t e m a t ic 

and  orderly  manner  In  the  form  of  w r i t t en  p o l i c i e s, 

p r o c e d u r es 

and 

I n s t r u c t i o n s. 

The 

quality 

system 

d o c u m e n t a t i on  must  permit  a  consistent  interpretation 

of  the  qua I 1ty  p r o g r a m m e s,  p I an,  m a n u a Is  and  r e c o r d s. 

It  shall  contain  in  particular  an  a d e q u a te  d e s c r i p t i on 

of 

-  the 

quality 

o b j e c t i v es 

and 

the 

o r g a n i z a t i o n al 

s t r u c t u r e, 

r e s p o n s i b i l i t i es 

and 

p o w e rs 

of 

the . 

management  with  regard  to  equipment 

quality-, 

the 

m a n u f a c t u r i n g, 

quality 

control 

and 

quality 

a s s u r a n ce 

t e c h n i q u e s, 

p r o c e s s es 

and 

s y s t e m a t ic 

a c t i o ns  that  will  be  used; 

the  e x a m i n a t i o ns  and  tests  that  will  be  carried  out 

b e f o r e, 

during 

and 

after 

m a n u f a c t u r e, 

and 

the 

frequency  with  which  they  will  be  carried  out; 

the  quality  r e c o r d s,  such  as  inspection  reports  and 

test  data,  c a l i b r a t i on  data,  q u a l i f i c a t i on  reports 

of  the  personnel  c o n c e r n e d,  etc.-, 

the  m e a ns  to  monitor  the  achievement  of  the  required 

equipment 

quality  and  the  e f f e c t i ve  o p e r a t i on  of 

the  qua I Ity  system. 

-  64  -

3.3  The  n o t i f i ed  body  shall  a s s e ss  the  q u a l i ty  s y s t em  to 

d e t e r m i ne 

w h e t h er 

It 

s a t i s f i es 

the 

r e q u i r e m e n ts 

r e f e r r ed  to  in  point  3 . 2.  It  shall  p r e s u me  c o n f o r m i ty 

with  t h e se  r e q u i r e m e n ts  in  respect  of  q u a l i ty  s y s t e ms 

that  Implement  the  relevant  h a r m o n i z ed  s t a n d a r d. 

The  a u d i t i ng  team  shall  have  at  least  o ne  m e m b er  with 

e x p e r i e n ce  of  e v a l u a t i on  in  the  e q u i p m e nt 

t e c h n o l o gy 

c o n c e r n e d.  The  e v a l u a t i on  p r o c e d u re  shall 

Include  an 

i n s p e c t i on  visit  to  the  m a n u f a c t u r e r 's  p r e m i s e s. 

The  d e c i s i on  shall  be  n o t i f i ed  to  the  m a n u f a c t u r e r.  The 

n o t i f i c a t i on 

shall 

c o n t a in 

the 

c o n c l u s i o ns 

of 

the 

e x a m i n a t i on  and  the  r e a s o n ed  a s s e s s m e nt  d e c i s i o n. 

3.4  The 

m a n u f a c t u r er 

shall 

u n d e r t a ke 

to 

fulfil 

the 

o b l i g a t i o ns 

a r i s i ng 

out 

of 

the 

q u a l i ty 

s y s t em 

as 

a p p r o v ed  and  to  u p h o ld  It  so  that  it  r e m a i ns  a d e q u a te 

and  e f f Ic I e n t. 

The  m a n u f a c t u r er  or  his  author I zed  r e p r é s e n t ât Ive  shaI I 

keep  the  n o t i f i ed  body  that  has  a p p r o v ed  the  q u a l i ty 

s y s t em  Informed  of  any  Intended  u p d a t i ng  of  the  q u a l i ty 

s y s t e m. 

The  n o t i f i ed  body  shall 

e v a l u a te 

the  m o d i f i c a t i o ns 

p r o p o s ed  and  d e c i de  w h e t h er  the  a m e n d ed  q u a l i ty  system 

will  still  s a t i s fy  the  r e q u i r e m e n ts  r e f e r r ed 

to  in 

p a r a g r a ph  3.2  or  w h e t h e r .a  r e - a s s e s s m e nt  Is  r e q u i r e d. 

It' shall  n o t i fy  Its  d e c i s i on  to  the  m a n u f a c t u r e r.  The 

n o t i f i c a t i on 

shall 

c o n t a in 

the 

c o n c l u s i o ns 

of 

the 

e x a m i n a t i on  and  the  r e a s o n ed  a s s e s s m e nt  d e c i s i o n. 

-  65  -

4. 

S u r v e i l l a n ce  under  the  r e s p o n s i b i l i ty  of  the  n o t i f i ed 

body 

4.1 

The  p u r p o se  of  s u r v e i l l a n ce  is  to  m a ke  s u re  that  the 

m a n u f a c t u r er  duly  fulfils  the  o b l i g a t i o ns  a r i s i ng  out 

of  the  a p p r o v ed  qua Iity  s y s t e m. 

4.2  The  m a n u f a c t u r er  shall  allow  the  n o t i f i ed  body  e n t r a n ce 

for 

inspection 

p u r p o s es 

to 

the 

l o c a t i o ns 

of 

m a n u f a c t u r e,  inspection  and  t e s t i n g,  and  s t o r a ge  and 

shall  p r o v i de  It  with  all  n e c e s s a ry 

I n f o r m a t i on 

in 

part IcuIar 

the  q u a l i ty  system  d o c u m e n t a t i on 

the  quality  r e c o r d s,  such  as  Inspection  r e p o r ts  and 

test  d a t a,  c a l i b r a t i on  d a t a,  q u a l i f i c a t i on  reports 

of  the  personnel  c o n c e r n e d,  e t c. 

4.3  The  n o t i f i ed  body  shall  p e r i o d i c a l ly  carry  out  a u d i ts 

to  m a ke 

sure 

that 

the  m a n u f a c t u r er 

m a i n t a i ns 

and 

a p p l i es  the  quality  system  and  shall  p r o v i de  an  audit 

report  to  the  m a n u f a c t u r e r. 

4.4  A d d i t i o n a l ly 

the  n o t i f i ed 

body  may 

pay 

u n e x p e c t ed 

v i s i ts  to  the  m a n u f a c t u r e r.  During  such  v i s i ts  the 

n o t i f i ed  body  may  carry  o u t,  or  cause  to  be  carried 

o u t, 

tests 

to  verify 

that 

the  quality 

system 

is 

f u n c t i o n i ng  c o r r e c t l y,  if  n e c e s s a r y.  The  n o t i f i ed  body 

shall  p r o v i de  the  m a n u f a c t u r er  with  a  visit  report  and, 

If  a  test  has  taken  p l a c e,  with  a  test  r e p o r t. 

-  66  -

The  m a n u f a c t u r er  s h a l l,  for  a  period  ending  at  least 

ten 

years 

after 

the 

last 

equipment 

has 

been 

m a n u f a c t u r e d,  keep  at  the  disposal  of  the  national 

author 11les : 

the  d o c u m e n t a t i on  referred  to  In  the  second  Indent, 

of  point  3.1; 

the  updating  referred  to  In  the  second  p a r a g r a ph  of 

point  3.4; 

the  d e c i s i o ns  and  reports  from  the  notified  body 

which  are  referred  to  in  the  final  p a r a g r a ph  of 

point  3.4,  point  4.3  and  point  4.4. 

6. 

Each  notified  body  shall  give  the  other  notified  bodies 

the  relevant  Information  c o n c e r n i ng  the  quality  system 

a p p r o v a ls  issued  and  w i t h d r a w n. 

-  67  -

ANNEX  V 

M o d u l e:  P r o d u ct  v e r i f i c a t i on 

T h is 

m o d u le 

d e s c r i b es 

the 

p r o c e d u re 

w h e r e by 

a 

m a n u f a c t u r er 

or 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve 

e s t a b l i s h ed  w i t h in  the  C o m m u n i ty  c h e c ks  and 

a t t e s ts 

that  the  e q u i p m e nt 

subject  to  the  p r o v i s i o ns  of  point 

3  are  In  c o n f o r m i ty  with  the  type  as  d e s c r i b ed  in  the 

E C - t y pe 

e x a m i n a t i on 

c e r t i f i c a te 

and 

s a t i s fy 

the 

relevant  r e q u i r e m e n ts  of  the  D i r e c t i v e. 

The  m a n u f a c t u r er  shall  take  all  m e a s u r es  n e c e s s a ry  in 

order  that  the  m a n u f a c t u r i ng  p r o c e ss  e n s u r es  c o n f o r m i ty 

of  the  e q u i p m e nt 

with  the  type  as  d e s c r i b ed  In  the  EC 

t y p e - e x a m i n a t i on  c e r t i f i c a te  and  with  the  r e q u i r e m e n ts 

of  the  D i r e c t i ve  that  apply  to  them.  He  shall  affix  the 

C E - m a rk 

to 

each 

e q u i p m e nt 

and 

shall 

d r aw 

up 

a 

d e c l a r a t i on  of  c o n f o r m i t y. 

The  n o t i f i ed 

body  shall 

carry  out 

the 

a p p r o p r i a te 

e x a m i n a t i o ns  and  tests  In  order  to  check  the  c o n f o r m i ty 

of  the  e q u i p m e nt 

with  the  relevant  r e q u i r e m e n ts  of  the 

D i r e c t i ve  either  by  e x a m i n a t i on  and  testing  of  e v e ry 

product  as  s p e c i f i ed  In  point  4  or  by  e x a m i n a t i on  and 

testing 

of 

e q u i p m e nt 

on 

a 

s t a t i s t i c al 

b a s i s, 

as 

s p e c i f i ed 

in 

point 

5, 

at 

the 

c h o i ce 

of 

the 

m a n u f a c t u r e r. 

The  m a n u f a c t u r er  or  h I s  author I zed  r e p r e s e n t a t i ve  shall 

keep  a  copy  of  the  d e c l a r a t i on  of  c o n f o r m i ty  for  a 

p e r i od 

e n d i ng 

at 

least 

ten 

y e a rs 

after 

the 

last 

e q u i p m e nt  has  been  m a n u f a c t u r e d. 

-  68  -

4. 

V e r i f i c a t i on 

by 

e x a m i n a t i on 

and 

testing 

of 

every 

equIpment 

4.1 

All 

equipment 

shall 

be 

individually 

e x a m i n ed 

and 

a p p r o p r i a te 

tests 

as 

set 

out 

In 

the 

relevant 

s t a n d a r d ( s)  referred  to  In  A r t i c le  5  or  e q u i v a l e n t* 

tests  shall  be  carried  out  In  order  to  verify  their' 

conformity  with  the  type  as  described  In  the  EC-type 

e x a m i n a t i on  c e r t i f i c a te  and  the  relevant  r e q u i r e m e n ts 

of 

the  D i rect I ve . 

4.2  The  notified  body  shall  affix  or  cause  to  be  affixed, 

Its  Identification  symbol  to  each  approved  equipment 

and 

draw 

up 

a  w r i t t en 

c e r t i f i c a te 

of 

c o n f o r m i ty 

relating  to  the  tests  carried  o u t. 

4.3  The  m a n u f a c t u r er  or  his  authorized  r e p r e s e n t a t i ve  shall 

ensure  that  he  is  able  to  supply  the  notified  body's 

c e r t i f i c a t es  of  c o n f o r m i ty  on  request.. 

5. 

Statistical  v e r i f i c a t i on 

5.1 

The  m a n u f a c t u r er  shall  present  his  equipment 

In  the 

form  of  h o m o g e n e o us  lots  and  shall  take  all  m e a s u r es 

necessary  tin  order 

that 

the  m a n u f a c t u r i ng 

process 

ensures  the  homogeneity  of  each  lot  p r o d u c e d. 

5.2  All  equipment 

shall  be  available  for  v e r i f i c a t i on  in 

the  form  of  h o m o g e n e o us  lots.  A  random  sample  shall  be 
from  each  lot.  P r o d u c ts  in  a  sample  shall  b e1 

drawn 

Individually  examined  and  a p p r o p r i a te  tests  as  set  out 

In  the  relevant  s t a n d a r d ( s)  referred  to  In  A r t i c le  5, 

or  equivalent  t e s t s,  shall  be  carried  out  to  ensure 

their  conformity  with  the  relevant  r e q u i r e m e n ts  of  the 

Directive 

and  to  determine  whether  the  lot  Is  accepted 

or  r e j e c t e d. 

-  69  -

5.3  A 

sampling 

plan 

with 

the 

following 

o p e r a t i ng 

c h a r a c t e r i s t i cs  Is  applied: 

a  standard  quality  level  c o r r e s p o n d i ng  to  a  95  % 

p r o b a b i l i ty  of  a c c e p t a n ce  with  a  p e r c e n t a ge  of  non 

c o n f o r m i ty  between  0,5  and  1,5  %, 

a l i m it  quality  correspond ing  to  a  5  %  probabI I Ity, 

of  a c c e p t a n ce  with  a  p e r c e n t a ge  of  n o n - c o n f o r m i ty 

• between  5  and  10  %. 

5.4 

In  the  case  of  accepted  lots,  the  notified  body  shall 

a f f i x,  or  cause  to  be  affixed, 

Its 

I d e n t i f i c a t i on 

symbol  to  each  equipment  and  shall  draw  up  a  w r i t t en 

c e r t i f i c a te  of  conformity  relating  to  the  tests  carried 

o u t.  All  equipment 

in  the  lot  may  be  put  on  the  market 

except  those  p r o d u c ts  from  the  sample  which  were  found 

not  to  be  In  c o n f o r m i t y. 

If  a 

lot 

is  rejected, 

the  notified 

body  or 

the 

competent  author Ity  shaI I  take  a p p r o p r i a te  m e a s u r es  to 

prevent  the  putting  on  the  market  of  that  lot.  In  the 

event  of  frequent  rejection  of  lots  the  not I fled  body 

may  suspend  the  statistical  v e r i f i c a t i o n. 

The  m a n u f a c t u r er  may,  under  the  r e s p o n s i b i l i ty  of  the 

notified  body,  affix  the  latter's  identification  symbol 

during  the  m a n u f a c t u r i ng  p r o c e s s. 

5.5  The  m a n u f a c t u r er 

or 

his 

authorized 

r e p r e s e n t a t i ve 

shall  e n s u re  that  he  is  able  to  supply  the  notified 

body's  cert I fIcates  of  conformity  on  r e q u e s t. 

-  70  -

ANNEX  VI 

M o d u l e:  C o n f o r m i ty  to  type 

T h is  m o d u le 

d e s c r i b es 

that 

part 

of 

the 

p r o c e d u re 

w h e r e by 

the 

m a n u f a c t u r er 

or 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve  e s t a b l i s h ed  w i t h in  the  C o m m u n i ty  e n s u r es 

and  d e c l a r es  that  the  e q u i p m e nt  and  p r o t e c t i ve  s y s t e ms 

are  In  c o n f o r m i ty  with  the  type  as  d e s c r i b ed  in  the  EC 

t y p e - e x a m i n a t i on  c e r t i f i c a te  and  satisfy  the  relevant 

r e q u i r e m e n ts  of  the  D i r e c t i v e.  The  m a n u f a c t u r er  shall 

affix  the  CE  mark  to  each  e q u i p m e nt  and  p r o t e c t i ve 

system  and  draw  up  a  w r i t t en  d e c l a r a t i on  of  c o n f o r m i t y. 

The  m a n u f a c t u r er  shall  take  all  m e a s u r es  n e c e s s a ry  to 

e n s u re 

that 

the 

m a n u f a c t u r i ng 

p r o c e ss 

a s s u r es 

c o m p l i a n ce  of  the  m a n u f a c t u r ed  e q u i p m e nt  and  p r o t e c t i ve 

s y s t e ms  with  the  type  as  d e s c r i b ed  in  the  EC  t y p e-

e x a m i n a t i on 

c e r t i f i c a te 

and 

with 

the 

relevant, 

r e q u i r e m e n ts  of  the  D i r e c t i v e. 

The  m a n u f a c t u r er  or  his  a u t h o r i z ed  r e p r e s e n t a t i ve  shall 

keep  a  copy  of  the  d e c l a r a t i on  of  c o n f o r m i ty  for  a 

period 

ending 

at 

least 

ten  y e a rs 

after 

the 

last 

e q u i p m e nt  or  p r o t e c t i ve  system 

has  been  m a n u f a c t u r e r d. 

W h e re 

neither 

the  m a n u f a c t u r er 

nor 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve  is  e s t a b l i s h ed  w i t h in  the  C o m m u n i t y,  the 

o b l i g a t i on 

to 

keep 

the 

technical 

d o c u m e n t a t i on 

a v a i l a b le  shall  be  the  r e s p o n s i b i l i ty  of  the  p e r s on  who 

p l a c es 

the  equipment 

or 

p r o t e c t i ve 

system 

on 

the 

C o m m u n i ty  m a r k e t. 

L_ 

-  71  -

For  each  equipment  or  protective  system 

manufactured 

the  protection 

aspects  of  the  product  shall  be  carried 

out  by  the  manufacturer  or  on  his  behalf.  The  tests 

shall 

be  carried  out  on  the  responsibility  of  a 

notified  body,  chosen  by  the  manufacturer. 

On 

the  responsibility  of 

the  notified 

body, 

the 

manufacturer  shall  affix  the  former's  Identification 

symbol  during  the  manufacturing  process. 

-  72  -

ANNEX  VI I 

M o d u l e:  Product  quality  a s s u r a n ce 

1. 

This 

m o d u le 

d e s c r i b es 

the 

p r o c e d u re 

w h e r e by 

the 

m a n u f a c t u r er  who  s a t i s f i es  the  o b l i g a t i o ns  of  point  2 

e n s u r es  and  d e c l a r es  that  the  equipment  and  p r o t e c t i ve 

s y s t e ms  are  in  c o n f o r m i ty  with  the  type  as  d e s c r i b ed  In 

the  EC  t y p e - e x a m i n a t i on  c e r t i f i c a t e.  The  m a n u f a c t u r er 

shall  affix  the  CE  mark  to  each  product  and  draw  up  a 

w r i t t en  d e c l a r a t i on  of  c o n f o r m i t y.  The  CE  mark  shall  be 

a c c o m p a n i ed 

by 

the 

Identification 

symbol 

of 

the 

notified  body  r e s p o n s i b le  for - surveI I Ianee  as  s p e c i f i ed 

in  poInt  4. 

2. 

The  m a n u f a c t u r er 

shall  o p e r a te  an  approved 

quality 

system 

for 

final 

equipment 

and 

p r o t e c t i ve 

system 

Inspection  and  testing  as  s p e c i f i ed  tn  p a r a g r a ph  3  and 

shall  be  subject  to  surveI I Iance  as  s p e c i f i ed  in  point» 

4. 

3. 

Qua Ilty  system 

3.1.  The  m a n u f a c t u r er  shall  lodge  an  a p p l i c a t i on  for 

assessment 

of 

his 

quality 

system 

for 

the 

equipment  and  p r o t e c t i ve  s y s t e m s,  with  a  n o t i f i ed 

body  of  his  c h o i c e. 

The  a p p l i c a t i on  shall  include: 

all 

relevant 

information 

for 

the 

product 

category  e n v i s a g ed 

-  73  -

the  quality  s y s t e m 's  d o c u m e n t a t i on 

the  technical  d o c u m e n t a t i on  of  the  approved 

type  and  a  copy  of  the  EC  t y p e - e x a m an I at Ion 

cert IfIcate . 

3.2.  Under  the  quality  system,  each  e q u i p m e nt 

and-* 

p r o t e c t i ve 

system 

shall 

be 

e x a m i n ed 

and 

a p p r o p r i a te  tests  as  set  out 

in  the  relevant 

s t a n d a r d ( s) 

referred 

to 

In 

A r t i c le 

5 

or 

equivalent  tests  shall  be  carried  out  in  order  to 

e n s u re 

Its 

c o n f o r m i ty 

with 

the 

relevant 

r e q u i r e m e n ts  of  the  D i r e c t i v e.  All  the  e l e m e n t s, 

r e q u i r e m e n ts 

and 

p r o v i s i o ns 

adopted 

by 

the 

m a n u f a c t u r er  shall  be  d o c u m e n t ed  in  a  s y s t e m a t ic 

and 

orderly 

manner 

in  the  -form 

of 

w r i t t en 

p o l i c i e s, 

p r o c e d u r es 

and 

i n s t r u c t i o n s. 

This 

quality 

system 

d o c u m e n t a t i on 

shall 

e n s u re 

a 

common  u n d e r s t a n d i ng  of  the  quality  p r o g r a m m e s, 

p l a n s,  m a n u a ls  and  r e c o r d s. 

It  shall 

contain 

in  particular 

an 

a d e q u a te 

descr I pt ion  of : 

the  quality  o b j e c t i v es  and  the  o r g a n i z a t i o n al 

s t r u c t u r e,  r e s p o n s i b i l i t i es  and  p o w e rs  of  the 

management  with  regard  to  product  q u a l i t y, 

the 

e x a m i n a t i o ns 

and 

tests 

that 

will 

be 

carried  out  after  m a n u f a c t u re 

the  m e a ns  to  monitor  the  e f f e c t i ve  o p e r a t i on 

of  the  qua I Ity  system 

quality  records,-  such  as  Inspection  reports 

and  test  d a t a,  c a l i b r a t i on  d a t a,  q u a l i f i c a t i on 

reports  of  the  personnel  c o n c e r n e d,  e t c. 

-  74  -

3 . 3. 

T he  n o t i f i ed  body  shall  a s s e ss  the  q u a l i ty  s y s t em 

to 

d e t e r m i ne 

w h e t h er 

It 

s a t i s f i es 

the 

r e q u i r e m e n ts  r e f e r r ed  to  in  p o i nt  3 . 2.  It  shall 

p r e s u me 

c o n f o r m i ty 

w i th 

t h e se 

r e q u i r e m e n ts 

In 

r e s p e ct  of  q u a l i ty  s y s t e ms  that 

I m p l e m e nt 

the 

r e l e v a nt  h a r m o n i z ed  s t a n d a r d. 

T he  a u d i t i ng  team  shall  have  at  least  o ne  m e m b er 

e x p e r i e n c ed 

as 

an 

a s s e s s or 

In 

the 

p r o d u ct 

t e c h n o l o gy 

c o n c e r n e d.  T he  a s s e s s m e nt 

p r o c e d u re 

shall 

i n c l u de 

an 

a s s e s s m e nt 

v i s it 

to 

the 

m a n u f a c t u r e r 's  p r e m i s e s. 

T he 

d e c i s i on 

shall 

be 

n o t i f i ed 

to 

the 

m a n u f a c t u r e r.  T he  not I f I cat Ion  sha I I* c o n t a in  the 

c o n c l u s i o ns  of  the  e x a m i n a t i on  and  the  r e a s o n ed 

a s s e s s m e nt  d e c i s i o n. 

3 . 4. 

The  m a n u f a c t u r er  shall  u n d e r t a ke  to  d i s c h a r ge  the 

o b l i g a t i o ns  a r i s i ng  from  the  q u a l i ty  s y s t em  as 

a p p r o v ed  and  to  m a i n t a in  it  In  an  a p p r o p r i a te  and 

eff I c i ent  m a n n e r. 

The  m a n u f a c t u r er  or  his  a u t h o r i z ed  r e p r e s e n t a t i ve 

shall*  k e ep  the  n o t i f i ed  body  w h i ch  h as  a p p r o v ed 

the 

q u a l i ty 

s y s t em 

Informed 

of 

any 

Intended 

u p d a t i ng  of  the  q u a l i ty  s y s t e m. 

The 

n o t i f i ed 

body 

shall 

e v a l u a te 

the 

m o d i f i c a t i o ns  p r o p o s ed 

and 

d e c i de 

w h e t h er 

the 

m o d i f i ed  q u a l i ty  s y s t em  will  still  s a t i s fy 

the 

r e q u i r e m e n ts 

r e f e r r ed 

to  in  p a r a g r a ph 

3 . 2.  or 

w h e t h er  a  r e - a s s e s s m e nt  Is  r e q u i r e d. 

-  75  -

It  shall  n o t i fy  its  d e c i s i on  to  the  m a n u f a c t u r e r. 

The  n o t i f i c a t i on  shall  c o n t a in  the  c o n c l u s i o ns  of 

the 

e x a m i n a t i on 

and 

the 

r e a s o n ed 

a s s e s s m e nt 

dec I s Ion. 

4. 

S u r v e 11 I ance  under  the  r e s p o ns I b 1 I Ity  of  the  n o t i f i ed 

body 

4 . 1. 

The  p u r p o se  of  s u r v e i l l a n ce  is  to  m a ke  sure  that 

the  m a n u f a c t u r er 

duly  f u l f i ls  the 

o b l i g a t i o ns 

a r i s i ng  out  of  the  a p p r o v ed  q u a l i ty  s y s t e m. 

4 . 2. 

The  m a n u f a c t u r er  shall  a l l ow  the  n o t i f i ed  body 

e n t r a n ce  for  inspection  p u r p o s es  to  the  l o c a t i o ns 

of 

i n s p e c t i o n,  testing,  and  s t o r a ge  and 

shall 

p r o v i de 

it  with  all  n e c e s s a ry 

I n f o r m a t i o n,  In 

par tIcuIar 

the  q u a l i ty  system  d o c u m e n t a t i on 

the  technical  d o c u m e n t a t i on 

the 

q u a l i ty 

r e c o r d s, 

such 

as 

i n s p e c t i on 

r e p o r ts 

and 

test 

d a t a, 

c a l i b r a t i on 

d a t a, 

q u a l i f i c a t i on 

r e p o r ts 

of 

the 

p e r s o n n el 

c o n c e r n e d,  e t c. 

4 . 3. 

The  n o t i f i ed  body  shall  p e r i o d i c a l ly  c a r ry  out 

a u d i ts  to  e n s u re  that  the  m a n u f a c t u r er  m a i n t a i ns 

and  a p p l i es  the  q u a l i ty  system  and  shall  p r o v i de 

an  audit  report  to  the  m a n u f a c t u r e r. 

-  76  -

4 . 4.  A d d i t i o n a l l y, 

the 

n o t i f i ed 

b o dy 

m ay 

pay 

u n e x p e c t ed  v i s i ts  to  the  m a n u f a c t u r e r.  At 

the 

time  of  such  v i s i t s,  the  n o t i f i ed  b o dy  m ay  c a r ry 

out  t e s ts  or  h a ve  them  c a r r i ed  out  In  o r d er  to 

c h e ck 

the 

p r o p er 

f u n c t i o n i ng 

of 

the 

q u a l i ty 

s y s t em  w h e re  n e c e s s a r y; 

It  shall 

p r o v i de  tthe 

m a n u f a c t u r er  w i th  a  visit  report  a n d,  if  a  test 

has  b e en  c a r r i ed  o u t,  w i th  a  test  r e p o r t. 

T he  m a n u f a c t u r er  s h a l l,  for  a  p e r i od  e n d i ng  at  least 

ten  y e a rs  after  the  last  e q u i p m e nt  or  p r o t e c t i ve  s y s t em 

has  b e en  m a n u f a c t u r e d,  k e ep  at  the  d i s p o s al  of  the 

n a t i o n al  a u t h o r i t i e s: 

the  d o c u m e n t a t i on  r e f e r r ed  to  in  the  t h i rd  Indent  of 

po I nt  3 . 1; 

the  u p d a t i ng  r e f e r r ed  to  In  the  s e c o nd  p a r a g r a ph  of 

point  3 . 4; 

the  d e c i s i o ns  and  r e p o r ts  from  the  n o t i f i ed 

b o dy 

w h i ch  are  r e f e r r ed  to  in  the  final  p a r a g r a ph  of 

point  3 . 4,  point  4.3  and  point  4 . 4. 

Each  n o t i f i ed  body  shall  f o r w a rd  to  the  o t h er  n o t i f i ed 

b o d i es  the  r e l e v a nt  i n f o r m a t i on  c o n c e r n i ng  the  q u a l i ty 

s y s t em  a p p r o v a ls  Issued  and  w i t h d r a w n. 

-  77  -

A N N EX  VI I I 

M o d u l e:  Internal  control  of  p r o d u c t i on 

1. 

T h is 

m o d u le 

d e s c r i b es 

the 

p r o c e d u re 

w h e r e by 

the 

m a n u f a c t u r er 

or 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve 

e s t a b l i s h ed  w i t h in  the  C o m m u n i t y,  who  c a r r i es  out  the 

o b l i g a t i o ns  laid  down  in  point  2,  e n s u r es  and  d e c l a r es 

that  the  e q u i p m e nt  s a t i s fy  the  relevant  r e q u i r e m e n ts  of 

the  D i r e c t i v e.  The  m a n u f a c t u r er  shall  affix  the  CE  mark 

to  each  e q u i p m e nt 

and  draw  up  a  w r i t t en  d e c l a r a t i on  of 

c o n f o rm Ity. 

2. 

The 

m a n u f a c t u r er 

shall 

e s t a b l i sh 

the 

technical 

d o c u m e n t a t i on  d e s c r i b ed  In  p a r a g r a ph  3  and  he  or  his 

a u t h o r i z ed 

r e p r e s e n t a t i ve 

e s t a b l i s h ed 

with 

the 

C o m m u n i ty  shall  keep  it  for  a  period  ending  at  least  10 

y e a rs  after  the  last  e q u i p m e nt 

has  been  m a n u f a c t u r ed 

at  the  disposal  of  the  relevant  national 

a u t h o r i t i es 

for  inspection  p u r p o s e s. 

W h e re 

neither 

the  m a n u f a c t u r er 

nor 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve  Is  e s t a b l i s h ed  w i t h in  the  C o m m u n i t y,  the 

o b l i g a t i on 

to 

keep 

the 

technical 

d o c u m e n t a t i on 

a v a i l a b le  shall  be  the  r e s p o n s i b i l i ty  of  the  p e r s on  who 

p l a c es  the  e q u i p m e nt  on  the  C o m m u n i ty  m a r k e t. 

3. 

T e c h n i c al  d o c u m e n t a t i on  shall  e n a b le  the  c o n f o r m i ty  of 

the  e q u i p m e nt 

with  the  relevant  r e q u i r e m e n ts  of  the 

D i r e c t i ve  to  be  a s s e s s e d.  It  s h a l l,  as  far  as  relevant 

for  such  a s s e s s m e n t,  cover  the  d e s i g n,  m a n u f a c t u re  and 

o p e r a t i on  of  the  p r o d u c t. 

The  m a n u f a c t u r er  or  his  a u t h o r i z ed  r e p r e s e n t a t i ve  shall 

keep  a  copy  of  the  d e c l a r a t i on  of  c o n f o r m i ty  with  the 

technical  d o c u m e n t a t i o n; 

-  78  -

5. 

The  m a n u f a c t u r er  shall  take  all  m e a s u r es  n e c e s s a ry  in 

order 

that 

the  m a n u f a c t u r i ng 

p r o c e ss 

shall 

e n s u re 

c o m p l i a n ce 

of 

the  m a n u f a c t u r ed 

equipment 

with 

the 

technical  d o c u m e n t a t i on  referred  to  In  point  2  and  with 

the  relevant  r e q u i r e m e n ts  of  the  D i r e c t i v e. 

-  79  -

A N N EX  IX 

M o d u l e:  full  q u a l i ty  a s s u r a n ce 

1. 

T h is 

m o d u le 

d e s c r i b es 

the 

p r o c e d u re 

w h e r e by 

the 

m a n u f a c t u r er  who  s a t i s f i es  the  o b l i g a t i o ns  of  p a r a g r a ph 

2  e n s u r es  and  d e c l a r es  that  the  e q u i p m e nt 

c o n c e r n ed 

s a t i s fy  the  relevant  r e q u i r e m e n ts  of  the  d i r e c t i v e.  The 

m a n u f a c t u r er  shall  affix  the  CE  mark  to  each  e q u i p m e nt 

and  d r aw  up  a  w r i t t en  d e c l a r a t i on  of  c o n f o r m i t y.  The  CE 

m a rk  shall  be  a c c o m p a n i ed  by  the  i d e n t i f i c a t i on  symbol 

of 

the 

n o t i f i ed 

body 

r e s p o n s i b le 

for 

the 

EC 

s u r ve i I Iance . 

2. 

T he  m a n u f a c t u r er 

shall 

o p e r a te 

an  a p p r o v ed 

q u a l i ty 

s y s t em 

for  d e s i g n,  m a n u f a c t u re 

and 

final 

e q u i p m e nt 

i n s p e c t i on  and  testing  as  s p e c i f i ed  in  p a r a g r a ph  3  and 

shall  be  s u b j e ct  to  EC  s u r v e i l l a n ce  as  s p e c i f i ed  In 

p a r a g r a ph  4. 

3. 

Qua I Ity  s y s t em 

3.1 

T he 

m a n u f a c t u r er 

shall 

lodge 

an 

a p p l i c a t i on 

for 

a s s e s s m e nt  of  his  q u a l i ty  s y s t em  with  a  n o t i f i ed  b o d y. 

The  a p p l i c a t i on  shall  i n c l u d e: 

all  r e l e v a nt  i n f o r m a t i on  for  the  e q u i p m e nt 

c a t e g o ry 

env I saged 

the  q u a l i ty  s y s t e m 's  d o c u m e n t a t i on 

3.2 

T he  q u a l i ty 

s y s t em 

shall 

e n s u re 

c o m p l i a n ce 

of 

the 

e q u i p m e nt 

with 

the 

relevant 

r e q u i r e m e n ts 

of 

the 

d i rect i ve . 

-  80  -

All  the  e l e m e n t s,  r e q u i r e m e n ts  and  p r o v i s i o ns  a d o p t ed 

by  the  m a n u f a c t u r er  shall  be  d o c u m e n t ed  In  a  s y s t e m a t ic 

and  o r d e r ly  m a n n er  In  the  form  of  w r i t t en  p o l i c i e s, 

p r o c e d u r es 

and 

I n s t r u c t i o n s. 

T h is 

q u a l i ty 

s y s t em 

d o c u m e n t a t i on  shall  e n s u re  a  c o m m on  u n d e r s t a n d i ng  of 

the  q u a l i ty  p o l i c i es  and  p r o c e d u r es  such  as  q u a l i ty 

p r o g r a m m e s,  p l a n s,  m a n u a ls  and  r e c o r d s. 

It  shall  c o n t a in  in  p a r t i c u l ar  an  a d e q u a te  d e s c r i p t i on 

of 

the 

q u a l i ty 

o b j e c t i v es 

and 

the 

o r g a n i z a t i o n al 

s t r u c t u r e, 

r e s p o n s i b i l i t i es 

and 

p o w e rs 

of 

the 

m a n a g e m e nt 

w i th 

regard 

to  d e s i gn 

and 

e q u i p m e nt 

qua I Ity, 

the 

technical 

d e s i gn 

s p e c i f i c a t i o n s, 

I n c l u d i ng 

s t a n d a r d s, 

that  will 

be  a p p l i ed 

a n d,  w h e re 

the 

s t a n d a r ds  r e f e r r ed 

to  In  a r t i c le  5  will 

not 

be 

a p p l i ed 

In  f u l l,  the  m e a ns  that  will  be  u s ed  to 

e n s u re 

that 

the 

e s s e n t i al 

r e q u i r e m e n ts 

of 

the 

d i r e c t i ve  that  apply  to  the  e q u i p m e nt  will  be  m e t, 

the 

d e s i gn 

control 

and 

d e s i gn 

v e r i f i c a t i on 

t e c h n i q u e s,  p r o c e s s es  and  s y s t e m a t ic  a c t i o ns  that 

will  be  used  w h en  d e s i g n i ng  the  e q u i p m e n t, 

the  c o r r e s p o n d i ng  m a n u f a c t u r i n g,  q u a l i ty  c o n t r ol  and 

q u a l i ty 

a s s u r a n ce 

t e c h n i q u e s, 

p r o c e s s es 

and 

s y s t e m a t ic  a c t i o ns  that  will  be  u s e d, 

the  e x a m i n a t i o ns  and  tests  that  will  be  c a r r i ed  out 

b e f o r e, 

d u r i n g, 

and 

after 

m a n u f a c t u r e, 

and 

the 

f r e q u e n cy  with  w h i ch  they  will  be  c a r r i ed  o u t, 

-  81  -

the  q u a l i ty  r e c o r d s,  such  as  I n s p e c t i on  r e p o r ts  and 

test  d a t a,  c a l i b r a t i on  d a t a,  q u a l i f i c a t i on  r e p o r ts 

of  the  p e r s o n n el  c o n c e r n e d,  e t c ., 

the  m e a ns  to  m o n i t or  the  a c h i e v e m e nt  of  the  r e q u i r ed 

d e s i gn 

and 

e q u i p m e nt 

q u a l i ty 

and 

the 

e f f e c t i ve 

o p e r a t i on  of  the  q u a l i ty  s y s t e m. 

3 . 3.  T he  n o t i f i ed  body  shall  a s s e ss  the  q u a l i ty  s y s t em  to 

d e t e r m i ne 

w h e t h er 

it 

s a t i s f i es 

the 

r e q u i r e m e n ts 

r e f e r r ed 

to 

In 

p a r a g r a ph 

3 . 2. 

It 

shall 

p r e s u me 

c o m p l i a n ce 

w i th 

t h e se 

r e q u i r e m e n ts 

in 

r e s p e ct 

of 

q u a l i ty  s y s t e ms  that  implement  the  r e l e v a nt  h a r m o n i z ed 

s t a n d a r d. 

T he 

a u d i t i ng 

team 

shall 

h a ve 

at 

least 

o ne 

m e m b er 

e x p e r i e n c ed  as  an  a s s e s s or 

In  the  p r o d u ct 

t e c h n o l o gy 

c o n c e r n e d.  The  e v a l u a t i on  p r o c e d u re  shall 

I n c l u de  an 

a s s e s s m e nt  visit  to  the  m a n u f a c t u r e r 's  p r e m i s e s. 

T he  d e c i s i on  shall  be  n o t i f i ed  to  the  m a n u f a c t u r er .  T he 

n o t i f i c a t i on 

shall 

c o n t a in 

the 

c o n c l u s i o ns 

of 

thfe 

e x a m i n a t i on  and  the  r e a s o n ed  a s s e s s m e nt  d e c i s i o n. 

• 

3 . 4.  T he 

m a n u f a c t u r er 

shall 

u n d e r t a ke 

to 

fulfil 

the 

o b l i g a t i o ns 

a r i s i ng 

out 

of 

the 

q u a l i ty 

s y s t em 

as 

a p p r o v ed  and  to  u p h o ld  It  so  that  it  r e m a i ns  a d e q u a te 

and  eff i c I e n t. 

T he 

m a n u f a c t u r er 

or 

his 

a u t h o r i z ed 

r e p r e s e n t a t i ve 

e s t a b l i s h ed 

In  the  C o m m u n i ty  shall  k e ep  the  n o t i f i ed 

body  that  has  a p p r o v ed  the  q u a l i ty  s y s t em  I n f o r m ed  of 

any  i n t e n d ed  u p d a t i ng  of  the  q u a l i ty  s y s t e m. 

T he 

n o t i f i ed 

body 

shall 

e v a l u a te 

the 

m o d i f i c a t i o ns 

p r o p o s ed  and  d e c i de  w h e t h er  the  a m e n d ed  q u a l i ty  s y s t em 

will 

still 

s a t i s fy 

the  r e q u i r e m e n ts 

r e f e r r ed 

to 

In 

p a r a g r a ph  3 . 2.  or  w h e t h er  a  r e - a s s e s s m e nt  Is  r e q u i r e d. 

-  82  -

It  shall  n o t i fy  Its  d e c i s i on  to  the  m a n u f a c t u r e r.  The 

n o t i f i c a t i on 

shall 

c o n t a in 

the 

c o n c l u s i o ns 

of 

the 

e x a m i n a t i on  and  the  r e a s o n ed  a s s e s s m e nt  d e c i s i o n. 

EC  s u r v eI I Iance 

4.1.  The  p u r p o se  of  EC  s u r v e i l l a n ce  is  to  m a ke  s u re  that  the 

m a n u f a c t u r er  duly  f u l f i ls  the  o b l i g a t i o ns  a r i s i ng  out 

of  the  a p p r o v ed  q u a l i ty  s y s t e m. 

4 . 2.  The  m a n u f a c t u r er  shall  a l l ow  the  n o t i f i ed  body  e n t r a n ce 

for  I n s p e c t i on  p u r p o s es  to  the  l o c a t i o ns  of 

d e s i g n, 

m a n u f a c t u r e,  i n s p e c t i on  and  t e s t i n g,  and  s t o r a g e,  and 

shall  p r o v i de 

it  w i th  all  n e c e s s a ry 

i n f o r m a t i o n,  in 

par t I c u I ar 

the  q u a l i ty  s y s t em  d o c u m e n t a t i on 

the  q u a l i ty  r e c o r ds  as  f o r e s e en  by  the  d e s i gn  part 

of  the  q u a l i ty  s y s t e m,  such  as  r e s u l ts  of  a n a l y s e s, 

c a l c u l a t i o n s,  t e s t s,  e t c. 

the  q u a l i ty  r e c o r ds  as  f o r e s e en  by  the  m a n u f a c t u r i ng 

part 

of 

the  q u a l i ty 

s y s t e m, 

such 

as 

i n s p e c t i on 

r e p o r ts 

and 

test 

d a t a, 

c a l i b r a t i on 

d a t a, 

q u a l i f i c a t i on  r e p o r ts  of  the  p e r s o n n el 

c o n c e r n e d, 

e t c. 

4 . 3.  The  n o t i f i ed  body  shall  p e r i o d i c a l ly 

c a r ry  out  a u d i ts 

to  m a ke 

sure 

that 

the 

m a n u f a c t u r er 

m a i n t a i ns 

and 

a p p l i es  the  q u a l i ty  s y s t em  and  shall  p r o v i de  an  audit 

report  to  the  m a n u f a c t u r e r. 

4 . 4.  A d d i t i o n a l ly 

the 

n o t i f i ed 

body 

may 

pay 

u n e x p e c t ed 

v i s i ts  to  the  m a n u f a c t u r e r.  D u r i ng  such  v i s i ts  full  or 

r e d u c ed  a u d i ts  may  be  c a r r i ed  out  by  the  n o t i f i ed  b o d y. 

The  n o t i f i ed  body  shall  p r o v i de  a  visit  r e p o rt  a n d,  if 

a p p l i c a b l e,  an  audit  report  to  the  m a n u f a c t u r e r. 

-  83 

5. 

T he  m a n u f a c t u r er  s h a l l,  for  a  p e r i od  e n d i ng  at  least  10 

y e a rs 

a f t er 

the 

last 

e q u i p m e nt 

h as 

b e en 

m a n u f a c t u r e r e d,  k e ep  at  the  d i s p o s a»  of  the  n a t i o n al 

a u t h or 111 es : 

- 

the  d o c u m e n t a t i o ns  r e f e r r ed  to  in  the  s e c o nd  indent 

of  the  s e c o nd  s u b p a r a g r a ph  of  point  3.1 

the  u p d a t I ng  refer red  to  in  the  s e c o nd  s u b p a r a g r a ph 

of  p o I nt  3.4 

the  d e c i s i o ns  and  r e p o r ts  from  the  n o t i f i ed 

body 

w h i ch  are  r e f e r r ed  to  in  the  final  s u b p a r a g r a ph  of 

p o i nt  3 . 4,  p o i n ts  4.3  and  4.4 

6. 

Each 

n o t i f i ed 

body 

shall 

p u b l i sh 

p e r i o d i c a l ly 

the 

r e l e v a nt 

I n f o r m a t i on 

c o n c e r n i ng 

the 

q u a l i ty 

s y s t em 

a p p r o v a ls  issued  and  w i t h d r a w n. 

7. 

P es Ign  e x am I natI on 

a) 

T he 

m a n u f a c t u r er 

shall 

lodge 

an 

a p p l i c a t i on 

for 

e x a m i n a t i on  of  the  d e s i gn  w i th  a  s i n g le  n o t i f i ed  b o d y^ 

b) 

T he 

a p p l i c a t i on 

sha II  e n a b le 

u n d e r s t a n d i ng 

of 

the 

d e s i g n,  m a n u f a c t u re  and  o p e r a t i on  of  the  p r o d u c t,  and 

shall  e n a b le  a s s e s s m e nt  of  c o n f o r m i ty  w i th  the  r e l e v a nt 

r e q u i r e m e n ts  of  the  d i r e c t i v e. 

11  sha I I  I nc I u de 

the 

t e c h n i c al 

d e s i gn 

s p e c i f i c a t i o n s, 

i n c l u d i ng 

s t a n d a r d s,  that  h a ve  b e en  a p p l i e d, 

the 

n e c e s s a ry 

s u p p o r t i ng 

e v i d e n ce 

for 

their 

a d e q u a c y,  in  p a r t i c u l ar  w h e re  the  s t a n d a r ds  r e f e r r ed 

to  In  a r t i c le  5  h a ve  not  b e en  a p p l i ed  In  f u l l.  T h is 

s u p p o r t i ng 

e v i d e n ce  shall 

Include  the  r e s u l ts  of 

t e s ts  c a r r i ed  out  by  the  a p p r o p r i a te  l a b o r a t o ry  of 

the  m a n u f a c t u r er  or  on  his  b e h a l f. 

84  -

c) 

The  n o t i f i ed  body  shall  e x a m i ne  the  a p p l i c a t i on  and 

w h e re  the  d e s i gn  m e e ts  the  p r o v i s i o ns  of  the  d i r e c t i ve 

that  a p p ly  to  It  shall  issue  an 

EC  d e s i gn  e x a m i n a t i on 

c e r t i f i c a te  to  the  a p p l i c a n t.  T he  c e r t i f i c a te 

shall 

c o n t a in  the  c o n c l u s i o ns  of  the  e x a m i n a t i o n,  c o n d i t i o ns 

for  Its  val Idlty.,  the  n e c e s s a ry  d a ta  for  I d e n t i f i c a t i o n. 

of  the  a p p r o v ed  d e s i gn  a n d,  if  r e l e v a n t,  a  d e s c r i p t i on 

of  the  e q u i p m e n t 's  f u n c t i o n i n g. 

d) 

T he  a p p l i c a nt  shall  k e ep  the  n o t i f i ed  b o dy  that  has 

issued  the  EC  d e s i gn  e x a m i n a t i on  c e r t i f i c a te 

i n f o r m ed 

of  any  m o d i f i c a t i on  to  the  a p p r o v ed  d e s i g n. 

M o d i f i c a t i o ns 

to 

the 

a p p r o v ed 

d e s i gn 

must 

r e c e i ve 

a d d i t i o n al  a p p r o v al  from  the  n o t i f i ed  body  that  issued 

the 

EC 

d e s i gn 

e x a m i n a t i on 

c e r t i f i c a te 

w h e re 

such 

c h a n g es  may  affect  the  c o n f o r m i ty  w i th  the  e s s e n t i al 

r e q u i r e m e n ts 

of 

the 

d i r e c t i ve 

or 

the 

p r e s c r i b ed 

c o n d i t i o ns  for  use  of  the  e q u i p m e n t.  T h is  a d d i t i o n al 

a p p r o v al 

is  g i v en  In  the  form  of  an  a d d i t i on  to  the 

o r i g i n al  EC  d e s i gn  e x a m i n a t i on  c e r t i f i c a t e. 

; 

e) 

T he  not if led  b o d i es  shall 

p u b l i sh 

p e r i o d i c a l ly 

the 

r e l e v a nt  I n f o r m a t i on  c o n c e r n i ng 

the  a p p l i c a t i o ns  for  EC  d e s i gn  e x a m i n a t i on  r e c e i v ed 

the  EC  d e s i gn  e x a m i n a t i on  c e r t i f i c a t es  and  a d d i t i o ns 

Issued 

the  EC  d e s i gn  e x a m i n a t i on  c e r t i f i c a t es  and  a d d i t i o ns 

r e f u s ed 

the  EC  d e s i gn  e x a m i n a t i on  c e r t i f i c a t es  and  a d d i t i o ns 

w I t h d r a wn 

-  85  -

ANNEX  X 

M o d u l e:  EC  unit  v e r i f i c a t i on 

1. 

T h is 

m o d u le 

d e s c r i b es 

the 

p r o c e d u re 

w h e r e by 

the 

m a n u f a c t u r er  e n s u r es  and  d e c l a r es  that  the  equipment  or,: 

p r o t e c t i ve  system,  which  has  been 

issued  with  the 

c e r t i f i c a te  referred  to  in  point  2,  c o n f o r ms  to  the 

relevant 

r e q u i r e m e n ts 

of 

the 

d i r e c t i v e.  The 

m a n u f a c t u r er  shall  affix  the  CE  mark  to  the  equipment 

or  p r o t e c t i ve  system 

and  draw  up  a  d e c l a r a t i on  of 

conform Ity . 

2. 

The 

n o t i f i ed 

body 

shall 

e x a m i ne 

the 

Individual 

e q u i p m e nt 

or  p r o t e c t i ve 

system 

and  carry 

out 

the 

a p p r o p r i a te 

tests 

as 

set 

out 

In 

the 

relevant 

s t a n d a r d ( s)  referred  to  in  article  5,  or  equivalent 

t e s t s,  to  ensure 

Its  c o n f o r m i ty  with  the 

relevant 

r e q u i r e m e n ts  of  the  d i r e c t i v e.  The  n o t i f i ed  body  shall 

a f f i x,  or  cause  to  be  a f f i x e d, 

its 

I d e n t i f i c a t i on 

symbol  on  the  approved  equipment  or  p r o t e c t i ve  system 

and 

shall 

draw 

up 

a 

c e r t i f i c a te 

of 

c o n f o r m i ty 

c o n c e r n i ng  the  tests  carried  o u t. 

3. 

The  aim  of  the  technical  d o c u m e n t a t i on  is  to  enable 

c o n f o r m i ty  with  the  r e q u i r e m e n ts  of  the  d i r e c t i ve  to  be 

a s s e s s ed  and  the  d e s i g n,  m a n u f a c t u re  and  o p e r a t i on  of 

the  equipment  or  p r o t e c t i ve  system 

to  be  u n d e r s t o o d. 

The  d o c u m e n t a t i on  shall  c o n t a i n: 

a  general  d e s c r i p t i on  of  the  product 

conceptual 

design  and  m a n u f a c t u r i ng  d r a w i n gs  and 

s c h e m es  of  c o m p o n e n t s,  s u b - a s s e m b l i e s, 

c i r c u i t s, 

etc . 

d e s c r i p t i o ns 

and  e x p l a n a t i o ns 

n e c e s s a ry 

for 

the 

u n d e r s t a n d i ng  of  said  d r a w i n gs  and  s c h e m es  and  the 

o p e r a t i on  of  the  equipment  or  p r o t e c t i ve  system. 

-  86  -

a 

list  of  the  s t a n d a r ds  r e f e r r ed  to  in  a r t i c le  5, 

a p p l i ed  In  full  or  In  p a r t,  and  d e s c r i p t i o ns  of  the 

s o l u t i o ns  a d o p t ed  to  meet  the  e s s e n t i al  r e q u i r e m e n ts 

of  the  d i r e c t i ve  w h e re  the  s t a n d a r ds  r e f e r r ed  to  In 

a r t i c le  5  have  not  b e en  a p p l i ed 

r e s u l ts  of  d e s i gn  c a l c u l a t i o ns  m a d e,  e x am I n a t i o ns 

carr I ed  out , etc . 

test  r e p o r t s. 

-  87  -

ANNEX  XI 

Conformity  marks  and  additional  specific  markings 

1 .  EC  conformity  mark 

The  EC  conformity  shall  consist  of  the  letters  CE  as  the 

symbol  shows  below  and  the  last  two  figures  of  the  year 

In which  the  mark  was  affixed. 

C€ 

2. 

Additional  specific  markings 

Additional  markings  must  enable  full!  Identification  of 

equipment  and  protective  systems  to  be  made.  They  must  at 

least  contain  the  following: 

specific  explosion  protection  mark 

together  with 

the 

mark 

Indicating 

the 

equipment 

group, 

the 

conformity  category  thereof  and,  relating  to  equipment 

group 

11,  the 

letter 

"G" 

(concerning 

explosive 

atmospheres  caused  by  gases,  vapours  or  hazes)  and/or 

"D"  (concerning  explosive  atmospheres  caused  by  dust) 

as,  for  example,  shown  below; 

name 

and 

address 

of 

the 

manufacturer 

or 

his 

I dent I fI cat ion  mark ; 

type  and  serial  number; 

restricted  or  other  safety-related  conditions  of  use; 

I  1  G 

-  88 

ANNEX  XI I 

MINIMUM  C R I T E R IA  TO  BE  TAKEN  INTO  A C C O U NT  BY  MEMBER  STATES 

FOR  THE  N O T I F I C A T I ON  OF  BODIES 

1. 

The  body,  its  director  and  the  staff  r e s p o n s i b le  for 

carrying  out  the  v e r i f i c a t i on  tests  shall  not  be  the 

d e s i g n e r, 

m a n u f a c t u r e r, 

supplier 

or 

Installer 

of 

equipment  and  p r o t e c t i ve  systems  which  they  inspect, 

nor  the  a u t h o r i z ed 

r e p r e s e n t a t i ve  of  any  of 

these 

p a r t i e s.  They  shall  not  become  either  involved  directly 

or 

as 

authorized 

r e p r e s e n t a t i v es 

In 

the 

d e s i g n, 

c o n s t r u c t i o n,  m a r k e t i ng  or  m a i n t e n a n ce  of  e q u i p m e nt  and 

p r o t e c t i ve 

s y s t e m s. 

This 

does 

not 

p r e c l u de 

the 

p o s s i b i l i ty 

of 

e x c h a n g es 

of 

technical 

Information 

between  the  m a n u f a c t u r er  and  the  body. 

2. 

The  body  and  Its  staff  shall  carry  out  the  v e r i f i c a t i on 

tests  with  the  highest  degree  of  professional  Integrity 

and  technical  c o m p e t e n ce  and  shall  be  free  from  all 

p r e s s u r es 

and 

I n d u c e m e n t s, 

p a r t i c u l a r ly 

f i n a n c i a l, 

which  might  Influence  their  Judgement  or  the  r e s u l ts  of 

the  Inspection,  e s p e c i a l ly  from  persons  or  g r o u ps  of 

p e r s o ns 

with 

an 

Interest 

In 

the 

result 

of 

ver i f I cat i o n s. 

3. 

The  body  shall  have  at  Its  disposal  the  n e c e s s a ry  staff 

and  p o s s e ss  the  n e c e s s a ry  facilities  to  e n a b le  It  to 

perform  properly  the  a d m i n i s t r a t i ve  and  technical  tasks 

connected  with  v e r i f i c a t i o n;  it  shall  also  have  access 

to  the  equipment  required  for  special  v e r i f i c a t i o n. 

-  89  -

The  staff  r e s p o n s i b le  for  Inspection  shall  h a v e: 

-  sound  technical  and  professional  t r a i n i n g, 

s a t i s f a c t o ry  k n o w l e d ge  of  the  r e q u i r e m e n ts  of  the 

tests  they  carry  out  and  a d e q u a te  e x p e r i e n ce  of  such 

t e s t s, 

the  ability  to  draw  up  the  c e r t i f i c a t e s,  r e c o r ds  and 

r e p o r ts  required  to  a u t h e n t i c a te  the  p e r f o r m a n ce  of 

the  t e s t s. 

The 

Impartiality 

of 

inspection 

staff 

shall 

be 

g u a r a n t e e d.  Their  r e m u n e r a t i on  shall  not  depend  on  the 

number  of  tests  carried  out  or  on  the  r e s u l ts  of  such 

t e s t s. 

The  body  shall  take  out  liability  insurance  u n l e ss  Its 

liability  is  assumed  by  the  State  In  a c c o r d a n ce  with 

national  law,  or  the  Member  State  Itself  is  directly 

r e s p o n s i b le  for  the  t e s t s. 

The  staff  of  the  body  shall  be  bound 

to  o b s e r ve 

p r o f e s s i o n al  secrecy  with  regard  to  all 

information 

gained  In  carrying  out  Its  tasks  (except  v i s - à - v is  the 

competent  a d m i n i s t r a t i ve  a u t h o r i t i es  of  the  State  in 

w h i ch 

Its  a c t i v i t i es 

are  carried 

o u t)  under 

this 

D i r e c t i ve  or  any  p r o v i s i on  of  national 

law  giving 

effect  to  It. 

-  90 -

FINANCIAL  STATEMENT 

SECTION  1:  FINANCIAL  IMPLICATIONS 

1. Title of opérât Ion 

Approximation  of  the  laws  of  the  Member  States  concerning  equipment  and 
protective  systems  Intended  for use  In potentially explosive atmospheres. 

2. Budget  heading  Involved 

Article B5-300: completing  the  Internal  market. 

3. Legal  basis 

Article  100a of  the Treaty 
Council  Resolution  of  7 May  1985  concerning  a  new  approach  to  technical 
harmonization and  standardization. 

4. Description of  operation 

The planned  operation  consists of  contributing  to the drafting  and prevision 
of  harmonized  standards  which  will  facilitate  the  appiIcatIon • of  the 
directive and  Increase  the competitiveness of  European  Industry. 

5. Classification of  expenditure 

Differentiated  appropriation 
Non-compulsory expenditure. 

6. Type of  expenditure 

The  above  proposal  defines  essential  safety  and  health  requirements. 
Article 5 of  It refers to harmonized  standards. 

-  91  -

As with  the other  "New Approach"  directives,  the Commission  plans  to assign 
to  CEN/CENELEC  the  task  of  preparing  useful  harmonized  standards.  The 
mandate  required  for  this  task  falls  within  the  framework  contract  signed 
on  10 October  1985,  which  provides  for  financial  support  from  the 
Commission. 

7. Financial  Impact  on  appropriations  for  operations 

7.1 

Method  of  calculation 

(a) 

CENELEC 

CENELEC  is  currently  following  a  policy  aimed  at  decreasing  the 
number  of  operations  carried  out  by  the  Commission  and  the 
EFTA  Secretariat.  The  amounts  invoiced  for  the  preparation  of 
CENELEC  standards  can  therefore  be  considered  to  be  token  values 
which  are  30-40% of  the  actual  costs.  On  this  basis,  an  Initial 
estimate  shows  that  30 standards  need  to  be  revised  (actual  costs 
ECU  600 000,  of  which  ECU  240 000  has  been  Invoiced)  and  20  new 
standards  will  be  needed  (actual  costs  ECU  576 000,  of  which 
ECU  128 000  has  been  Invoiced).  The  actual  cost  of  the  programme 
amounts  to  ECU  1 176 000,  of  which  ECU  368 000  has  been  invoiced. 
The  Impact  on  the  Commission  budget  is  therefore  currently 
estimated  to  be  ECU  368 000.  The  average  price  of  a  CENELEC 
standard  is ECU 7 360. 

(b) 

CEN 

-  92 -

The  same  policy  is  not  followed  by  CEN,  however.  The  method  of 
financing  calculated  on  the  basis  of  experience  with  existing 
mandates  shows  that  each  new  standard  costs  the  Commission  an 
average  of  ECU  50 000.  The  number  of  A/B  (product  families)  CEN 
standards  Is provisionally  put  at  25.  However,  a  safety  margin  of 
five  additional  standards  has  to  be  allowed.  The  total  impact  of 
the  programme 
is  therefore  estimated  to  be  30  standards 
representing  expenditure of  ECU  1.5 million. 

(c) 

7.2 

1992 
1993 
1994 
1995 

has  been  made 

in  collaboration  with 

The  total  number  of  (CEN  +  CENELEC)  standards  is 80.  The  overall 
expenditure  can  be  estimated  to  be  a  maximum  of  ECU  1 868 000. 
This  estimate 
the 
standardization bodies.  The  technical  structures  In the electrical 
field  have  been  in  place  for  a  number  of  years,  which  means  that 
undoubtedly  more  unreliable  data  can  be  obtained.  This  is  not 
always  the  case  with  non-electrical  standardization  most  of  which, 
although  some  work  Is  in progress,  in  particular  supported  by  the 
"machinery"  mandate,  Is still  unchartered  territory  due  to  lack of 
experience  and  In  particular  of  technical  forums  in  which  the 
experts  are  able  to  cooperate.  The  CEN  amounts  should  be 
light 
considered 
The  amount  is to be spread  over  four  years. 

this. 

the 

in 

of 

Schedule 
appropriations  (PA) (Article  B5-300 

commitment 

of 

appropriations 

(CA) 

and 

payment 

CA 

PA 

1 868 000 

198 000 

678 000 
744 000 
248 000 

TOTAL 

1 868 000 

1 868 000 

-  93 -

SECTION 2:  ADMINISTRATIVE  EXPENDITURE 

The  proposal  for  a directive  replaces  and  extends  the  existing  directives. 
The  incorporation  of  non-electrical  equipment  and  mining  equipment,  which 
Is currently  dealt  with  by  DG V/E-4  (Secretariat  of  the  Safety  and  Health 
Commission  for  the  Mining  and  Other  Extractive  Industries,  will  create  a 
need  for  one  additional  A-1 eve I official  to  be  appointed  either  by  way  of 
internal  mutation,  or  by  the  Commission  within  the  framework  of  the 
allocation  of  resources. 
He  will  be  responsible  for  ensuring  the 
application  of  the  directive,  providing  technical  liaison  between  the 
Commission  and  standardization  and  matters  of  interpretation  of  the 
essential  requirements  and  monitoring  the  work  of  DG V  concerning  the 
Article  118a directive.  He will  also attend  the meetings of  the Safety  and 
Health Commission. 

-  94 -

SECTION 3:  ELEMENTS OF COST-EFFECTIVE  ANALYSIS 

The  aim  of  the  proposed  operation  Is  fui I  harmonization  of  the  ATEX 
(electrical) sector  In accordance with  the statement  entered  In the minutes 
of  the meeting  of  which  optional  Directive  79/196/EEC  was  adopted.  It  is 
therefore  an obligation  for which  no  alternative  has been  considered.  The 
extension  to  Include  other  equipment  meets  technical  safety  requirements 
and  is  in  keeping  with  the  Council  Resolution  of  7 May  1985  to  avoid  a 
large number of specific directives. 

It can be noted  that  about  20 standards  have  already  been  produced  for  the 
electrical  field,  many  of  which  are  Included  In  the  technical  annexes  to 
Directive 79/196/EEC,  82/130/EEC  and  90/487/EEC.  A  simple  revision  of 
these  standards  and  the  inclusion  of  any  specific  measures  to  meet  new 
essential  safety  requirements  may  suffice  in many  cases.  In  addition,  a 
large  number  of  I EC  publications  (In  particular  the  79 series)  have 
appeared  since  work  began  In 1948.  These  will  continue  to  provide  a  firm 
basis for European standardization activities. 

Furthermore,  the  work  of  WG  16  of  CEN/TC  114  (Fire  and  Explosions)  which 
was set up under  the mandate of Directive 89/392/EEC  (machinery), has to be 
taken  Into account  for  the non-electrleal  field.  The standards produced by 

.the committee concerned will  apply almost  directly  to the ATEX Directive. 

The  above  considerations  will  reduce  the  number  of  new  standards  needed 
and, therefore, the  Impact on  the Commission budget. 

v 

The figures given are approximate only. 

-  95 -

IMPACT ASSESSMENT  SHEET 

IMPACT OF THE PROPOSAL  ON UNDERTAKINGS  AND, 
IN PARTICULAR, ON SMALL  AND MEDIUM-SIZED  UNDERTAKINGS  (SMUs) 

1. Principal  grounds  for  the proposal 

This  proposal  for  a  directive  is  aimed  at  the  full  harmonization  of 
equipment  and  protective  systems  Intended  for  use  In potentially  explosive 
by 
atmospheres.  It 
Directive  76/117/EEC, 79/196/EEC, 90/487/EEC  and  82/130/EEC, which  will  be 
made  complete  and  provides  for  a  widening  to  Include  equipment  and 
protective  systems  not  covered  by Community  legislation. 

Introduced 

optional 

Includes 

system 

the 

2.  Impact on  undertakings 

2a 

Characteristics of  the undertakings  concerned 

There  are  a  considerable  number  of  SMUs  in  the  field  of  equipment  for  use 
In potentially  explosive  atmospheres.  The  high  level  of  specialization  In 
this  field  has  enabled  relatively  small  undertakings  to  coexist  with  the 
specific  production  lines of  the  major  equipment  manufacturers.  The  main 
manufactures  are  in France, Germany  and  the  UK,  and  users  are  to  be  found 
in  all  countries  with  an  industrial  (chemicals,  oil)  and  mining  sector. 
Production  of  such  equipment  Is tending  to decline  following  pit  closures. 
Greater  and  continuously  Increasing  interest  Is now  being  shown  in surface 
equipment,  however.  As  a  result  of  restructuring  in  the  sector  concerned 
and  gearing  it  towards  Industrial  applications,  European  equipment  has  an 
excellent  reputation  and  can  only  benefit  from  a  larger  market,  not  only 
within  the  Community  but  also  in the  EFTA  countries  and  as  regards  exports 
to  North America  and  other  countries  concerned  with  the  exploitation  of 
mineral  resources. 

Are  there  concentrations  In  regions  eligible  for  regional  aid  from  the 
Member  States?  No 

Are  there concentrations  In regions eligible under  the  ERDF?  No 

-  96  -

However,  It  should  be  stated  that  subsidies  have  made  It  possible  to 
maintain  certain  mining  activities  and  therefore  to  safeguard  local 
Industries which  supply  group  I equipment. 

3. The  obligations  on  undertakings 

The  existing  optional  directives  guaranteed  free  movement  of  some 
electrical  equipment  within  the  Community.  Companies  were  not  unaware  of 
this  commercial  advantage,  which  was  symbolized  by  the  affixing  of  the 
highly  estimated  Commun!ty  mark  epsilon- 
.  The  general  possibility  of 
free  movement  for  the  bulk  of  equipment  and  systems  produced  for  use  in 
potentially  explosive  atmospheres  must  be  regarded  as  an  additional  asset. 
It was  found  during  the  (modest)  extension  of  the  existing  directives  that 
all  of  the  parties  concerned  approved  and  that  national  legislation  or 
standardization  were  systematically  abandoned. 

Since  European  standardization  exists,  the  need  for  conformity  with 
different  national  provisions  and  the  inherent  costs  disappear.  The 
apparently  new  obligations  contained  In  the  new  directive  will  ultimately 
only  replace  those  existing  at  the  national  level  and  will  help  to  reduce 
the  diversity  of  existing  regulations. 

4. What  are  the  foreseeable  effects 

on  employment? 

The  effects  on  employment  will  tend  to  be  Indirect.  The  fact  Is -
and  this  has  been  confirmed  by  experience  In the  electrical  field  -
that  the  production  of  high-quality  equipment  is an  important  asset 
which  extends  even  beyond  the  Community's  frontiers.  The  effect  on 
employment,  taking  account  of  the  high  level  of  specialization  of 
the  SMUs  working  In the  field,  may  therefore  be  beneficial. 

on 

the 

compet it Iveness 

of 

undertakings? 

The  reduction  in  the  number  of  certificates  to  be  obtained  for  the 
same  Item  of  equipment  and  the  associated  savings,  In  particular 
for  non-electrical  equipment,  as  a  result  of  not  having  to  repeat 
Increase 
tests  will  put  a  limit  on  the  total  price  and 
competitiveness while  guaranteeing  equivalent  quality. 

-  97  -

5. Will  there  be  special  measures  for  SMUs? 

No.  However,  the  directive  does  provide  for  the  checking  of  Individual 
units  to  certify  conformity,  which  may  be  a  satisfactory  solution  for 
special  equipment  made  In  limited  numbers  for  part leu Iar  app11 cat ions. 

6.  Have  the  two  sides of  Industry  been  consulted? 

The  proposed  directive  has  been  discussed  with  experts  from  the  industrial 
federations  (ORGALIME,  ECCMF,  FITMT)  and  European  standardization  In  which 
all  of  the  Interests  concerned  are  represented.  Furthermore,  the  Mines 
Safety  and  Health  Commission  and  the  Advisory  Committee  on  Safety,  Hygiene 
and  Health  Protection  at  Work  have  been  fully  consulted. 

consensus 

discussions.  Electrotechnlcal 
A  broad 
standardization 
Its 
non-electrical  partner  (CEN)  Is at  the  moment  preparing  a  generic  standard 
in  Its  field  under  the mandate  of  the  "machinery"  directive. 

from 
emerged 
(CENELEC)  has  a 

the 
large  number 

standards, 

of 

It  Is only  structures  which  from  the  beginning  have  been  completely  divided 
Into  electrical  and  mechanical  sections  (industrial  federations,  some 
administrations)  which  find  some  difficulty  In  accepting  the  generalizing 
approach  of  the  proposal. 

However,  the  committees  which  Include  the workers'  trades  unions  approve  of 
this  approach  for  safety  reasons. 

ISSN 0254-1475 

COM(91) 516  final 

DOCUMENTS 

EN 

04  06 

Catalogue number : CB-CO-91-591-EN-C 

ISBN 92-77-78935-2 

Office for Official Publications of the Europeaa Communities 
L-2985 Luxembourg