Proposal for a COUNCIL DIRECTIVE on transportable pressure equipment
Date: 1997-01-08
Institutions: European Commission
Subjects: EC conformity marking, approximation of laws, pressure equipment, safety standard, transport of dangerous goods

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 08.01.1997 
COM(96) 674  final 

97/0011 (SYN) 

Proposal for a 

COUNCIL DIRECTIVE 

on transportable pressure equipment 

(presented  by the Commission) 

EXPLANATORY  MEMORANDUM 

A.  General  introduction 

1.  This proposal has as its primary objective safety in the transport of transportable pressure 
equipment.  Although'the Council has already ensured, by adoption of Directives 94/55/EC1 
and  96/49/EC2,  a  sufficiently  high  level  of  safety  in  the  transport  of  dangerous  goods  -
including transportable pressure equipment - the aspect of free provision of transport services 
involving  such  equipment,  including  use and  refilling,  is  not guaranteed.  That  is  to  say, 
there  are  additional  national  requirements  which  impede  the  free  provision  of  transport 
services  for  such  equipment,  as  well  as  its  use.  These  restrictions  are  mainly  due  to the 
absence  of  a harmonised  system  for  approvals  for  such equipment  at the time  of  periodic 
inspections  in use,  and consequently  to a lack of recognition of approvals  and marks  issued 
by inspecting bodies.  Thus, the approval attesting the periodic inspection of the equipment 
as  carried  out by  a designated  inspection body  in one Member  State  should  be recognised 
throughout  all Member  States.  This contrasts  to the current  situation where,  for  example, 
gas cylinders transported  from country x to country y and used may not be refilled  in country 
y and transported  back again to country x without being retested,  inspected and approved in 
country y. 

Therefore,  although by Council Directives 94/55/EC and 96/49/EC great progress  has been 
made  in harmonising  technical  provisions  for  the  safe  transport  of  transportable  pressure 
equipment, particularly  with regard to construction and use, certain measures  still remain to 
be taken.  Although a limited number of Member States already operate a voluntary form of 
mutual  recognition  of  approvals  for  transportable  pressure  equipment  for  both  periodic 
inspections  and  placing  on  the  market,  without  requiring  further  testing,  there  is  no 
mandatory  requirement  obliging Member  States to do so, so that unfortunately  obstacles  to 
freedom to provide transport services still exist where other Member States require additional 
inspection  of  approved  equipment  for  use  on  their  territory  in  the  course  of  a  transport 
operation. 

Council  Directive  94/55/EC  of  21  November  1994  on the  approximation  of  the  laws  of  the  Member  States  with  regard  to  the 
transport  of  dangerous  goods  by  road  OJ  L  319/7,  12.12.94 

2 

Council  Directive  96/49/EC  of 23 July  1996 on the approximation  of the laws of the Member States with  regard  to the  transport 
of  dangerous  goods  by  rail,  OJ  L 235/25,  17.9.1996 

2.  A secondary objective is to ensure free circulation of such equipment on the Community 
market.  Although the Council recently  adopted Directive 96/../EC3,  covering the aspect of 
placing on the market of pressure  equipment, this Directive excludes transportable pressure 
equipment  from  its  scope,  given that most technical  aspects  are already  covered  under  the 
scope of Council Directives 94/55/EC and 96/49/EC. In its original proposal to the Council 
for this Directive on pressure equipment (COM(93)319), the Commission already announced 
that Community measures would be taken to ensure free circulation and use of transportable 
pressure  equipment  where  these  aspects  were  not  addressed  through  Council  Directive 
94/55/EC  (see  III,  pg  lb  of  COM(93)319).  Thus,  this  proposal  will  likewise  seek  to 
overcome  the  additional  national  requirements  which  impede the placing  on the market of 
transportable  pressure  equipment,  through  the  establishment  of  uniform  requirements  for 
construction  and  use,  taken  from  Directives  94/55/EC  and  96/49/EC,  recognition  of 
certification  issued  by approved bodies and the inclusion of a mark of  conformity. 

3.  In  order  to  fullfil  the  above  objectives,  this  proposal  provides  for  a  guarantee  of 
transport  safety  by  introducing  new  procedures  for  periodic  inspection  of  all  existing 
transportable  pressure  equipment  in  Annex  V,  part  II,  as  well  as  conformity  assessment 
procedures  following the modular approach in Annex V, part I, for  all new equipment other 
than that manufactured  in accordance with Council  Directives  84/525/EEC4,  84/526/EEC5 
and 84/527/EEC6. 

Freedom  to  provide  transport  services  will  be  fully  attained  if,  as  a  result  of  the 
harmonisation  provided  by this proposal,  new transportable  pressure  equipment  as well as 
all  existing  equipment  which  complies  with  Council  Directives  94/55/EC  and  96/49/EC, 
including  cylinders  manufactured  in  conformity  with  Council  Directives  84/525/EEC, 
84/526/EEC and 84/527/EEC, used in the context of a transport operation will be recognised 
in other  Member  States. 

4.  Existing  equipment,  manufactured  to  national  standards,  that  does  not  comply  with 
Council Directives 94/55/EC  and 96/49/EC, does not fall within the scope of this proposal. 

5.  There  are large numbers  of testing  and certification  houses  currently  existing  in the 15 
Member  States, which under this proposal would take on the status of designated  inspection 
bodies  on  condition  that  they  meet  the  relevant  criteria.  This  proposal  provides  that  the 
inspection  bodies  have  to  fulfill  common  quality  criteria  to  be  designated  by  the  national 
administrations.  The basis of these criteria  is taken from  the newly developed and adopted 
CEN  standard  in  the  EN  45000  series,  namely  EN  45004  adopted  in  1995  laying  down 
"General  criteria  for  the operation  of various types of bodies performing  inspection". 

3 

4 

5 

6 

Council  Directive 96/../EC  on the approximation  of the laws of the Member States concerning  pressure equipment,  OJ L  ...,  .... 

OJ  L  300/1,  19.11.1984 

OJ  L  300/20,  19.11.1984 

OJ  L  300/48,  19.11.1984 

6.  A positive effect  of this proposal is the granting of access to a larger market for products 
falling  within  its  scope  with  the  twofold  benefit  of  economies  of  scale  and  reduced 
administrative costs related to approval of transportable pressure equipment.  Such equipment 
should be easily  identifiable  to facilitate  further  its circulation.  The most effective  way to 
do  so  is  to  affix  a  distinguishing  mark  to  it  (see  Annex  VII).  Each  Member  State  shall 
recognise  all equipment bearing  such  a mark,  since  it is  a guarantee  of compliance  of  the 
equipment  with  the  requirements  of  this  proposal,  that  is,  a guarantee  of  a high  level  of 
safety  of the equipment. 

7.  As regards  economic  advantages  of this Directive  over the current  situation,  today  the 
situation  of  type approval  for  transportable  pressure  equipment  is such that  manufacturers 
have to submit their equipment for type approval to the national administration of all Member 
States where they intend to place their product on the market.  Once this Directive enters into 
force,  they  will  not  be  obliged  to  obtain  approval  from  all  Member  States  individually; 
approval  and marking  in one Member  State will be enough to place the  equipment  on the 
market  or use  it in any part  of the Community. 

8.  Equipment  transported  into  the  Community  from  third  countries  can be  approved  for 
periodic  inspection  by  a  designated  inspection  body  established  within  the  Community 
provided that this equipment satisfies  the provisions of this Directive.  Also, new equipment 
manufactured  in third countries and placed on the Community market for the first  time must 
comply  with the provisions  of this Directive. 

9. In developing its proposal the Commission consulted Member States' governments, as well 
as  European  trade  federations  such  as  AEGPL,  EIGA,  CEFIC,  ECM,  EPTA,  UIP,  the 
representative bodies of inspecting agencies, CEOC and ECUI, and the standardisation body 
CEN, who in principle all agree on the need for regulation at Community level in this sector 
in order  to enhance  safety  and speed up the procedures  for  type approval  of  equipment. 

B.  Justification  for  action at Community level 

Subsidiarity 

(a)  What  are  the  objectives  of  the proposed  action  in relation  to  the  Community's 

obligations? 

The main objective of the action envisaged  is to facilitate the freedom  to provide 
transport  services and to enhance safety  in the transport of transportable pressure 
equipment within the Community.  In addition, the proposal regulates the placing 
on the market of new equipment.  All this can be achieved through a recognition 
of  approvals  issued  by  Competent  Authorities'  testing  bodies  (designated 
inspection bodies), whether independent or in-house, and by affixing  a recognised 
mark  for  approved  equipment. 

(b) 

Does competence for  the planned activity  lie solely  with the Community  or  is it 
shared  with the Member  States? 

It  is  a competence  shared  between  the  Community  and  the  Member  States. 

(c)  What  is  the  Community  dimension  of  the  problem  (for  example,  how  many 
Member  States  are  involved  and  what  solution  has  been used  up  to  now)? 

All  Member  States  are  already  bound  by  Council  Directives  94/55/EC  and 
96/49/EC  which  establish  the  technical  requirements  for  the  transport  of 
dangerous  goods  including  transportable  pressure  equipment.  Further  to  these 
obligations  Member  States will need to transpose  the provisions  of this  Directive 
in  order  to  adequately  cover  the  aspects  of  placing  on  the  market  and  periodic 
inspections  of  these  goods  within  the  Community. 

(d)  What  is the most effective  solution taking into account the means  available to the 

Community  and  those  of  the  Member  States? 

Action at  Community  level  is the only  possible  way  to solve  these problems.  A 
mutual  recognition  clause  in  the  Council  Directives  94/55/EC  and  96/49/EC 
would  be  insufficient  given  that,  for  the  purposes  of  transport,  a  cylinder,  for 
example,  can  already  be  approved  in  one  Member  States  then  filled  and 
transported  to  another  Member  State.  The  obstacle  arises  in  the  course  of  a 
transport  operation  when the cylinder  needs  to be  refilled  and  moved  again.  At 
this  stage  Member  States  require  their  own Competent Authority  approval  of the 
testing  of  transportable  pressure  equipment. 

Therefore  the  completion  of  the  Internal  Market  for  transportable  pressurised 
equipment,  as foreseen  in Article  8A of the  EEC  Treaty,  calls  for  measures  that 
can  only  be  taken  satisfactorily  at  Community  level  in  order  to  achieve  this 
objective. 

(e)  What  real  added  value will  the activity proposed  by the  Community  provide  and 

what  would  be  the  cost  of  inaction? 

A  positive  effect  of  the  principle  of  recognition  of  approvals  of  the  equipment 
established  in the Directive will be the free provision of transport  services  of such 
equipment  throughout  the  Community,  as  well  as  the  elimination  of  the 
unnecessary  costs  and  administrative  procedures  related  to  the  equipment 
approvals. 

As regards economic advantages of this Directive over the current situation,  today 
the  situation  of  type  approval  for  transportable  pressure  equipment  is  such  that 
manufacturers  have  to  submit  their  equipment  for  type  approval  to  the  national 
administration  of  all Member  States  where  they  intend  to place  their  product  on 
the  market.  These  manufacturers  already  have  to  bear  the  costs  related  to 
conformity  assessment.  Once  this  Directive  enters  into  force,  they  will  not  be 
obliged  to  obtain  approval  from  all  Member  States  individually;  approval  and 
marking  in  one  Member  State  will  be  enough  to  place  the  equipment  on  the 
market  or  use  it in any  part  of the Community.  The  consequent  savings  may  be 
reflected  in the  price  of  the  equipment. 

Moreover,  the  approval  attesting  the  periodic  inspection  of  the  equipment  as 
carried  out  by  a  designated  inspection  body  in  one  Member  State  should  be 
recognised throughout all Member States.  This contrasts to the current  situation 
where,  for  example, gas cylinders  transported  from  country x  to country y  and 
used  may  not  be refilled  in country y  and  transported  back  again  to  country  x 
without being retested,  inspected  and approved  in country  y. 

Embracing certain tanks for the transport of dangerous goods within the scope of 
this  proposal,  thereby  assuring  them  free  circulation,  has  important  economic 
advantages considering  the high value of such equipment. 

A further  advantage of recognition of approvals is that it will allow better use of 
existing equipment.  For example, where a company has premises  in more than 
one  country,  transportable  pressure  equipment  in  excess  in  country  x  can  be 
transferred  to country y for use without incurring additional costs for  inspection 
by the designated  inspection body of country  y. 

(f)  What forms of action are available to the Community (recommendation,  financial 

support,  regulation,  mutual recognition,  etc...)? 

Action at international level is insufficient  in the absence of efficient  enforcement 
possibilities. 

It is considered that a Directive is the best means available of achieving the goal 
of free  circulation of this transportable  pressure  equipment.  A Directive would 
allow the flexibility  of  amending existing  national  rules  rather  than abandoning 
these  for  a Regulation.  A recommendation  is considered  insufficient  given the 
sensitive safety aspects involved in this transport.  Financial support would clearly 
be inadequate. 

(g)  -  Is  it  necessary  to  have  a uniform  Regulation  or  is  a  Directive  setting  out  the 
general objectives  sufficient,  leaving implementation at the level of the Member 
States? 

The adoption of a Council Directive is the appropriate procedure for laying down 
a  legal  framework  to enhance  safety  performances  of  the equipment  through a 
uniform and compulsory application of the technical provisions for the equipment 
as set out in the Annexes to Directives 94/55/EC and 96/49/EC, while leaving to 
the  Member  States  the  means  of  enforcement  and  the  implementation  of  this 
Directive. 

Coherence with other  Community policies 

This proposal  for  a Directive  will  fill  the legislative  gap currently  existing  with regard  to 
harmonised  conditions  for  a  Single  Market  in  transportable  pressure  equipment,  as  it 
complements  not  only  existing  Community  legislation  with  regard  to  the  transport  of 
dangerous goods but also that which establishes  a Single Market for pressure  equipment in 
general. 

C.  Scope of the proposal 

This  proposal  requires  that  all transportable  pressure  equipment  used  for  the  transport  of 
dangerous goods meets the provisions  relating to such equipment in the Annexes to Council 
Directives 94/55/EC and/or 96/49/EC. (For the purposes of manufacture and type approval, 
cylinders  covered  under  Directives  84/525/EEC,  84/526/EEC  and  84/527/EEC  already 
satisfy  these  requirements.) 

In  addition,  new  equipment  equipment  has  to  be  subjected  to  the  conformity  assessment 
procedures  set out in Annex V, part I,  approved by a recognised  inspection body,  in order 
to bear the mark  set out in Annex VII. 

Existing  equipment  meeting  the  provisions  set  out  in  the  Annexes  to  Council  Directives 
94/55/EC  and  96/49/EC  with  regard  to periodic  inspection  may  bear  the  mark  set  out  in 
Annex VII  if the testing  and  inspection  is carried  out by a recognised  inspection body and 
the tests  are carried  out in accordance  with Part II of Annex V. 

It  covers  existing  equipment,  including  receptacles  and  tanks  of  Class  2,  used  for  the 
transport  of  gases  of  Class  2  as  well  as  stabilized  hydrogen  cyanide  of  Class  6.1  and 
hydrogen  fluoride,  anhydrous  and  hydrofluoric  acid  solution  of  Class  8  transported  in 
receptacles  of Class 2. 

Under  Council  Directives  94/55/EC  and  96/49/EC  already  today  most  "packagings", 
including tanks, containing dangerous goods bear a "UN" mark.  But this is not the case for 
packagings  for  gases  (Class  2),  e.g.  cylinders, 
tubes,  which  have  no  widely 
recognised/uniform  mark. 

A new  mark  is  being  proposed  here  for  all new  transportable  pressure  equipment  for  the 
purposes  of placing  on the market as well as for  all existing  equipment for  the purposes of 
periodic  inspection. 

Currently all gas cylinders complying with Council Directives 84/525/EEC, 84/526/EEC and 
84/527/EEC are engraved with an e mark.  However, a different  mark is being proposed  for 
such equipment  here,  because this  Directive  includes  the aspect  of conformity  assessment, 
together with the recognition of approvals issued by recognised  inspection bodies for  initial 
and periodic inspections.  So, the new mark will provide proof  of periodic inspection by an 
approved inspection body for all transportable pressure equipment covered by this proposal. 

New transportable  pressure  equipment complying with the provisions of Council Directives 
94/55/EC  and 96/49/EC and stamped with the authorized mark prescribed  by this Directive 
would  have  free  circulation  including  placing  on  the  market,  transport  and  use  in  all  15 
Member  States. 

Moreover,  existing  transportable  pressure  equipment  complying  with  the  provisions  of 
Council Directives 94/55/EC and 96/49/EC and stamped with the authorized mark prescribed 
by  this  Directive  after  periodic  inspection  would  be  able  to  be  refilled  and  subsequently 
transported  in all  15 Member States. 

Existing transportable  pressure  equipment manufactured  according to national requirements 
which do not satisfy  the provisions  of Directives 94/55/EC and 96/49/EC  is excluded  from 
the scope of this proposal. 

D.  Contents  of the proposal 

Article  1 outlines the purpose  of this proposal  and determines  its scope. 

Article 2 defines the main terms used in the proposal, including the three types of inspection 
body  taken from  EN 45004. 

Article 3 introduces the requirement for conformity assessment procedures for the equipment 
and  requires  Member  States  to  permit  free  movement  of  new  equipment  approved  and 
inspected  in  other  Member  States  where  this  equipment  satisfies  the  requirements  of  this 
Directive. 

Article 4 introduces a requirement for periodic inspection in accordance with the procedures 
set out in part II of Annex V.  It also requires  Member  States to permit free  movement of 
existing  equipment  approved  and  inspected  in other  Member  States  where  this  equipment 
satisfies  the requirements  of this Directive  and bears  the mark of Annex VII. 

Article  5  establishes  the  responsibilities  of  Member  States  in designating  notified  bodies 
(Type  A inspection bodies)  and withdrawing  approval  where the criteria  of  Annexes I and 
II are no longer  met. 

Article 6 sets  out the requirements  to be met by Type B inspection bodies. 

Article 7 sets  out the requirements  to be met by Type C inspection bodies. 

Article 8 introduces  a requirement  for  marking equipment conforming  to the requirements 
of the Directive. 

Article 9 has been designed as a safeguard  clause to cover the case where equipment is found 
by a Member State to be liable to cause damage to health or endanger safety.  Such cases will 
be handled  through  the Committee procedure  set out in Article 12. 

Article 10 covers  the case where marking  according to Article  8 has been unduly  affixed. 

Article 11 provides for  adaptation of the Annexes to the Directive by the Commission.  The 
procedure  laid down in Article  12 will apply. 

Article  12 describes  the  procedure  to  be  followed  in  the  Committee  to  be  used  by  this 
Directive. 

Article  13 establishes  the measures  with which each Member  State has to comply  in order 
to enforce  the Directive. 

Articles  14  and 15  : No comment. 

Annex  I  : Minimum  criteria  to be met when designating  inspection bodies. 

Annex  II: Supplementary  criteria  to  be  met  when  designating  notified  bodies  (inspection 
bodies of Type A). 

Annex III: Supplementary criteria  to be met when designating inspection bodies of Type B. 

Annex IV Supplementary criteria to be met when designating inspection bodies of Type C. 

Annex V:  Conformity  assessment  procedures  and Procedures  for  periodic  inspection 

Annex VI  :  Modules  to be followed  for  conformity  assessment 

Annex VII  :  Mark  of  conformity 

Proposal for a Council Directive 

on transportable pressure equipment 

THE COUNCIL  OF THE  EUROPEAN  UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 

75,1.  (c)  thereof; 

Having regard  to the proposal  from  the Commission1, 

Acting  in  accordance  with  the  procedure  referred  to  in  Article  189c of  the  Treaty  and  in 
cooperation  with the European  Parliament2, 

Having regard  to the opinion of the Economic  and Social Committee3, 

Whereas  within  the  framework  of  the  common transport  policy  further  measures  must  be 

adopted  to ensure  transport  safety; 

1  O JC 

2  O J C . .. 

3  O J C . .. 

10 

Whereas each Member State currently  requires all transportable equipment to be used on its 

territory  to  undergo  certification  and  inspection,  including  periodic  inspections,  by  its 

appointed  bodies;  whereas  this practice,  requiring  multiple approvals  if equipment  is to be 

used  in more than one State in the course of a transport  operation constitutes  an obstacle to 

the provision of transport services within the Community;  whereas action by the Community 

for  a  harmonisation  of  approval  procedures  is justified  in  order  to  facilitate  the  use  of 

transportable pressure  equipment on the territory  of another Member State in the context of 

a transport  operation; 

Whereas measures  should  be adopted  for  the progressive  establishment  of a Single Market 

in transport  and in particular,  for  free  movement of transportable  pressure  equipment; 

Whereas  action  at  Community  level  is  the  only  possible  way  of  achieving  such 

harmonisation, since Member States acting independently or through international agreements 

cannot  establish  the  same  degree  of  harmonisation  in  the  approvals  for  such  equipment; 

whereas,  currently,  recognition  of  approvals  given  in  different  Member  States  is  not 

satisfactory  because of the element of discretion; 

Whereas  a Council  Directive  is  the  appropriate  legal  instrument  to enhance  safety  in this 

equipment  as  it  provides  a  framework  for  uniform  and  compulsory  application  of  the 

approval  procedures  by  Member  States;  whereas,  in  order  to  eliminate  discretionary 

elements, it is necessary  to establish clearly in Annexes V and VI which approval procedures 

for initial and periodic inspection of the transportable pressure equipment should be followed 

by Member  States; 

11 

Whereas Council Directives  94/55/EC4 and 96/49/EC5 have extended the application of the 

provisions  of the  ADR and RID to cover  national traffic  in order  to harmonise  across  the 

Community the conditions under which dangerous goods are transported by road and by rail; 

whereas the provisions relating to transport equipment are laid down in order to facilitate the 

provision of transport  services  and that such Directives apply to the transport  of dangerous 

goods; 

Whereas Council Directives 84/525/EEC6,  84/526/EEC7 and 84/527/EEC8 on gas cylinders 

do not provide for the aspect of periodic inspection; whereas therefore this Directive imposes 

such a requirement  also to the equipment covered  by those Directives; 

Whereas  in  view  of  the  nature  of  the  risks  involved  in the use  of  transportable  pressure 

equipment  Directives  94/55/EC  and  96/49/EC  establish  a  requirement  for  certain  such 

equipment to follow procedures  for the assessment of conformity;  whereas this requirement 

should be extended to cover all new transportable pressure equipment used for  the transport 

of dangerous  goods  and falling  within the scope of Directives  94/55/EC  and 96/49/EC; 

Whereas  recognition  of  certification  of  inspection  bodies  designated  by  the  Competent 

Authority  of  a  Member  State  as  well  as  of  the  conformity  assessment  procedures  is  the 

principal  means  of  removing  these  obstacles  to  freedom  to  provide  transport  services; 

whereas  this  objective  cannot  be  achieved  satisfactorily  at  another  level  by  the  individual 

Member  States; 

4 

5 

Council  Directive  94/55/EC  on  the  approximation  of  the laws of  the Member  States  with  regard  to  the  transport  of  dangerous 
goods  by  road  of  21  November  1994,  OJ  L 319/7,  12.12.94 

Council  Directive  96/49/EC  on  the  approximation  of  the laws of  the Member  States with  regard  to  the  transport  of  dangerous 
goods  by  rail  of  23  July  1996,  OJ  L 235/25,  17.9.1996 

OJ  L  300/1,  19.11.1984 

7  O JL  300/20,  19.11.1984 

8  OJ  L  300/48,  19.11.1984 

12 

Whereas  it  is  necessary  to lay  down  common rules  to establish  recognition  of  designated 

inspection  bodies  which ensure compliance  with the provisions  of Directive  94/55/EC  and 

96/49/EC; whereas these common rules will have the effect  of eliminating unnecessary  costs 

and  administrative  procedures  related  to the approval  of  the equipment  and  of  eliminating 

technical barriers  to trade; 

Whereas  Member  States  have  to  designate  inspection  bodies  entitled  to  perform  the 

conformity  assessment procedures and periodic inspections and they also have to ensure that 

such bodies are independent, efficient  and professionally  capable to carry out their appointed 

tasks; 

Whereas  compliance  with  the  technical  provisions  of  the  Annexes  to  Council  Directives 

94/55/EC  and  96/49/EC  for  new  equipment  shall  be  proven  by  conformity  assessment 

procedures  set out in Annex V, part I;  whereas periodic  inspections  of existing  equipment 

shall be carried  out according to the procedures  set out in Annex V,  part II; 

Whereas equipment referred  to in this Directive should bear a mark to indicate its compliance 

with the requirements  of Directives 94/55/EC or 96/49/EC and this Directive and be placed 

on  the  market,  filled,  transported,  used,  refilled  and  transported  in  accordance  with  its 

intended purpose; 

Whereas  Member  States  shall  allow  transportable  pressure  equipment bearing  the mark  in 

Annex VII to move freely  on their territory,  to be placed on the market,  to be used  in the 

course of a transport operation or to be used in accordance with its intended purpose, without 

further  evaluation or technical requirements; 

Whereas it is appropriate that the Commission takes measures to limit or prohibit the placing 

on the market and use of equipment in cases where it presents  a particular  risk to safety,  in 

accordance  with the procedure  established  in Article  12,2; 

13 

Whereas a simplified  procedure involving a consultative committee must be followed for the 

purposes of administering  the safeguard  procedure of Article 9 as well as for amendment of 

the Annexes to this Directive; 

HAS ADOPTED  THIS DIRECTIVE  : 

14 

Article 1 

1.  The  purpose  of  this  Directive  shall  be to  enhance  safety  with  regard  to  transportable 

pressure  equipment approved  for  the inland transport  of dangerous goods and to ensure 

the free  movement,  including the aspects of placing on the market,  repeated putting into 

service  and use of such equipment  within the Community. 

2.  This Directive  shall apply: 

(a) 

to  new  transportable  pressure  equipment  as  defined  in  Article  2,  with  the 

exception  of  gas  cylinders  bearing  an  e  mark  in  accordance  with  Council 

Directives  84/525/EEC,  84/526/EEC  and 84/527/EEC, 

(b) 

only for  the purposes  of periodic  inspections to: 

new transportable  pressure  equipment as defined  in Article 2 bearing  a mark in 

accordance  with Annex VII of this Directive; 

new  and  existing  gas  cylinders  bearing  an e mark  in accordance  with  Council 

Directives  84/525/EEC,  84/526/EEC  and 84/527/EEC;  and 

existing transportable pressure equipment as defined in Article 2 and meeting the 

requirements of Council Directives 94/55/EC and 96/49/EC in force at 1 January 

1999. 

15 

3.  Transportable  pressure  equipment  placed  on the market  before  1 January  1999 which 

does not meet the requirements  of Council Directives  94/55/EC and 96/49/EC does not 

fall  within the scope of this Directive. 

Article 2 

For  the purposes  of this Directive: 

'transportable  pressure  equipment'  shall  mean  refillable  equipment,  including  valves  and 

other accessories  of Class 2 of the Annexes to Council Directives 94/55/EC and 96/49/EC, 

approved  for  the  transport  of  gases  of  Class  2,  as  well  as  for  the  transport  of  stabilized 

hydrogen  cyanide  of  Class  6.1  and  hydrogen  fluoride,  anhydrous  and  hydrofluoric  acid 

solution of Class 8; it shall include receptacles, demountable tanks, tank containers (portable 

tanks),  and tanks of tank wagons, tanks or receptacles  of battery vehicles and tanks of tank 

vehicles as defined  in marginals 2211 and 10014,211 and Appendices X and XI, paragraph 

1.1.3  respectively  of the Annexes to those Directives; 

'mark'  shall mean the symbol referred  to in Article  8; 

'conformity  assessment procedures'  shall mean those procedures set out in Annex V, part I; 

'notified  body  or  Type  A  inspection  body'  shall  mean a body  designated  by  the  national 

Competent Authority of a Member State in conformity with Article 5 and meeting the criteria 

of Annexes I and II; 

'Type B inspection body' shall mean a body designated by the national Competent Authority 

of  a Member  State in conformity  with Article  6 and meeting the criteria  of Annexes  I and 

HI; 

16 

'Type C inspection body' shall mean a body designated by the national Competent Authority 

of  a Member  State  in conformity  with Article 7 and meeting the criteria  of Annexes I and 

IV; 

Article 3 

1.  New transportable  pressure  equipment,  with the exception of gas cylinders bearing an e 

mark in accordance with Council Directives 84/525/EEC, 84/526/EEC and 84/527/EEC, 

placed  on  the  market  or  put  into  service  on  or  after  1 January  1999  shall  meet The 

provisions  applicable  to  equipment  of  Class  2  of  the  Annexes  to  Council  Directive 

94/55/EC  and  96/49/EC.  Compliance  of  such  transportable  pressure  equipment  with 

these provisions shall be proven exclusively in accordance with the conformity assessment 

procedures  set out in Annex V, part I and specified  in Annex VI. 

2.  Member States shall not prohibit, restrict or impede the placing on the market or putting 

into service  on their territory  of transportable  pressure  equipment referred  to in Article 

l,2(a)  which  complies  with  this  Directive  and  bears  the  marking  in  accordance  with 

Article 8,1. 

Article 4 

1.  For  transportable  pressure  equipment  mentioned  in Article  l,2(b)  compliance  of  such 

equipment  with  the  provisions  of  the  Annexes  to  Council  Directives  94/55/EC  and 

96/49/EC  shall  be  proven  exclusively  in accordance  with  the  procedures  for  periodic 

inspection  in Annex V,  part II. 

17 

2.  Member  States shall not prohibit,  restrict  or impede the use (including filling,  emptying 

and refilling)  on their territory  of transportable pressure equipment referred  to in Article 

l,2(b)  which  complies  with  this  Directive  and  bears  the  marking  in  accordance  with 

Article  8,2  indicating  that it has undergone periodic  inspection. 

Article 5 

1.  Member States shall inform the Commission and the other Member States of the notified 

bodies (Type A inspection bodies) which they have appointed to carry out the conformity 

assessment  procedures  according  to  Annex  V,  part  I,  and/or  to  perform  the  task  of 

periodic inspections according to Annex V, part II, modules 1 or 2, including the specific 

tasks  which  those  bodies  carry  out  on  behalf  of  the  competent  authority  and  the 

identification  numbers  assigned  to them beforehand  by the Commission. 

The Commission shall publish in the Official Journal of the European  Communities a list 

of  the  designated  notified  bodies  (Type  A inspection  bodies),  with  their  identification 

numbers  and  the  tasks  for  which  they  have  been  designated.  The  Commission  shall 

ensure  that this  list  is kept up to date. 

2.  Member  States shall apply the criteria set out in Annexes I and II for  the designation of 

notified  bodies  (Type  A inspection  bodies).  Each  inspection  body  shall  submit  to the 

Member  State  which  intends  to  designate  it  complete  information  concerning,  and 

evidence of,  compliance with the criteria  in Annexes I and II. 

3.  A Member State which has designated a notified body (inspection body of Type A) shall 

withdraw  such designation  if it finds  that the body no longer meets the criteria  referred 

to in 2.  It shall immediately inform the Commission and the other Member States of any 

such withdrawal  of a designation. 

18 

Article 6 

1.  Member States shall likewise inform the Commission and the other Member States of the 

Type B inspection bodies which they have appointed,  in accordance with the criteria of 

paragraph 2, to carry out periodic inspections of transportable pressure equipment defined 

in  Article  2,  to  ensure  continued  compliance  with  the  relevant  provisions  of  Council 

Directives  94/55/EC  and  96/49/EC  in  accordance  with  the  procedures  laid  down  in 

Annex V, part II, modules  1 or 2, including the specific  tasks which these bodies carry 

out on behalf of the competent authority and the identification numbers assigned to them 

beforehand  by the Commission. 

The Commission shall publish in the Official Journal of the European Communities a list 

of  the  designated  Type  B inspection bodies,  with their  identification  numbers  and  the 

tasks  for  which they have been designated.  The Commission  shall ensure  that this list 

is kept up to date. 

2.  Member States shall apply the criteria  set out in Annexes I and III for the designation of 

Type B inspection bodies.  Each inspection body shall submit to the Member State which 

intends  to  designate  it  complete  information  concerning,  and  evidence  of,  compliance 

with the criteria  in Annexes I and III. 

3.  A Member State which has designated an inspection body of Type B shall withdraw such 

a designation if it finds that the body no longer meets the criteria referred  to in paragraph 

2 above.  It shall  immediately  inform  the Commission  and the other  Member  States of 

any  such withdrawal  of a designation. 

19 

Article 7 

1.  Member States shall likewise inform the Commission and the other Member States of the 

Type C inspection bodies which they have appointed,  in accordance with the criteria of 

paragraph 2, to carry out periodic inspections transportable  pressure  equipment  defined 

in  Article  2,  to  ensure  continued  compliance  with  the  relevant  provisions  of  Council 

Directives  94/55/EC  and  96/49/EC  in  accordance  with  the  procedures  laid  down  in 

Annex V, part II, modules  1 or 2, including the specific  tasks which these bodies carry 

out on behalf of the competent authority and the identification  numbers assigned to them 

beforehand  by the Commission. 

The Commission shall publish in the Official Journal of the European  Communities a list 

of  the  designated  Type  C  inspection  bodies,  with their  identification  numbers  and  the 

tasks  for  which they have been designated.  The Commission  shall ensure  that this  list 

is kept up to date. 

2.  Member States shall apply the criteria set out in Annexes I and IV for the designation of 

Type C inspection bodies. Each inspection body shall submit to the Member State which 

intends  to  designate  it  complete  information  concerning,  and  evidence  of,  compliance 

with the criteria  in Annexes I and IV. 

3.  A Member State which has designated an inspection body of Type C shall withdraw such 

a designation if it finds that the body no longer meets the criteria referred  to in paragraph 

2 above.  It shall  immediately  inform  the Commission  and the other  Member  States of 

any such withdrawal  of a designation. 

20 

Article 8 

1.  Equipment satisfying  the provisions  of Article 3,1 shall have a mark affixed  to it by the 

manufacturer  or  his  authorized  representative  established  within  the  Community.  The 

form  of  the mark  to be used  is  set  out in Annex  VII.  This  mark  shall be  immovably 

affixed  and shall be accompanied by the identification number of the notified body (Type 

A  inspection  body)  which has performed  the conformity  assessment  procedure  on the 

equipment,  as  appropriate,  as  well  as  by  the  further  requirements  for  marking  the 

equipment  as set out in Directives  94/55/EC  and 96/49/EC. 

2.  For  the purposes  of periodic  inspections,  all transportable  pressure  equipment  referred 

to  in Article  4  shall  have the mark  set  out in Annex VII  immovably  affixed  to  it by a 

designated  Type  A  (notified  body),  B  or  C  inspection  body.  The  mark  shall  be 

accompanied by the identification  number of the body which has performed  the periodic 

inspection  of  the  equipment,  followed  by  a  letter  U  of  the  same  dimensions  as  the 

number,  to  indicate  in-use  or  in-service,  as  well  as  by  the  further  requirements  for 

marking  the equipment  as set out in Directives  94/55/EC  and 96/49/EC. 

3.  For both conformity  assessment and periodic inspections, the identification number of the 

inspection body  shall be  immovably  affixed  under  its responsibility  either  by  the body 

itself  or  by  the  manufacturer  or  his  authorized  representative  established  within  the 

Community. 

4.  The affixing  of markings on transportable pressure equipment which are likely to mislead 

third parties  with regard  to the meaning  or the graphics  of  the mark  referred  to in this 

Directive shall be prohibited.  Any other marking may be affixed  to pressure  equipment 

provided  that  the  visibility  and  legibility  of  the  marking  in  Annex  VII  is  not  thereby 

reduced. 

21 

Article 9 

Where a Member  State establishes  that equipment,  when correctly  maintained and used  for 

its  intended  purpose,  is  liable to endanger  the health  and/or  safety  of persons  and,  where 

appropriate,  domestic animals or property,  during transport and/or use, notwithstanding the 

fact  that  it  bears  a  mark,  it  shall  immediately  inform  the  Commission  and  appropriate 

measures  shall be taken in accordance with the procedure  laid down in Article  12,2. 

Article 10 

Without prejudice to Article 9, where a Member State establishes that the marking as defined 

in  Article  8  has  been  unduly  affixed,  the  manufacturer,  or  his  authorized  representative 

established  within  the  Community,  shall  be  obliged  to  make  the  equipment  conform  as 

regards  the  provisions  concerning  the  marking  and  to  end  the  infringement  under  the 

conditions  imposed by the Member State. 

Should  non-conformity  persist,  the appropriate  measures  to restrict  or prohibit  the placing 

on the market, transport or use of the equipment in question or to ensure that it is withdrawn 

from  the market  or  from  circulation  shall be taken in accordance  with the procedures  laid 

down in Article  12,2. 

Article 11 

The Annexes to this Directive may be amended in accordance with the procedure laid down 

in Article  12,2. 

22 

Article 12 

1.  The Commission shall be assisted by the Committee on the transport of dangerous goods 
set up by Article 9 of Directive 94/55/EC9, hereinafter  referred  to as  'the Committee'. 

2.  The  representative  of  the  Commission  shall  submit  to  the  committee  a  draft  of  the 

measures to be taken.  The committee shall deliver its opinion on the draft  within a time 

limit  which  the  chairman  may  lay  down  according  to  the  urgency  of  the  matter,  if 

necessary  by taking a vote. 

The opinion shall be recorded in the minutes; in addition, each Member State shall have 

the right  to ask to have its position recorded  in the minutes. 

The  Commission  shall  take  the  utmost  account  of  the  opinion  delevered  by  the 

committee.  It shall  inform  the committee of the manner  in which its opinion has been 

taken into account. 

Article 13 

1.  The  Member  States  shall  adopt  and  publish  the  laws,  regulations  and  administrative 

provisions  necessary  for them to comply with this Directive before  30 June  1998.  They 

shall  forthwith  inform  the Commission thereof. 

When  the  Member  States  adopt  those  measures  they  shall  include  references  to  this 

Directive  or  shall  accompany  them  with  such  references  on  their  official  publication. 

The Member  States shall lay down the manner  in which such references  shall be made. 

Member  States shall apply these provisions  from  1 January  1999. 

9 

O JL  319/7,  12.12.1994 

23 

2.  The Member  States shall communicate to the Commission the texts of the provisions of 

national law which they adopt in the field governed  by this Directive. 

3.  Member  States  shall  lay  down  the  system  of  penalties  for  breaching  the  national 

provisions  adopted pursuant to this Directive and shall take all the measures  necessary 

to  ensure  that  those  penalties  are  applied.  The  penalties  thus  provided  for  shall  be 

effective,  proportionate  and  dissuasive.  Member  States  shall  notify  the  relevant 

provisions  to  the  Commission  not  later  than  30  June  1998  and  shall  notify  any 

subsequent  changes  as soon as possible. 

Article 14 

This  Directive  shall  enter  into force  on the twentieth  day  of  its publication  in the  Official 

Journal  of the European  Communities. 

Article 15 

This  Directive is addressed  to the Member States. 

24 

ANNEX I 

MINIMUM  CRITERIA  TO BE MET BY DESIGNATED INSPECTION  BODIES  OF 
TYPES A (NOTIFIED  BODIES), B OR  C REFERRED TO IN ARTICLES  5,  6 & 7 

1.  A notified body/inspection body that is part of an organization involved in functions other 

than inspection  shall be identifiable  within that organization. 

2.  The inspection body and its staff  shall not engage in any activities that may conflict with 
their  independence  of judgement  and  integrity  in relation  to their  inspection  activities. 
In particular  the personnel  of  the  inspection  body  shall be free  from  any  commercial, 
financial  and  other  pressures  which  might  affect  their  judgement,  particularly  from 
persons or organizations external to the inspection body with an interest in the results of 
inspections  carried  out.  The  impartiality  of the inspection personnel  of the body  must 
be guaranteed. 

3.  The  inspection  body  shall  have  at its disposal  the necessary  personnel  and possess  the 
necessary facilities to enable it to perform properly the technical and administrative tasks 
connected with the inspection and verification operations.  It must also have access to the 
equipment required  to perform  special  verifications. 

4.  The staff  responsible for inspection shall have appropriate qualifications,  sound technical 
and  vocational  training  and  a  satisfactory  knowledge  of  the  requirements  of  the 
inspections  to be carried  out  and  adequate experience  of  such  operations.  In  order  to 
guarantee  a high  level  of  safety  the  inspection  body  must  be  in a position  to provide 
expertise  in the field  of safety  of transportable  pressure equipment.  The staff  shall have 
the ability  to make professional  judgements  as to conformity  with general  requirements 
using examination results and to report thereon. They shall also have the ability required 
to draw up the certificates,  records  and reports to demonstrate that the inspections  have 
been carried  out. 

5.  They  shall  also have relevant  knowledge of the technology  used  for  the  manufacturing 
of the transportable pressure equipment, including accessories, which they inspect, of the 
way  in which  the equipment  submitted  to their  inspections  is used  or  is  intended  to be 
used,  and of the defects  which may occur during use or  in service. 

6.  The  inspection body  and  its personnel  shall carry  out the assessments  and  verifications 
with the highest degree of professional integrity and te  inical competence. The inspection 
body  shall ensure  confidentiality  of  information  obtained in the course  of  its inspection 
activities.  Proprietary  rights  shall be protected. 

7.  The remuneration of persons engaged in inspection activities shall not directly depend on 
the number of inspections  carried  out and in no case on the results of such inspections. 

25 

8.  The inspection body shall have adequate liability insurance unless its liability is assumed 
by the State  in accordance  with national laws or by the organization of  which it  forms 
a part. 

9.  The  inspection  body shall  itself  normally  perform  the inspections  which it contracts  to 
undertake.  When an inspection body  sub-contracts  any part  of  the  inspection,  it shall 
ensure  and be  able to demonstrate  that  its sub-contractor  is competent  to perform  the 
service  in question and shall take full  responsibility  for  that sub-contracting. 

26 

ANNEX II 

CRITERIA SUPPLEMENTARY  TO ANNEX I TO BE MET BY NOTIFIED 
BODIES (DESIGNATED INSPECTION BODIES OF TYPE A) REFERRED TO IN 
ARTICLE 5 

1.  A notified  body  (Type A inspection body) shall be independent  of the parties  involved 

and shall therefore  provide  "third party"  inspection services. 

The  notified  body/inspection  body,  and  its  staff  responsible  for  carrying  out  the 
inspection  shall not be the designer,  manufacturer,  supplier,  purchaser,  owner,  user or 
maintainer  of  the  transportable  pressure  equipment, including  accessories,  which  that 
body  inspects,  nor the authorised  representative  of any of these parties.  They  must not 
be  directly  involved  in  the  design,  construction,  marketing  or  maintenance  of  the 
transportable pressure equipment, including accessories, nor represent the parties engaged 
in  these  activities.  This  does  not  preclude  the  possibility  of  exchanges  of  technical 
information  between  the  manufacturer  of  transportable  pressure  equipment  and  the 
inspection body. 

2.  All interested parties shall have access to the services of the inspection body.  There shall 
not  be  undue  financial  or  other  conditions.  The  procedures  under  which  the  body 
operates  shall be administered  in a non-discriminatory  manner. 

27 

ANNEX III 

CRITERIA  SUPPLEMENTARY  TO ANNEX I TO BE MET BY DESIGNATED 
INSPECTION  BODIES OF TYPE B REFERRED  TO IN ARTICLE  6 

1.  The body shall  form  a separate  and identifiable  part  of an organisation  involved  in the 
design,  manufacture,  supply, use or maintenance of the items it inspects  and shall have 
been established  to supply  inspection services  to its parent organisation. 

. 

2.  The  inspection  body  shall  not  become  directly  involved  in  the  design,  manufacture, 
supply, use of the transportable  pressure equipment,  including accessories  inspected,  or 
similar  competitive items. 

3.  There shall be a clear separation of the responsibilities  of the inspection personnel  from 
those  of  the personnel  employed  in the other  functions,  which  shall  be  established  by 
organisational  identification  and the reporting methods of the inspection body within the 
parent  organisation. 

4.  Inspection services shall only be supplied to the organisation of which the inspection body 

forms  a part  and the clients to whom they  supply gas. 

28 

ANNEX  IV 

CRITERIA  SUPPLEMENTARY  TO  ANNEX  I TO BE MET  BY  DESIGNATED 
INSPECTION  BODIES  OF TYPE  C REFERRED  TO  IN  ARTICLE  7 

There shall be a clear separation of the responsibilities  of the inspection personnel from those 
of the personnel employed in the other functions,  which shall be established by organisational 
identification and the reporting methods of the inspection body within the parent organisation. 

29 

ANNEX V 

PARTI 
CONFORMITY  ASSESSMENT PROCEDURES 

Module A (internal production control) 

1.  This  module  describes  the  procedure  whereby  the  manufacturer  or  his  authorized 
representative  established  within  the  Community  who  carries  out  the  obligations  laid 
down in section 2 ensures and declares that transportable pressure equipment satisfies the 
requirements  of  the  Directive  which apply  to  it.  The manufacturer,  or  his  authorized 
representative  established  within  the  Community,  must  affix  the  n  marking  to  all 
transportable  pressure  equipment  and draw up a written declaration of  conformity. 

2.  The manufacturer  must draw up the technical documentation described  in section  3 and 
either the manufacturer  or his authorized representative established within the Community 
must keep it at the disposal  of the relevant national authorities  for  inspection  purposes 
for  a period  of ten years  after  the last of the transportable  pressure  equipment has been 
manufactured. 

Where neither the manufacturer  nor his authorized representative is established within the 
Community,  the  obligation  to  keep  the  technical  documentation  available  is  the 
responsibility  of  the  person  who  places  the  transportable  pressure  equipment  on  the 
Community  market. 

3.  The technical documentation must enable an assessment to be made of the conformity  of 
the transportable pressure  equipment with the requirements of the Directive which apply 
. to it.  It must,  as far  as is relevant for  such assessment,  cover the design,  manufacture 

and operation  of the transportable  pressure  equipment and contain: 

-  a general  description  of the transportable  pressure  equipment; 

-  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components, 

sub-assemblies,  circuits,  etc.; 

-  descriptions and explanations necessary for an understanding of the said drawings and 

diagrams  and the operation  of the transportable  pressure  equipment; 

-  a description  of the solutions  adopted to meet the requirements  of the Directive; 

- 

- 

results  of the design calculations,  examinations  carried  out, etc.; 

test reports. 

30 

4.  The manufacturer,  or his authorized  representative  established  within the Community, 
must keep a copy of the declaration of conformity  with the technical  documentation. 

5.  The  manufacturer  must  take  all  measures  necessary  to  ensure  that  the  manufacturing 
process requires  the manufactured  transportable  pressure  equipment to comply with the 
technical  documentation  referred  to  in  section 2  and  with  the  requirements  of  the 
Directive which apply to it. 

Module Al  (internal manufacturing checks with monitoring of the final  assessment) 

In addition to the requirements  of module A,  the following applies. 

Final  assessment  must  be  pierformed  by  the  manufacturer  and  monitored  by  means  of 
unexpected visits by a notified  body  (type A inspection body) chosen by the  manufacturer. 

During  such visits,  the notified  body must: 

- 

- 

ensure that the manufacturer  actually performs  final  assessment; 

take  samples  of  transportable  pressure  equipment  at  the  manufacturing  or  storage 
premises in order to conduct checks.  The notified body assesses  the number of items of 
equipment to sample and whether  it is necessary  to perform,  or have performed,  all or 
part of the final  assessment  of the transportable  pressure  equipment samples. 

Should  one  or  more  of  the  items  of  transportable  pressure  equipment  not  conform,  the 
notified  body must take appropriate measures. 

On  the  responsibility  of  the  notified  body,  the  manufacturer  must  affix  the  former's 
identification  number on each item of transportable  pressure  equipment. 

Module B (EC type-examination) 

1.  This  module  describes  the  part  of  the  procedure  by  which  a  notified  body  (type  A 
inspection  body)  ascertains  and  attests  that a representative  example  of  the  production 
envisaged  meets the provisions  of the Directive  which apply to it. 

2.  The application for  EC type-examination must be lodged by the manufacturer  or by his 
authorized  representative  established  within the Community with a single notified  body 
of his choice. 

31 

The application must include: 

- 

the name  and  address  of  the manufacturer  and,  if  the  application  is  lodged  by  the 
authorized  representative,  his name and address  as well; 

-  a written  declaration  that  the  same application  has  not  been lodged  with  any  other 

notified  body; 

- 

the technical documentation described  in section 3. 

The applicant must place at the disposal of the notified body a representative  example of 
the  production  envisaged,  hereinafter  called  "type".  The  notified  body  may  request 
further  examples  should  the test programme  so require. 

A type may cover several versions of transportable pressure equipment provided that the 
differences  between the versions  do not affect  the level of  safety. 

3.  The technical documentation must enable an assessment  to be made of the conformity  of 
the transportable pressure equipment with the requirements of the Directive which apply 
to it.  It must,  as far  as is relevant for  such assessment,  cover the design,  manufacture 
and operation  of the transportable  pressure  equipment  and contain: 

-  a general  description  of the type; 

-  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components, 

sub-assemblies,  circuits,  etc.; 

-  descriptions and explanations necessary for an understanding of the said drawings and 

diagrams  and the operation of the transportable  pressure  equipment; 

-  a  description  of  the  solutions  adopted  to  meet  the  essential  requirements  of  the 

Directive; 

- 

- 

- 

- 

results  of design calculations made, examinations  carried  out, etc.; 

test reports; 

information  concerning  the tests provided  for  in manufacture; 

information  concerning  the qualifications  or approvals. 

4.  The notified  body must: 

4.1. 

examine the technical documentation,  verify  that the type has been manufactured  in 
conformity  with  it  and  identify  the  components  designed  in  accordance  with  the 
relevant  provisions  of the Directive. 

32 

In particular, the notified body must examine the technical documentation with respect 
to the design and the manufacturing  procedures; 

perform  or  have  performed  the  appropriate  examinations  and  necessary  tests  to 
establish whether the solutions adopted by the manufacturer meet the requirements of 
the Directive; 

perform  or  have  performed  the  appropriate  examinations  and  necessary  tests  to 
establish  whether the relevant provisions  of the Directive have been applied; 

agree with the applicant the location where the examinations and necessary  tests are 
to be carried  out. 

4.2. 

4.3. 

4.4. 

5.  Where  the type  satisfies  the provisions  of the Directive  which apply  to  it,  the  notified 
body  must  issue  an EC  type-examination  certificate  to  the applicant.  The  certificate, 
which should be valid for ten years and be renewable, must contain the name and address 
of  the  manufacturer,  the  conclusions  of  the  examination  and  the  necessary  data  for 
identification  of the approved type. 

A  list  of  the  relevant  parts  of  the  technical  documentation  must  be  annexed  to  the 
certificate  and a copy kept by the notified  body. 

If  the  notified  body  refuses  to  issue  an  EC  type-examination  certificate  to  the 
manufacturer  or to his authorized representative  established  within the Community, that 
body  must  provide  detailed  reasons  for  such  refusal.  Provision  must  be  made  for  an 
appeals procedure. 

6.  The  applicant  must  inform  the  notified  body  that  holds  the  technical  documentation 
concerning  the  EC  type-examination  certificate  of  all  modifications  to  the  approved 
transportable pressure equipment; these are subject to additional approval where they may 
affect conformity  with the  requirements of the Directive or the prescribed conditions for 
use of the transportable  pressure  equipment.  This additional approval must be given in 
the form  of an addition to the original  EC type-examination  certificate. 

7.  Each  notified  body  must  communicate  to the  Member  States  the  relevant  information 
concerning  EC  type-examination  certificates  which  it has withdrawn,  and,  on  request, 
those it has  issued. 

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant 
information concerning the EC type-examination certificates  it has withdrawn or  refused. 

8.  The  other  notified  bodies  may  receive  copies  of  the  EC  type-examination  certificates 
and/or their additions.  The annexes to the certificates  must be held at the disposal of the 
other notified  bodies. 

33 

9.  The manufacturer,  or  his authorized  representative  established  within the Community, 
must keep with the technical documentation copies of EC type-examination  certificates 
and their  additions  for  a period of ten years  after  the last of the transportable  pressure 
equipment has been  manufactured. 

Where neither the manufacturer nor his authorized representative is established within the 
Community,  the  obligation  to  keep  the  technical  documentation  available  is  the 
responsibility  of the person who places the product on the Community  market. 

Module Bl  (EC design-examination) 

1.  This  module  describes  the  part  of  the  procedure  whereby  a  notified  body  (type  A 
inspection body) ascertains and attests that the design of an item of transportable pressure 
equipment meets the provisions  of the Directive  which apply to it. 

2.  The manufacturer,  or his  authorized  representative  established  within the  Community, 
must lodge an application for  EC design examination with a single notified  body. 

The application must include: 

- 

the  name  and  address  of  the manufacturer  and,  if  the  application  is  lodged  by  the 
authorized  representative,  his name and address  as well; 

-  a written  declaration  that  the same  application has  not been  lodged  with  any  other 

notified  body; 

- 

the technical documentation described  in section  3. 

The  application  may  cover  several  versions  of  the  transportable  pressure  equipment 
provided  that the differences  between the versions  do not affect  the level of  safety. 

3.  The technical documentation must enable an assessment  to be made of the conformity  of 
the transportable pressure equipment with the requirements of the Directive which apply 
to it.  It must,  as far  as is relevant for  such assessment,  cover the design,  manufacture 
and operation  of the transportable  pressure  equipment and contain : 

-  a general description  of the transportable  pressure  equipment; 

-  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components, 

sub-assemblies,  circuits,  etc.; 

-  descriptions and explanations necessary for an understanding of the said drawings and 

diagrams  and the operation of the transportable  pressure  equipment; 

34 

-  a description  of the solutions  adopted to meet the requirements  of the Directive; 

- 

the  necessary  supporting  evidence  for  the  adequacy  of  the  design  solution;  this 
supporting  evidence must  include the results  of tests  carried  out by the appropriate 
laboratory  of the manufacturer  or on his behalf; 

- 

results  of design calculations made, examinations  carried  out, etc. 

4.  The notified  body must: 

4.1. 

examine the technical documentation  and identify  the components  which have been 
designed  in accordance  with the relevant provisions  of the Directive. 

In particular,  the notified  body must: 

- 

assess the materials where these are not in conformity  with the relevant provisions 
of the Directive; 

- 

approve  the procedures  for joining the pressure  equipment parts; 

-  verify  that the personnel undertaking the joining of pressure equipment parts and 

the non-destructive  tests  are qualified  or approved; 

4.2. 

4.3. 

perform  the necessary examinations to establish whether the solutions adopted by the 
manufacturer  meet the requirements  of the Directive; 

perform the necessary examinations to establish whether the relevant provisions of the 
Directive  have been applied. 

5.  Where  the design  meets  the provisions  of the  Directive  which apply  to  it,  the  notified 
body  must  issue  an EC design-examination  certificate  to the applicant.  The  certificate 
must contain the name and address of the applicant,  the conclusions  of the examination, 
conditions for its validity and the necessary data for identification of the approved design. 

A  list  of  the  relevant  parts  of  the  technical  documentation  must  be  annexed  to  the 
certificate  and a copy kept by the notified  body. 

If  the  notified  body  refuses  to  issue  an  EC  design-examination  certificate  to  the 
manufacturer  or to his authorized representative  established within the Community, that 
body  must  provide  detailed  reasons  for  such  refusal.  Provision  must  be made  for  an 
appeals procedure. 

35 

6.  The  applicant  must  inform  the  notified  body  that  holds  the  technical  documentation 
concerning  the  EC design-examination  certificate  of  all modifications  to  the  approved 
design;  these  are  subject  to  additional  approval  where  such  changes  may  affect  the 
conformity of the transportable pressure equipment with the requirements of the Directive 
or the prescribed  conditions for use of the equipment.  This additional approval must be 
given in the form  of an addition to the original  EC design-examination  certificate. 

7.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information 
concerning EC design-examination certificates  which it has withdrawn, and, on request, 
those  it has issued. 

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant 
information  concerning  the  EC design-examination  certificates  it  has  withdrawn  or 
refused. 

8.  The other notified  bodies may on request  obtain the relevant  information  concerning: 

- 

- 

the EC design-examination  certificates  and additions granted; 

the EC design-examination  certificates  and additions  withdrawn. 

9.  The manufacturer,  or  his  authorized  representative  established  within the  Community, 
must  keep  with  the  technical  documentation  referred 
to  in  section 3  copies  of 
EC design-examination certificates  and their additions for a period of ten years after  the 
last of the transportable  pressure  equipment has been  manufactured. 

Where neither the manufacturer  nor his authorized representative is established within the 
Community,  the  obligation  to  keep  the  technical  documentation  available  is  the 
responsibility  of the person  who places the product on the Community  market. 

Module CI  (conformity  to type) 

1.  This  module  describes  that  part  of  the  procedure  whereby  the  manufacturer,  or  his 
authorized  representative  established  within the Community,  ensures  and  declares  that 
transportable  pressure  equipment  is  in  conformity  with  the  type  as  described  in  the 
EC type-examination  certificate  and  satisfies  the  requirements  of  the  Directive  which 
apply  to  it.  The  manufacturer,  or  his  authorized  representative  established  within the 
Community,  must affix  the n  marking to all transportable pressure  equipment and draw 
up a written declaration  of  conformity. 

2.  The  manufacturer  must  take  all  measures  necessary  to  ensure  that  the  manufacturing 
process  requires  the manufactured  transportable  pressure  equipment to comply  with the 
type as described  in the EC type-examination certificate  and with the requirements of the 
Directive  which apply to it. 

36 

The manufacturer,  or  his authorized  representative  established  within the Community, 
must keep a copy of the declaration of conformity  for a period of ten years after  the last 
of the transportable  pressure  equipment has been  manufactured. 

Where neither the manufacturer nor his authorized representative is established within the 
Community,  the  obligation  to  keep  the  technical  documentation  available  is  the 
responsibility  of  the  person  who  places  the  transportable  pressure  equipment  on  the 
Community  market. 

Final  assessment  must be subject  to monitoring  in the form  of  unexpected  visits  by a 
notified  body  (type A inspection body) chosen by the  manufacturer. 

During  such visits,  the notified  body must: 

-  ensure that the manufacturer  actually performs final assessment; 

- 

take  samples  of  transportable  pressure  equipment  at  the  manufacturing  or  storage 
premises  in order  to conduct checks.  The notified  body must assess  the number of 
items  of  equipment  to  sample  and  whether  it  is  necessary  to  perform,  or  have 
performed,  all or  part  of final assessment  on the transportable  pressure  equipment 
samples. 

Should one or more of the items of transportable  pressure  equipment not conform,  the 
notified  body must take appropriate measures. 

On  the  responsibility  of  the  notified  body,  the  manufacturer  must  affix  the  former's 
identification  number on each item of transportable  pressure  equipment. 

Module D (production  quality assurance) 

1.  This  module  describes  the  procedure  whereby  the  manufacturer  who  satisfies  the 
obligations  of  section 2 ensures  and declares  that the transportable  pressure  equipment 
concerned is in conformity  with the type described in the EC type-examination certificate 
and satisfies  the requirements  of the Directive which apply to it.  The manufacturer,  or 
his authorized representative established within the Community, must affix the n marking 
to all transportable pressure equipment and draw up a written declaration of  conformity. 
The n  marking  must be accompanied by the identification  number  of the notified  body 
(type  A  inspection  body)  responsible  for  Community  surveillance  as  specified  in 
section 4. 

2.  The  manufacturer  must  operate  an  approved  quality  system  for  production,  final 
inspection and testing as specified  in section 3 and be subject to surveillance as specified 
in section 4. 

37 

3.  Quality  system 

3.1.  The manufacmrer  must lodge an application for assessment of his quality system with 

a notified  body of his choice. 

The application must include: 

- 

- 

- 

all relevant  information  on the transportable  pressure  equipment  concerned; 

the documentation concerning  the quality system; 

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

3.2.  The quality  system must ensure compliance of the transportable  pressure  equipment 
with  the  type  described  in  the  EC  type-examination  certificate  and  with  the 
requirements  of the Directive  which apply to it. 

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

It must contain in particular  an adequate description  of: 

- 

- 

- 

- 

- 

the quality objectives and the organizational structure, responsibilities and powers 
of  the  management  with  regard  to  the  quality  of  the  transportable  pressure 
equipment; 

the manufacturing, quality control and quality assurance techniques, processes and 
systematic  measures  that will be used,  particularly  the procedures  used; 

the  examinations  and  tests  that  will  be  carried  out  before,  during  and  after 
manufacture,  and the frequency  with which they will be carried  out; 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  or approvals  of the personnel  concerned; 

the means of monitoring the achievement of the required quality and the  effective 
operation of the quality  system. 

3.3.  The notified  body must assess the quality system to determine whether it satisfies  the 

requirements  referred  to in 3.2. 

The  auditing  team must have at least  one member  with experience  of  assessing  the 
transportable pressure equipment concerned.  The assessment procedure must include 
an inspection  visit to the manufacturer's  premises. 

38 

The decision must be notified  to the manufacturer.  The notification must contain the 
conclusions of the examination and the reasoned assessment decision.  Provision must 
be made for  an appeals procedure. 

3.4.  The manufacturer  must undertake  to fulfil  the obligations  arising  out of the quality 
system  as approved  and to ensure that it remains  satisfactory  and  efficient. 

The manufacmrer,  or his authorized representative established within the Community, 
must  inform  the notified  body that has approved the quality  system  of any intended 
adjustment  to the quality  system. 

The notified body must assess the proposed changes and decide whether the amended 
quality  system  will  still  satisfy  the  requirements  referred  to  in 3.2  or  whether  a 
reassessment  is required. 

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

4.  Surveillance under  the responsibility  of the notified  body 

4.1.  The  purpose  of  surveillance  is  to make  sure  that  the manufacmrer  duly  fulfils  the 

obligations  arising  out of the approved  quality system. 

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

- 

- 

the quality  system  documentation; 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  of-the personnel  concerned,  etc. 

4.3.  The notified  body must carry  out periodic audits to make sure that the manufacmrer 
maintains and applies the quality system and provide the manufacturer  with an audit 
report.  The  frequency  of  periodic  audits  must  be  such  that  a full  reassessment  is 
carried  out every  three years. 

4.4. 

In addition  the  notified  body  may pay unexpected  visits  to the manufacmrer.  The 
need for  such additional visits,  and the frequency  thereof,  will be determined  on the 
basis  of  a  visit  control  system  operated  by  the  notified  body.  In  particular,  the 
following  factors  must be considered  in the visit control system: 

- 

- 

- 

the category  of the equipment; 

the results  of previous  surveillance visits; 

the need  to follow  up corrective  action; 

39 

- 

- 

special conditions linked to the approval of the system,  where applicable; 

significant  changes in manufacturing  organization,  policy  or techniques. 

During such visits the notified body may carry out or have carried out tests to verify 
if necessary  that the quality system is functioning  correctly.  The notified body must 
provide the manufacmrer  with a visit report and, if a test has taken place, with a test 
report. 

5.  The  manufacmrer  must,  for  a  period  of  ten  years  after  the  last  of  the  transportable 
pressure  equipment  has  been  manufactured,  hold  at  the  disposal  of  the  national 
authorities: 

- 

- 

- 

the documentation referred  to in the second  indent of 3.1; 

the adjustments  referred  to in the second paragraph  of 3.4; 

the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last 
paragraph  of  3.3, the last paragraph  of 3.4,  and in 4.3  and 4.4. 

6.  Each  notified  body  must  communicate  to the  Member  States  the  relevant  information 
concerning  the quality system approvals which it has withdrawn,  and, on request,  those 
it has issued. 

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant 
information  concerning  the quality  system  approvals  it has withdrawn or  refused. 

Module Dl  (production  quality assurance) 

1.  This  module  describes  the  procedure  whereby  the  manufacturer  who  satisfies  the 
obligations  of  section  3 ensures  and  declares  that  the  items  of  transportable  pressure 
equipment concerned satisfy  the requirements of the Directive which apply to them.  The 
manufacturer,  or his authorized  representative  established  within the Community,  must 
affix  the  II  marking  to  each  item  of  transportable  pressure  equipment  and  draw  up a 
written  declaration  of  conformity.  The  II  marking  must  be  accompanied  by  the 
identification  number  of  the  notified  body  (type  A  inspection  body)  responsible  for 
Community  surveillance  as specified  in section 5. 

2.  The manufacmrer  must draw up the technical documentation described  below. 

The technical documentation must enable an assessment  to be made of the conformity  of 
the transportable pressure equipment with the requirements of the Directive which apply 
to it.  It must,  as far  as is relevant for  such assessment,  cover the design,  manufacture 
and operation  of the transportable  pressure  equipment  and contain: 

40 

-  a general  description  of the transportable  pressure  equipment; 

-  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components, 

sub-assemblies,  circuits, etc.; 

-  descriptions and explanations necessary for an understanding of the said drawings and 

diagrams  and the operation of the transportable  pressure  equipment; 

-  a description  of the solutions  adopted to meet the requirements  of the Directive; 

- 

- 

results  of design calculations made, examinations carried  out, etc.; 

test reports. 

3.  The  manufacmrer  must  operate  an  approved  quality  system  for  production,  final 
inspection and testing as specified  in section 4 and be subject to surveillance as specified 
in section 5. 

4.  Quality system 

4.1.  The manufacmrer must lodge an application for assessment of his quality system with 

a notified  body of his choice. 

The application must include: 

- 

- 

all relevant  information  on the transportable  pressure  equipment  concerned; 

the documentation concerning the quality  system. 

4.2.  The quality  system must ensure compliance of the transportable  pressure  equipment 

with the requirements of the Directive which apply to it. 

All the elements,  requirements  and provisions  adopted by the manufacmrer  must be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  The  quality  system  documentation  must  permit  a 
consistent  interpretation  of the quality programmes,  plans, manuals  and records. 

It must contain in particular  an adequate description  of: 

- 

- 

the quality objectives and the organizational structure, responsibilities and powers 
of  the  management  with  regard  to  the  quality  of  the  transportable  pressure 
equipment; 

the manufacturing, quality control and quality assurance techniques, processes and 
systematic  measures  that will be used; 

41 

- 

- 

- 

the  examinations  and  tests  that  will  be  carried  out  before,  during  and  after 
manufacture,  and the frequency  with which they will be carried  out; 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  or approvals  of the personnel  concerned; 

the means of monitoring the achievement of the required quality and the  effective 
operation of the quality  system. 

4.3.  The notified body must assess the quality system to determine whether it satisfies  the 

requirements  referred  to in 4.2. 

The auditing  team must have at least one member  with experience  of  assessing  the 
transportable pressure equipment concerned.  The assessment procedure must include 
an inspection  visit to the manufacturer's  premises. 

The decision must be notified  to the manufacmrer.  The notification must contain the 
conclusions of the examination and the reasoned assessment decision.  Provision must 
be made for  an appeals procedure. 

4.4.  The manufacmrer  must undertake  to fulfil  the obligations  arising  out of the quality 
system  as approved  and to ensure that it remains  satisfactory  and  efficient. 

The manufacturer,  or his authorized representative established within the Community, 
must inform  the notified  body that has approved  the quality system of any intended 
adjustment  to the quality  system. 

The notified body must assess the proposed changes and decide whether the amended 
quality  system  will  still  satisfy  the  requirements  referred  to  in  4.2  or  whether  a 
reassessment  is required. 

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

5.  Surveillance  under  the responsibility  of the notified  body 

5.1.  The  purpose  of  surveillance  is  to make  sure  that  the manufacmrer  duly  fulfils  the 

obligations  arising  out of the approved  quality system. 

5.2.  The manufacmrer  must allow the notified  body access for  inspection purposes to the 
locations  of  manufacture,  inspection,  testing  and  storage  and  provide  it  with  all 
necessary  information,  in particular: 

- 

- 

the quality  system  documentation; 

the quality records,  such as inspection reports and test data, calibration data, reports 
concerning  the qualifications  of the personnel  concerned etc. 

42 

5.3.  The notified  body must carry  out periodic audits to make sure that the manufacturer 
maintains and applies the quality system and provide the manufacmrer  with an audit 
report.  The  frequency  of  periodic  audits  must  be  such  that  a full  reassessment  is 
carried  out every  three years. 

5.4. 

In addition the  notified  body  may pay unexpected  visits  to the  manufacmrer.  The 
need for  such additional visits, and the frequency  thereof, will be determined  on the 
basis  of  a  visit  control  system  operated  by  the  notified  body.  In  particular,  the 
following  factors  must be considered  in the visit control system: 

- 

- 

- 

- 

- 

the category  of the equipment; 

the results  of previous  surveillance visits; 

the need to follow  up corrective  action; 

special conditions  linked to the approval  of the system,  where applicable; 

significant  changes  in manufacturing  organization,  policy or techniques. 

During such visits the notified  body may carry out or have carried out tests to verify 
if necessary  that the quality system is functioning  correctly.  The notified  body must 
provide the manufacturer  with a visit report and, if a test has taken place, with a test 
report. 

6.  The  manufacmrer  must,  for  a  period  of  ten  years  after  the  last  of  the  transportable 
pressure  equipment  has  been  manufactured,  hold  at  the  disposal  of  the  national 
authorities: 

- 

- 

- 

- 

the technical documentation referred  to in section 2; 

the documentation  referred  to in the second  indent of  4.1; 

the adjustments  referred  to in the second paragraph  of 4.4; 

the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last 
paragraph  of 4.3,  the last paragraph  of 4.4,  and in 5.3  and 5.4. 

7.  Each  notified  body  must  communicate  to the  Member  States  the  relevant  information 
concerning the quality system approvals which it has withdrawn,  and,  on request,  those 
it has  issued. 

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant 
information  concerning  the quality  system approvals  it has withdrawn  or  refused. 

43 

Module E (product quality assurance) 

1.  This  module  describes  the  procedure  whereby  the  manufacmrer  who  satisfies  the 
obligations  of  section 2 ensures  and declares that the transportable  pressure  equipment 
is  in conformity  with the type as described  in the EC type-examination  certificate  and 
satisfies  the requirements  of the Directive which apply to it.  The manufacmrer,  or his 
authorized  representative  established  within the Community,  must affix  the II marking 
to each product and draw up a written declaration of conformity.  The II marking must 
be  accompanied  by  the  identification  number  of  the  notified  body  (type  A  inspection 
body) responsible  for  surveillance  as specified  in section 4. 

2.  The manufacturer  must  operate  an approved  quality  system  for  the  final  transportable 
pressure  equipment  inspection  and  testing  as  specified  in  section  3  and  be  subject  to 
surveillance  as specified  in section 4. 

3.  Quality system 

3.1.  The manufacmrer  must lodge an application for assessment  of his quality system  for 

the transportable  pressure  equipment with a notified  body of his choice. 

The application must include: 

- 

- 

- 

all relevant  information  on the transportable  pressure  equipment  concerned; 

the documentation concerning  the quality  system; 

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

3.2.  Under  the  quality  system,  each  item  of  transportable  pressure  equipment  must  be 
examined and appropriate  tests must be carried out in order to ensure  its  conformity 
with  the  requirements  of  the  Directive  which  apply  to  it.  All  the  elements, 
requirements  and provisions  adopted by the manufacturer  must be documented  in a 
systematic  and  orderly  manner  in  the  form  of  written  policies,  procedures  and 
This  quality  system  documentation  must  permit  a  consistent 
instructions. 
interpretation  of the quality programmes,  plans, manuals  and records. 

It must contain in particular  an adequate description  of: 

- 

- 

- 

the quality objectives and the organizational structure, responsibilities and powers 
of  the  management  with  regard  to  the  quality  of  the  transportable  pressure 
equipment; 

the examinations  and tests  to be carried  out after  manufacture; 

the means of monitoring  the effective  operation of the quality  system; 

44 

- 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  or approvals  of the personnel  concerned. 

3.3.  The notified body must assess the quality system to determine whether it satisfies  the 

requirements  referred  to in 3.2. 

The auditing  team must have at least one member  with experience  of  assessing  the 
transportable pressure equipment concerned.  The assessment procedure must include 
an inspection visit to the manufacturer's  premises. 

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

3.4.  The manufacmrer  must undertake to discharge the obligations arising from the quality 
system  as approved  and to ensure that it remains  satisfactory  and  efficient. 

The manufacmrer,  or his authorized representative established within the Community, 
must inform the notified body which has approved the quality system of any intended 
adjustment  to the quality  system. 

The notified body must assess the proposed changes and decide whether the modified 
quality  system  will  still  satisfy  the  requirements  referred  to  in  3.2  or  whether  a 
reassessment  is required. 

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

4.  Surveillance under the responsibility  of the notified  body 

4.1.  The  purpose  of  surveillance  is  to make  sure  that  the  manufacmrer  duly  fulfils  the 

obligations  arising  out of the approved  quality  system. 

4.2.  The manufacmrer  must allow the notified body access for  inspection purposes  to the 
locations  of  inspection,  testing  and  storage  and  provide  it  with  all  necessary 
information,  in particular: 

- 

the quality  system  documentation; 

- 

- 

the technical  documentation; 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  of the personnel  concerned,  etc. 

4.3.  The notified  body must carry  out periodic audits to make sure that the manufacmrer 
maintains and applies the quality system and provide the manufacturer  with an audit 
report.  The  frequency  of  periodic  audits  must  be  such  that  a full  reassessment  is 
carried  out every  three years. 

45 

4.4. 

In  addition  the  notified  body  may pay unexpected  visits  to the manufacturer.  The 
need for  such additional visits, and the frequency  thereof,  will be determined on the 
basis  of  a  visit  control  system  operated  by  the  notified  body.  In  particular,  the 
following  factors  must be considered  in the visit control system: 

- 

- 

- 

- 

- 

the category  of the equipment; 

the results  of previous  surveillance visits; 

the need to follow  up corrective  action; 

special  conditions  linked to the approval  of the system,  where applicable; 

significant  changes in manufacturing  organization,  policy or techniques. 

During such visits, the notified body may carry out or have carried out tests to verify 
if necessary  that the quality system is functioning  correctly.  The notified  body must 
provide the manufacturer  with a visit report and, if a test has taken place, with a test 
report. 

5.  The  manufacmrer  must,  for  a  period  of  ten  years  after  the  last  of  the  transportable 
pressure  equipment  has  been  manufactured,  hold  at  the  disposal  of  the  national 
authorities: 

- 

- 

- 

the documentation referred  to in the second  indent of 3.1; 

the adjustments  referred  to in the second paragraph  of 3.4; 

the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last 
paragraph  of  3.3, the last paragraph  of  3.4,  and in 4.3 and 4.4. 

6.  Each  notified  body  must  communicate  to the Member  States  the  relevant  information 
concerning  the quality  system approvals  which it has withdrawn  and,  on request,  those 
it has  issued. 

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant 
information  concerning  the quality  system approvals  it has withdrawn or  refused. 

46 

Module El  (product quality assurance) 

1.  This  module  describes  the  procedure  whereby  the  manufacmrer  who  satisfies  the 
obligations  of  section  3 ensures  and declares that the transportable  pressure  equipment 
satisfies  the requirements  of the Directive which apply to it.  The manufacturer,  or his 
authorized  representative  established  within the Community,  must  affix  the II  marking 
to each item of transportable  pressure  equipment and draw up a written declaration of 
conformity.  The II  marking  must be accompanied  by the identification  number  of the 
notified body (type A inspection body) responsible for surveillance as specified  in section 
5. 

2.  The manufacmrer  must draw up the technical documentation described  below. 

The technical documentation must enable an assessment to be made of the conformity  of 
the transportable pressure equipment with the requirements of the Directive which apply 
to it.  It must,  as far  as is relevant for  such assessment,  cover the design,  manufacture 
and operation  of the transportable  pressure  equipment and contain: 

-  a general description  of the transportable  pressure  equipment; 

-  conceptual  design  and  manufacturing  drawings  and  diagrams  of  components, 

sub-assemblies,  circuits,  etc.; 

-  descriptions and explanations necessary for an understanding of the said drawings and 

diagrams  and the operation  of the traznsportable  pressure  equipment; 

-  a description  of the solutions  adopted to meet the requirements  of the Directive; 

- 

- 

results  of design calculations made, examinations carried  out, etc.; 

test reports. 

3.  The manufacmrer  must  operate  an approved  quality  system  for  the  final  transportable 
pressure  equipment  inspection  and  testing  as  specified  in  section  4  and  be  subject  to 
surveillance  as specified  in section 5. 

4.  Quality  system 

4.1.  The manufacmrer  must lodge an application for assessment of his quality system with 

a notified  body  of his choice. 

The application must include: 

- 

- 

all relevant  information  on the pressure  equipment concerned; 

the documentation concerning the quality  system. 

47 

4.2.  Under  the  quality  system,  each  item  of  transportable  pressure  equipment  must  be 
examined and appropriate tests must be carried  out in order to ensure its  conformity 
with  the  requirements  of  the  Directive  which  apply  to  it.  All  the  elements, 
requirements  and provisions  adopted by the manufacturer  must be documented  in a 
systematic  and  orderly  manner  in  the  form  of  written  policies,  procedures  and 
instructions. 
This  quality  system  documentation  must  permit  a  consistent 
interpretation  of the quality programmes,  plans, manuals and records. 

It must contain in particular  an adequate description  of: 

- 

- 

- 

- 

- 

the quality objectives and the organizational structure, responsibilities and powers 
of  the  management  with  regard  to  the  quality  of  the  transportable  pressure 
equipment; 

the procedures  used  for  the joining of parts; 

the examinations  and tests to be carried  out after  manufacture; 

the means of monitoring  the effective  operation of the quality  system; 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  or  approvals  of the personnel  concerned. 

4.3.  The notified  body must assess the quality system to determine whether it satisfies  the 

requirements  referred  to in 4.2. 

The auditing  team  must have at least  one member  with experience  of  assessing  the 
transportable pressure equipment concerned.  The assessment procedure must include 
an inspection visit to the manufacmrer's  premises. 

The decision must be notified  to the manufacturer.  The notification  must contain the 
conclusions of the examination and the reasoned assessment decision.  Provision must 
be made for  an appeals procedure. 

4.4.  The manufacmrer  must undertake to discharge the obligations arising from the quality 
system  as approved  and to ensure  that it remains  satisfactory  and  efficient. 

The manufacturer, or his authorized representative established within the Community, 
must inform the notified body which has approved the quality system of any intended 
adjustment  to the quality  system. 

The notified body must assess the proposed changes and decide whether the modified 
quality  system  will  still  satisfy  the  requirements  referred  to  in  4.2  or  whether  a 
reassessment  is required. 

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

48 

5.  Surveillance under  the responsibility  of the notified  body 

5.1.  The  purpose  of  surveillance  is  to make  sure  that  the  manufacmrer  duly  fulfils  the 

obligations  arising  out of the approved  quality  system. 

5.2.  The manufacmrer  must allow the notified  body access for inspection purposes to the 
locations  of  inspection,  testing  and  storage  and  provide  it  with  all  necessary 
information,  in particular: 

- 

- 

- 

the quality  system documentation; 

the technical  documentation; 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  of the personnel  concerned,  etc. 

5.3.  The notified  body must carry out periodic audits to make sure that the manufacmrer 
maintains and applies the quality system and provide the manufacmrer  with an audit 
report.  The  frequency  of  periodic  audits  must  be  such that  a full  reassessment  is 
carried  out every  three years. 

5.4. 

In addition  the notified  body  may pay unexpected  visits  to the manufacmrer.  The 
need for  such additional visits,  and the frequency  thereof,  will be determined  on the 
basis  of  a  visit  control  system  operated  by  the  notified  body. 
In  particular,  the 
following  factors  must be considered  in the visit control  system: 

- 

the category  of the equipment; 

- 

- 

- 

- 

the results  of previous  surveillance visits; 

the need to follow  up corrective  action; 

special  conditions  linked to the approval  of the system,  where  applicable; 

significant  changes  in manufacturing  organization,  policy or techniques. 

During such visits the notified body may carry  out or have carried out tests to verify 
if necessary  that the quality system is functioning  correctly.  The notified  body must 
provide the manufacturer  with a visit report and, if a test has taken place, with a test 
report. 

6.  The  manufacturer  must,  for  a  period  of  ten  years  after  the  last  of  the  transportable 
pressure  equipment  has  been  manufactured,  keep  at  the  disposal  of  the  national 
authorities: 

- 

the technical  documentation referred  to in section 2; 

49 

- 

- 

- 

the documentation  referred  to in the third  indent of  4.1; 

the adjustments  referred  to in the second paragraph  of 4.4; 

the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in the  last 
paragraph  of 4.3,  the last paragraph  of 4.4  and in 5.3  and 5.4. 

7.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information 
concerning the quality  system approvals  which it has withdrawn and,  on request,  those 
it has issued. 

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant 
information  concerning  the quality  system approvals  it has withdrawn  or  refused. 

Module F (product  verification) 

1.  This  module  describes  the  procedure  whereby  a  manufacturer,  or  his  authorized 
representative  established  within  the  Community,  ensures  and  declares  that  the 
transportable  pressure  equipment subject to the provisions  of section  3 is in  conformity 
with the type described 

- 

- 

in the EC type-examination  certificate  or 

in the EC design examination  certificate 

and satisfies  the requirements  of the Directive which apply to it. 

2.  The  manufacmrer  must  take  all  measures  necessary  to  ensure  that  the  manufacmring 
process requires the transportable pressure equipment to comply with the type described 

- 

- 

in the EC type-examination  certificate  or 

in the EC design examination  certificate 

and with the requirements  of the Directive which apply to it. 

The manufacmrer,  or  his  authorized  representative  established  within the  Community, 
must  affix  the  II  marking  to  all  transportable  pressure  equipment  and  draw  up  a 
declaration of  conformity. 

3.  The notified  body  (type A inspection body) must perform  the appropriate  examinations 
and tests  in order  to check the conformity  of the transportable  pressure  equipment with 
the  relevant  requirements  of  the  Directive  by  examining  and  testing  every  product  in 
accordance  with section 4. 

50 

The manufacmrer,  or  his authorized  representative  established  within the Community, 
must keep a copy of the declaration of conformity  for  a period of ten years after  the last 
of the transportable  pressure  equipment has been  manufactured. 

4.  Verification by examination and testing of each item of transportable pressure equipment 

4.1.  Each  item of  transportable  pressure  equipment  must  be  individually  examined  and 
must undergo appropriate  examinations and tests  in order  to verify  that it conforms 
to the type and the requirements  of the Directive  which apply  toit. 

4.2.  The notified  body must affix  its identification  number or have it affixed  to each item 
of transportable  pressure  equipment and draw up a written certificate  of  conformity 
relating  to the tests carried  out. 

4.3.  The manufacmrer,  or his authorized representative established within the Community, 
must  ensure  that  the  certificates  of  conformity  issued  by  the  notified  body  can be 
made available on request. 

Module G (EC unit  verification) 

1.  This module describes the procedure whereby the manufacturer  ensures and declares that 
transportable  pressure  equipment  which has been issued  with the certificate  referred  to 
in  section 4.1  satisfies  the  requirements  of  the  Directive  which  apply  to  it.  The 
manufacmrer  must affix  the II marking to the transportable pressure equipment and draw 
up a declaration  of  conformity. 

2.  The manufacmrer  must apply to a notified  body  (type A inspection body) of his choice 

for  unit  verification. 

The application must contain: 

- 

the  name  and  address  of  the  manufacturer  and  the  location  of  the  transportable 
pressure  equipment; 

-  a written declaration to the effect  that a similar application has not been lodged with 

another notified  body; 

- 

technical  documentation. 

3.  The  technical documentation  must  enable the conformity  of  the  transportable  pressure 
equipment with the requirements of the Directive which apply to it to be assessed  and the 
design,  manufacture  and  operation  of  the  transportable  pressure  equipment  to  be 
understood. 

51 

The technical documentation must contain: 

-  a general description  of the transportable  pressure  equipment; 

-  conceptual  design  and  manufacmring  drawings  and  diagrams  of  components,  sub 

assemblies,  circuits,  etc.; 

-  descriptions and explanations necessary for an understanding of the said drawings and 

diagrams  and the operation of the transportable  pressure  equipment; 

- 

- 

results  of design calculations made, examinations  carried  out, etc.; 

test reports. 

4.  The notified body must examine the design and construction of each item of transportable 
pressure  equipment  and  during  manufacture  perform  appropriate  tests  to  ensure  its 
conformity  with the requirements  of the Directive which apply to it. 

4.1.  The  notified  body  must  affix  its  identification  number  or  have  it  affixed  to  the 
transportable pressure equipment and draw up a certificate  of conformity  for the tests 
carried  out.  This  certificate  must be kept for  a period  of ten years. 

4.2.  The manufacmrer,  or his authorized representative established within the Community, 
must ensure that the declaration of conformity  and certificate  of conformity  issued by 
the notified  body can be made available on request. 

Module H (full  quality assurance) 

1.  This  module  describes  the  procedure  whereby  the  manufacturer  who  satisfies  the 
obligations  of  section 2 ensures  and declares  that the transportable  pressure  equipment 
in  question  satisfies  the  requirements  of  the  Directive  which  apply  to  it.  The 
manufacturer,  or his authorized  representative  established  within the Community,  must 
affix  the  II  marking  to  each  item  of  transportable  pressure  equipment  and  draw  up a 
written  declaration  of  conformity.  The  II  marking  must  be  accompanied  by  the 
identification  number  of  the notified  body (type A inspection body) responsible  for  the 
surveillance  referred  to in section 4. 

2.  The manufacmrer  must implement an approved quality system for  design,  manufacture, 
final  inspection  and  testing  as  specified  in  section 3 and  be  subject  to  surveillance  as 
specified  in section 4. 

3.  Quality  system 

3.1.  The manufacmrer  must lodge an application for assessment  of his quality system with 

a notified  body  of his choice. 

52 

The application must include: 

- 

all  relevant  information  concerning  the  transportable  pressure  equipment  in 
question; 

- 

the documentation concerning the quality system. 

3.2.  The quality  system must ensure compliance of the transportable  pressure  equipment 

with the requirements  of the Directive which apply to it. 

All the elements,  requirements  and provisions  adopted by the manufacmrer  must be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  This  quality  system  documentation  must  permit  a 
consistent interpretation of the procedural and quality measures such as programmes, 
plans,  manuals  and records. 

It must contain in particular  an adequate description  of: 

- 

- 

- 

- 

- 

- 

- 

the quality objectives and the organizational structure, responsibilities  and powers 
of the management with regard to the quality of the design and to product quality; 

the technical  design specifications,  including standards,  that will be applied; 

the design  control  and design verification  techniques,  processes  and  systematic 
measures that will be used when designing the transportable pressure  equipment; 

the  corresponding  manufacturing,  quality  control  and  quality  assurance 
techniques,  processes  and systematic  measures  that will be used; 

the  examinations  and  tests  to  be  carried  out  before,  during,  and  after 
manufacture,  and the frequency  with which they will be carried  out; 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  or approvals  of the personnel  concerned; 

the means of monitoring the achievement of the required  transportable  pressure 
equipment design and quality  and the effective  operation of the quality  system. 

3.3.  The notified body must assess the quality system to determine whether it satisfies  the 

requirements  referred  to in 3.2. 

The auditing  team must have at least  one member  with experience  of  assessing  the 
transportable pressure equipment concerned.  The assessment procedure must include 
a visit to the manufacmrer's  premises. 

53 

The decision must be notified to the manufacmrer.  The notification must contain the 
conclusions of the examination and the reasoned assessment decision.  Provision must 
be made for  an appeals procedure. 

3.4.  The manufacmrer  must undertake  to fulfil  the obligations  arising  out of the quality 
system as approved  and to ensure that it remains  satisfactory  and  efficient. 

The manufacmrer,  or his authorized representative established within the Community, 
must inform  the notified  body that has approved  the quality system  of any intended 
adjustment  to the quality system. 

The notified body must assess the proposed changes and decide whether the modified 
quality  system  will  still  satisfy  the  requirements  referred  to  in  3.2  or  whether  a 
reassessment  is required. 

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

4,  Surveillance under the responsibility  of the notified  body 

4.1.  The purpose of this surveillance is to make sure that the manufacturer  duly fulfils  the 

obligations  arising  out of the approved  quality  system. 

4.2.  The manufacmrer  must allow the notified body access for  inspection purposes  to the 
locations of design,  manufacture,  inspection,  testing and storage and provide it with 
all necessary  information,  in particular: 

- 

- 

- 

the quality  system  documentation; 

the quality records provided for  in the design part of the quality system,  such as 
results  of analyses,  calculations,  tests,  etc.; 

the quality records provided for  in the manufacmring  part of the quality system, 
such as inspection reports  and test data, calibration data,  reports  concerning the 
qualifications  of the personnel  concerned,  etc. 

4.3.  The notified  body must carry  out periodic audits to make sure that the  manufacmrer 
maintains and applies the quality system and provide the manufacmrer  with an audit 
report.  The  frequency  of  periodic  audits  must  be  such  that  a full  reassessment  is 
carried  out every  three years. 

4.4. 

In  addition  the notified  body  may pay unexpected  visits  to the manufacmrer.  The 
need for  such additional visits, and the frequency  thereof,  will be determined  on the 
basis  of  a  visit  control  system  operated  by  the  notified  body. 
In  particular,  the 
following  factors  must be considered  in the visit control  system: 

54 

- 

- 

- 

- 

- 

the category  of the equipment; 

the results  of previous  surveillance visits; 

the need to follow  up corrective  action; 

special conditions  linked to the approval  of the system,  where applicable; 

significant  changes in manufacturing  organization,  policy  or techniques. 

During such visits the notified body may carry  out or have carried  out tests to verify 
if necessary  that the quality system is functioning  correctly.  The notified  body must 
provide the manufacmrer  with a visit report and, if a test has taken place, with a test 
report. 

5.  The  manufacmrer  must,  for  a  period  of  ten  years  after  the  last  of  the  transportable 
pressure  equipment  has  been  manufactured,  keep  at  the  disposal  of  the  national 
authorities: 

- 

- 

- 

the documentation referred  to in the second indent of the second subparagraph of 3.1 ; 

the adjustments  referred  to in the second  subparagraph  of  3.4; 

the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  last 
subparagraph  of  3.3, the last  subparagraph  of  3.4,  and in 4.3  and 4.4. 

6.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information 
concerning the quality system approvals which it has withdrawn,  and,  on request,  those 
it has issued. 

Each  notified  body  must  also  communicate.to  the  other  notified  bodies  the  relevant 
information  concerning* the quality  system approvals  it has withdrawn  or  refused. 

Module HI 

(full quality assurance with design examination and special surveillance of 
the final test) 

1. 

In addition to the requirements  of module H,  the following  apply: 

(a) 

the manufacmrer  must lodge an application for examination of the design with the 
notified  body  (type A inspection body); 

(b) 

the  application  must  enable  the  design,  manufacture  and  operation  of  the 
transportable  pressure  equipment  to be understood,  and enable conformity  with 
the relevant  requirements  of the Directive  to be assessed. 

55 

It must include: 

(c) 

(d) 

the technical design specifications,  including standards, which have been applied; 

the necessary  supporting  evidence for their adequacy.  This supporting  evidence 
must include the results  of tests carried out by the appropriate  laboratory  of the 
manufacmrer  or on his behalf; 

the notified  body must examine the application and where the design meets the 
provisions  of  the  Directive  which  apply  to  it  issue  an  EC  design-examination 
certificate  to the applicant.  The certificate  must contain the conclusions  of  the 
examination,  the conditions  for  its validity,  the necessary  data for  identification 
of  the  approved  design  and,  if relevant,  a description  of  the  functioning  of the 
transportable  pressure  equipment; 

inform 

that  has 

the  notified  body 

the  applicant  must 
the 
EC design-examination  certificate  of  all modifications  to  the  approved  design. 
Modifications  to the approved design must receive additional approval from  the 
notified  body that  issued  the EC design-examination  certificate  where  they may 
affect  conformity  with  the  requirements  of  the  Directive  or  the  prescribed 
conditions  for  use  of  the  transportable  pressure  equipment.  This  additional 
approval  must  be  given  in  the  form  of  an  addition  to  the  original  EC 
design-examination  certificate; 

issued 

(e)  each notified body must also communicate to the other notified bodies the relevant 
information  concerning the EC design-examination  certificates  it has withdrawn 
or  refused. 

Final assessment  is subject  to increased  surveillance  in the form  of unexpected  visits 
by  the  notified  body.  In  the  course  of  such  visits,  the  notified  body  must  conduct 
examinations  on the transportable  pressure  equipment. 

56 

ANNEX V 

PART II 

PROCEDURES FOR PERIODIC INSPECTION 

Module 1 (periodic inspection of product) 

1. 

2. 

This module describes  the procedure whereby an owner ensures  and declares that the 
transportable  pressure  equipment  subject  to  the provisions  of  section  3 continues  to 
meet the requirements  of this Directive. 

The owner must take all measures  necessary  to ensure that the conditions of use and 
of  maintenance,  in particular  during filling, assure  the  continued  conformity  of  the 
transportable pressure equipment with the requirements of this Directive.  The owner, 
or his authorised representative established within the Community, must affix  the date 
of  his  periodic  inspection  alongside  the  II  marking  to  all  transportable  pressure 
equipment and draw up a declaration of  conformity. 

3. 

The inspection body (type A,B or C) must perform  the appropriate examinations and 
tests in order to check the conformity  of the transportable pressure equipment with the 
relevant requirements  of the Directive by examining and testing every  product. 

3.1.  All transportable  pressure  equipment must be examined  individually  and  appropriate 
tests, as set out in the Annexes to Directives 94/55/EC and 96/49/EC, must be carried 
out in order  to verify  their conformity  with the requirements  of those Directives. 

3.2.  The inspection body  (type A,  B or C) must  affix  its  identification  number  or  have it 
affixed  to  each  product  being  periodically  inspected  immediately  after  the  date  of 
periodic  inspection and* draw up a written certificate  of  conformity. 

3.3.  The owner must keep a copy of the declaration of conformity  required  under  section 
2, as well as the certificate  of conformity  required under section 3.2. until at least the 
next periodic  inspection. 

57 

Module 2  (periodic inpection through quality assurance) 

1. 

This  module  describes  the  procedure  whereby  the  owner  or  his  authorised 
representative  who satisfies  the obligations  of section 2 ensures  and declares  that the 
transportable  pressure  equipment continues to meet the requirements  of the Directive. 
The owner or his authorised representative established in the Community must affix the 
date  of  periodic  inspection  alongside  the  II  marking  to  all  transportable  pressure 
equipment and draw up a declaration of conformity.  The date of periodic  inspection 
must  be  accompanied  by  the  identification  number  of  the  notified  body  (type  A 
inspection body) responsible  for  surveillance  as specified  in point 4. 

2. 

The  owner  or  his authorised  representative  must operate an approved  quality  system 
for the periodic inspection and tests of the equipment as specified  in section 3, and  be 
subject  to surveillance  as specified  in point 4. 

3.  Quality  system 

3.1.  The owner  or his  authorised  representative  must  lodge an application for  assessment 
of his quality system for the transportable  pressure  equipment with a notified  body of 
his choice. 

The application must include: 

all relevant information  on the transportable pressure  equipment being submitted 
for  periodic  inspection; 

the documentation regarding  the quality  system. 

3.2.  Under  the  quality  system,  each  item  of  transportable  pressure  equipment  must  be 
examined  and  appropriate  tests  must be carried  out in order  to ensure  its  conformity 
with the requirements  set out  in the Annexes to Directives  94/55/EC  and 96/49/EC. 
All  the elements,  requirements  and provisions  adopted  by the manufacmrer  must be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  This  quality  system  documentation  must  permit  a 
consistent  interpretation  of the quality programmes,  plans,  manuals  and records. 

It must contain  in particilar  an adequate description  of: 

the quality objectives and the organisational structure, responsibilities and powers 
of  the  management  with  regard  to  the  quality  of  the  transportable  pressure 
equipment; 

the examinations  and tests to be carried  out for  the periodic  inspection; 

the means of monitoring  the effective  operation of the quality  system; 

58 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports  concerning  the qualifications  or approvals  of the personnel  concerned. 

3.3.  The notified  body must assess  the quality system to determine whether  it satisfies  the 

requirements  referred  to in section 3.2. 

The  auditing  team  must  have  at  least  one  member  with  experience  of  assessing  the 
transportable  pressure  equipment concerned.  The assessment  procedure  must include 
an inspection  visit to the manufacturer's  premises. 

The  decision  must  be  notified  to  the  owner  or  his  authorised  representative.  The 
notification  must  contain  the  conclusions  of  the  examination  and  the  reasoned 
assessment  decision. 

3.4  The owner or his authorised representative must undertake to discharge the obligations 
arising  from  the quality system  as approved and to ensure that it remains  satisfactory 
and  efficient. 

The  owner  or  his authorised  representative  must inform  the notified  body  which has 
approved  the quality  system  of any intended adjustment  to the quality  system. 

The notified  body must assess  the proposed changes and decide whether the  modified 
quality  system  will still satisfy  the requirements  referred  to in section 3.2  or whether 
a reassessment  is required. 

It  must  notify  its  decision  to  the  owner  or  his  authorised  representative.  The 
notification  must  contain  the  conclusions  of  the  examination  and  the  reasoned 
assessment  decision. 

4. 

Surveillance under  the responsiblity  of the notified body 

4.1  The  purpose  of  surveillance  is  to  make  sure  that  the  owner  or  his  authorised 
representative  duly fulfils  the obligations  arising  out of the approved  quality  system. 

4.2  The  owner  or  his  authorised  representative  must  allow  the notified  body  access  for 
inspection  purposes  to the locations  of  inspection,  testing  and  storage  and provide  it 
with all necessary  information,  in particular: 

the quality  system  documentation; 

the technical  documentation; 

the quality  records,  such as inspection reports  and test data,  reports  concerning 
the qualifications  of the personnel  concerned,  etc. 

59 

4.3  The  notified  body must carry  out periodic  audits to make sure  that the owner  or his 
authorised  representative  maintains  and  applies  the  quality  system  and  provide  the 
owner  or his authorised  representative  with an audit report. 

4.4 

In addition the notified body may pay unexpected visits to the owner or his authorised 
representative.  During such visits, the notified body may carry out or have carried out 
tests to verify  if necessary that the quality system is functioning correctly.  The notified 
body must provide the owner or his authorised  representative  with a visit report  and, 
if a test has taken place, with a test report. 

5. 

The owner must, for a period often years from the date of the last periodic inspection 
of the transportable pressure equipment, hold at the disposal of the national authorities: 

the documentation referred  to in the second  indent of 3.1; 

the adjustments  referred  to in the second paragraph  of  3.4; 

the decisions and reports from  the notified body which are referred  to in the last 
paragraph  of  3.4,  and in 4.3 and 4.4. 

60 

ANNEX VI 

MODULES TO BE FOLLOWED FOR CONFORMITY  ASSESSMENT 

The following  table indicates  which modules of conformity  assessment  in accordance  with 
Annex V,  part I shall be followed  for  transportable  pressure  equipment provided  for  under 
Article 2. 

Type of transportable pressure equipment 

Modules 

Receptacles  of Class  2 (not more than  100 MPa.litre)  Al,  or 

Receptacles  of  Class  2  (100 - 300 MPa.litre) 

B in combination with CI 

H,  or 
B in combination  with E,  or 
6  in combination with CI 

Receptacles  of Class  2  (more than 300 MPa.litre), 
including demountable  tanks,  tank containers 
portable  tanks),  tanks  of tank wagons,  tanks of 
battery  vehicles,  tanks  of tank vehicles 

G,  or 
HI,  or 
B in combination with D, or 
B in combination with F 

61 

ANNEX VII 

MARK  OF  CONFORMITY 

The conformity  mark  shall take the following  form  : 

If the mark is reduced or enlarged,  the proportions of the above drawing must be respected. 

The various components of the mark have substantially the same vertical dimensions, which 

may not be less than 5 mm. 

This  minimum dimension may be waived for  small-scale devices. 

62 

ISSN 0254-1475 

COM(96) 674  final 

DOCUMENTS 

EN 

07  15  02 

Catalogue number  :  CB-CO-96-686-EN-C 

ISBN  92-78-13551-8 

Office  for  Official  Publications of the European  Communities 

L-2985  Luxembourg 

C%