EuropeAid /114385/D/SV/CY Assessment and administration capacity building or t!e !armonisation "it! t!e #e" Approac!

directi$es

%#&'()A*%'# +EA&+E*

to t!e implementation o D%(EC*%VE

,-/.3/EC
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/ED

Information Leaflet on PED directive

EuropeAid /114385/D/SV/C

/ressure E0uipment Directi$e

Information Leaflet on PED directive

EuropeAid /114385/D/SV/C

'VE(V%E1
The Pressure Equipment Directive (97/23/EC) was adopted b the European Par!iament and the European Counci! in "a #997$ %o!!owin& a transition period the Pressure Equipment Directive became ob!i&ator throu&hout the European 'nion (rom 29 "a 2))2$ *t has been transposed into C prus !e&is!ation with t!e Essential (e0uirements 2/ressure E0uipment3 (egulations o .4435 P$*$ 3##/2))3 (pub!ished #+$,$2))3)$ The Directive arises (rom the European Communit -s Pro&ramme (or the e!imination o( technica! barriers to trade and is (ormu!ated under the ./ew 0pproach to Technica! 1armonisation and 2tandards.$ *ts purpose is to harmoni3e nationa! !aws o( "ember 2tates re&ardin& the desi&n4 manu(acture4 testin& and con(ormit assessment o( pressure equipment and assemb!ies o( pressure equipment$ *t there(ore aims to ensure the (ree p!acin& on the mar5et and puttin& into service o( the equipment concerned within the European 'nion and the European Economic 0rea$ %ormu!ated under the /ew 0pproach4 the Directive provides (or a (!e6ib!e re&u!ator environment that does not impose an detai!ed technica! so!ution$ This approach a!!ows European industr to deve!op new techniques thereb increasin& internationa! competitiveness$ The Pressure Equipment Directive is one o( a series o( technica! harmoni3ation Directives (or machiner 4 !i(ts4 simp!e pressure vesse!s4 persona! protective equipment4 etc$ The Directive concerns manu(acturers o( items such as pressure vesse!s4 pressurised stora&e containers4 heat e6chan&ers4 steam &enerators4 boi!ers4 industria! pipin&4 sa(et devices and pressure accessories$ 2uch pressure equipment is wide! used in the process industries (oi! 7 &as4 chemica!4 pharmaceutica!4 p!astics and rubber and the (ood and bevera&e industr )4 hi&h temperature process industr (&!ass4 paper and board)4 ener& production and in the supp! o( uti!ities4 heatin&4 air conditionin& and &as stora&e and transportation$ 'nder the Communit re&ime o( the Directive4 pressure equipment and assemb!ies above speci(ied pressure and/or vo!ume thresho!ds must8 be sa(e9 meet essentia! sa(et requirements coverin& desi&n4 manu(acture and testin&9

satis( appropriate con(ormit assessment procedures9 and carr the CE mar5in& and other in(ormation$ Pressure equipment and assemb!ies be!ow the speci(ied pressure / vo!ume thresho!ds must8 be sa(e9 be desi&ned and manu(actured accordin& to sound en&ineerin& practice9 and bear speci(ied mar5in&s (but not the CE mar5in&)$

*E()S 6SED
Essential sa ety re0uirements 2ES(s3 !a down the necessar sa(et e!ements (or protectin& pub!ic interest$ Essentia! sa(et requirements (or desi&n4 manu(acture4 testin&4 mar5in&4 !abe!!in&4 instructions and materia!s4 usua!! written in &enera! terms4 are mandator and must be met be(ore products ma be p!aced on the mar5et in the European Communit $ Con ormity Assessment must be underta5en b the manu(acturer and/or noti(ied bod 4 dependin& on the cate&or o( the equipment4 in order to demonstrate that the essentia! sa(et requirements are met$ Con ormity Assessment )odules7 The /ew 0pproach has introduced a modu!ar approach to con(ormit assessment4 thereb subdividin& it into a number o( independent activities$ "odu!es di((er accordin& to the t pe o( assessment (e$&$ documentar chec5s4 t pe approva!4 desi&n approva!4 qua!it assurance) and the or&anisation carr in& out the assessment (i$e$ the manu(acturer or a third part )$ Sound Engineering /ractice app!ies to equipment that is not sub:ect to con(ormit assessment but must be desi&ned and manu(actured in accordance with the sound en&ineerin& practice o( a "ember 2tate in order to ensure sa(e use$ That equipment must ensure that desi&n and manu(acture ta5es into account a!!

Information Leaflet on PED directive

EuropeAid /114385/D/SV/C

re!evant (actors in(!uencin& sa(et durin& the intended !i(etime$ The equipment must be accompanied with adequate instructions (or use and must bear the identi(ication o( the manu(acturer$ The responsibi!it (or comp!iance with the Directive !ies so!e! with the manu(acturer$ #oti ied 8ody is a semi;o((icia! or private technica! or&anisation appointed b "ember 2tates4 either (or approva! and monitorin& o( the manu(acturers- qua!it assurance s stem or (or direct product inspection$ 0 /oti(ied <od ma be appointed (or certain products/product cate&ories or (or certain modu!es$ (ecognised *!ird /arty 'rganisations are appointed b "ember 2tates to carr out the approva! o( we!din& procedures and personne! as we!! as non;destructive testin& personne!$ 6ser inspectorates are appointed b "ember 2tates to carr out the tas5s o( noti(ied bodies within their own companies under "odu!es 0#4 C#4 % and = on! $ (The CE mar5in& shou!d not be a((i6ed to pressure equipment and assemb!ies assessed b user inspectorates)$ CE mar9ing dec!ares the comp!etion o( con(ormit assessment and that the equipment or assemb! comp!ies with the provisions o( the Directive and meets the essentia! sa(et requirements$ /ublis!ed :armonised European Standards !ist is a speci(ic subset o( European 2tandards (E/4 produced b CE/ and avai!ab!e (rom the nationa! 2tandards *nstitutes) with particu!ar consideration o( the Essentia! 2a(et >equirements the re(erence number o( which is pub!ished in the ?((icia! @ourna! o( the European Commission$ The use o( a Pub!ished 1armonised 2tandard in the desi&n and manu(acture o( a product wi!! &ive the presumption o( con(ormit to those E2>s !isted in 0nne6 0 o( the Directive$

*:E D%(EC*%VE
C'VE(A;E The Directive app!ies to the desi&n4 manu(acture and con(ormit assessment o( pressure equipment and assemb!ies o( pressure equipment with ma6imum a!!owab!e pressure &reater than )4A bar above atmospheric pressure and covers8 Pressure equipment ; vesse!s4 pipin&4 sa(et accessories and pressure accessories$ Bhere app!icab!e4 pressure equipment inc!udes e!ements attached to pressurised parts4 such as (!an&es4 no33!es4 coup!in&s4 supports4 !i(tin& !u&s4 etc$ Cesse!s ; housin&s desi&ned and bui!t to contain (!uids under pressure$ Pipin& ; pipin& components intended (or the transport o( (!uids4 when connected to&ether (or inte&ration into a pressure s stem$ 2a(et accessories ; devices desi&ned to protect pressure equipment a&ainst the a!!owab!e !imits bein& e6ceeded$ Pressure accessories ; devices with an operationa! (unction and havin& pressure bearin& housin&s$ 0ssemb!ies ; severa! pieces o( pressure equipment assemb!ed b a manu(acturer to constitute an inte&rated and (unctiona! who!e$

E<C+6S%'#S *n a number o( cases pressure equipment ; a!thou&h desi&ned (or a ma6imum a!!owab!e pressure above the !imit ; is e6c!uded4 (or e6amp!e8 equipment4 which is a!read re&u!ated at E' !eve!9 equipment presentin& a minor pressure ha3ard (cate&or * o( the Directive)4 which is covered b Directives on machiner 4 !i(ts4 !ow vo!ta&e4 medica! devices4 &as app!iances and on e6p!osive atmospheres9 equipment4 which does not present an si&ni(icant pressure ha3ard4 such as (or distribution o( water4 radiators and pipin& (or hot water heatin& s stems4 carbonated drin5 containers9 equipment4 which presents a si&ni(icant pressure ha3ard4 but (or which neither the (ree circu!ation aspect nor the sa(et aspect necessitated its inc!usion4 e$&$ hi&h vo!ta&e switch &ear$

Information Leaflet on PED directive

EuropeAid /114385/D/SV/C

Equipment protot pes to be e6hibited at trade (airs do not have to con(orm with the requirements o( the Directive as !on& as appropriate! !abe!!ed and sa(et measures are ta5en be(ore p!acin& on the mar5et$ &(EE )'VE)E#* "ember 2tates o( the E' ma not4 on the &rounds o( ha3ards due to pressure4 prohibit4 restrict or impede the p!acin& on the mar5et and puttin& into service o( pressure equipment and assemb!ies4 which comp! with the provisions o( the Directive$ "ember 2tates are to presume that pressure equipment and assemb!ies bearin& the CE mar5in& and accompanied b the EC Dec!aration o( Con(ormit satis( the provisions o( the Directive$ SA&E;6A(D /('CED6(E "ember 2tates are4 however4 to per(orm mar5et survei!!ance and ta5e a!! appropriate measures to withdraw (rom the mar5et pressure equipment or assemb!ies bearin& the CE mar5in& which is !iab!e to endan&er the sa(et o( peop!e and4 where appropriate4 domestic anima!s or propert $ /('D6C* C+ASS%&%CA*%'# *n order to determine how the Directive wi!! app! to speci(ic items o( pressure equipment4 a manu(acturer needs to c!assi( the pressure equipment into one o( (our con(ormit assessment cate&ories8 Cate&ories * to *C$ * re!ates to the !owest4 cate&or *C to the hi&hest4 ha3ard cate&or $ Equipment c!assi(ied be!ow Cate&or * come under .2ound En&ineerin& Practice. (2EP) and are not sub:ect to con(ormit assessment procedures$ *n order to determine which cate&or an item o( equipment (a!!s into the manu(acturer needs to identi( 8 the t pe o( equipment ; vesse! / steam &enerators / pipin&4 the state o( the intended (!uid contents ; &aseous or !iquid4 and the (!uid &roup o( the intended contents ; =roup # or =roup 2$ ;roup 1 comprises those (!uids c!assi(ied accordin& to the Directive D7/A,+/EEC4 as amended4 on the c!assi(ication o( dan&erous substances as8 e6p!osive e6treme! (!ammab!e hi&h! (!ammab!e (!ammab!e (where the ma6imum a!!owab!e temperature is above (!ashpoint) ver to6ic to6ic

o6idisin& ;roup . comprises a!! other (!uids inc!udin& water/steam$ 0ccordin& to the above c!assi(ication4 Tab!e # in 0nne6 2 o( the Directive determine the app!icab!e con(ormit assessment cate&or (*4 **4 *** or *C)$ *able 1= Product C!assi(ication and re!evant Directive Tab!e/=raph VESSE+S State o Contents &luid ;roup (e er to *able/;rap! 2Anne> %% o /ED3 * # =as ** 2 * 3 Eiquid ** , A * D S*EA) ;E#E(A*'(S =as ** 7 * + /%/%#; Eiquid ** 9

%!uid =roup * F dan&erous9 %!uid =roup ** F others

Information Leaflet on PED directive

EuropeAid /114385/D/SV/C

?n each o( these Tab!es/=raphs (#;9) ma6imum a!!owab!e pressure (P2) (bar) is p!otted a&ainst4 (or vesse!s4 the vo!ume in !itres4 C (E)4 and (or pipin&4 the nomina! si3e (D/)$ These tab!es have up to (ive bands re!atin& to the c!assi(ication (2EP4 *4 **4 *** or *C)$ Demarcation !ines on each tab!e indicate the upper !imit o( ma6imum a!!owab!e pressure and vo!ume4 or nomina! si3e4 (or each cate&or $ The manu(acturer has to p!ot the ma6imum a!!owab!e pressure and vo!ume4 or nomina! si3e4 (or their piece o( equipment on the re!evant Tab!e/=raph to identi( which cate&or the item o( equipment (a!!s into$ *n &enera!4 the !ower the pressure and the vo!ume4 the !ower the cate&or (or the equipment$ Pressure accessories8 Tab!es/=raphs # to , (or vesse!s or Tab!es/=raphs D to 9 (or pipin& in 0nne6 ** are app!icab!e dependin& on whether the vo!ume (C)4 or the nomina! si3e (D/)4 is considered appropriate (or c!assi(ication o( the pressure accessor $ Bhere both the vo!ume and the nomina! si3e are considered appropriate4 the pressure accessor must be c!assi(ied in the hi&hest cate&or $ 2a(et accessories8 These are &enera!! c!assi(ied under cate&or *C$ 2a(et accessories manu(actured (or speci(ic equipment ma be c!assi(ied in the same cate&or as the equipment the protect$ 0ssemb!ies8 2peci(ic provisions are app!icab!e which are based on the c!assi(ication o( the individua! parts o( pressure equipment o( which the assemb! is composed$ *EC:#%CA+ (E?6%(E)E#*S The Directive requires that a!! pressure equipment and assemb!ies within its scope must be sa(e when p!aced on the mar5et and put into service$ %or equipment (a!!in& under Gsound en&ineerin& practiceH (2EP) the essentia! requirements and the certi(ication procedures are not app!icab!e$ Pressure Equipment under cate&ories *4 **4 *** and *C must meet the essentia! requirements &iven in 0nne6 * o( the Directive$ 0ssemb!ies which inc!ude at !east one item o( pressure equipment c!assi(ied in cate&ories * to *C wi!! a!so be required to meet the essentia! sa(et requirements$ These inc!ude e6tensive requirements (or desi&n4 manu(acturin&4 testin&4 mar5in& and !abe!!in& and materia!s$ The manu(acturer is ob!i&ed to eva!uate the ha3ards in order to identi( those that app! to his equipment$ 1e must desi&n4 manu(acture and chec5 his equipment to ensure its sa(et with respect to its use under reasonab! (oreseeab!e conditions$ *n addition4 the manu(acturer must interpret and app! the essentia! requirements in such a wa as to ta5e account o( the state;o(;the;art at the time o( desi&n$ The !atter requirement hi&h!i&hts the deve!opin& character o( the essentia! requirements that is inherent in the new approach Directives$ Bith respect to materia!s the manu(acturer o( pressure equipment must adhere to the essentia! sa(et requirements b usin& appropriate materia!s8 which comp! with harmonised standards4 covered b European 0pprova! o( "ateria!s4 or eva!uated b a particu!ar materia! appraisa!$ European 0pprova! o( "ateria!s is a technica! document de(inin& the characteristics o( materia!s intended (or repeated use in the manu(acture o( pressure equipment the t pe o( which is /?T a!read covered b a harmonised standard$ /oti(ied bodies issue these documents$ The noti(ied bod sha!! determine and per(orm the appropriate inspections and tests to certi( the con(ormit o( the t pes o( materia! with the correspondin& requirements o( the Directive$ 2pecia! >equirements are &iven in addition to the app!icab!e requirements (or equipment (a!!in& with the scope o( -%ired or otherwise heated pressure with a ris5 o( overheatin&-$ 2peci(ic quantitative requirements (or certain pressure equipment materia!s supp!ement the essentia! requirements (or the pressure equipment to which the app! $ Equipment manu(actured to harmonised European standards is presumed to comp! with the essentia! sa(et requirements$ The European Committee (or 2tandardisation (CE/) is producin& a series o( 1armonised European 2tandards in support o( the Directive$ The wor5 pro&ramme inc!udes product and supportin& standards$ Product standards inc!ude un(ired pressure vesse!s4 she!! and water tube boi!ers4 pipin& and sa(et va!ves$ 2upportin& standards inc!ude we!din&4 non;destructive testin& and materia!s$

Information Leaflet on PED directive

EuropeAid /114385/D/SV/C

Permanent :oinin& o( components4 which contribute to the pressure resistance o( the equipment4 and components4 which are direct! attached to them4 must be carried out b suitab! qua!i(ied personne! accordin& to suitab!e operatin& procedures$ %or certain cate&ories o( pressure equipment in cate&ories **4 *** and *C operatin& procedures and personne! must be approved b a competent third part 4 which at the manu(acturers discretion4 ma be a noti(ied bod or a third part or&anisation reco&nised b a "ember 2tate$ To carr out these approva!s the third part must per(orm e6aminations and tests as set out in the appropriate harmonised standards or equiva!ent e6aminations or tests$ C'#&'()%*Y ASSESS)E#* *able .= Con(ormit 0ssessment "odu!es (or each cate&or Category % %% Con ormity Assessment )odules 0 0# D# E# <# I D <# I % <IE < IC# 1 <ID <I% = 1#

%%%

%V

<e(ore p!acin& pressure equipment re!ated to cate&ories * to *C on the mar5et4 the equipment has to be sub:ect to the appropriate con(ormit assessment procedures (modu!es)$ 0ccordin& to the cate&or o( the equipment4 manu(acturers are &iven a choice o( the assessment procedures as shown in Tab!es 2 and 3$ "anu(acturers ma chose either a procedure based on product contro! or a procedure based on qua!it s stems$ %urthermore4 the modu!es attributed to a hi&her ha3ard cate&or ma be used in !ower cate&ories$ %or con(ormit assessment o( assemb!ies an item o( pressure equipment4 which is part o( an assemb! 4 is assessed accordin& to the Tab!es (0nne6 **) and an assessment is carried out on the inte&ration o( each item$ The modu!es (or products in Cate&ories **4 *** and *C require the invo!vement o( noti ied bodies appointed b "ember 2tates4 either in the approva! and monitorin& o( the manu(acturersH qua!it s stem or in direct product inspection$ (ecognised t!ird@party organisations ma a!so be appointed b "ember 2tates to carr out the approva! o( we!din& procedures and personne! and non;destructive testin& personne! as required (or pressure equipment assemb!ies in Cate&ories **4 ** and *C$ 6ser inspectorates ma a!so be appointed b "ember 2tates to carr out the tas5s o( noti(ied bodies within their own or&anisations under "odu!es 0#4 C#4 % and = on! $ *n these cases4 the CE mar5in& shou!d not be a((i6ed to pressure equipment and assemb!ies assessed b user inspectorates$

Information Leaflet on PED directive

EuropeAid /114385/D/SV/C

*able 3= Con(ormit 0ssessment Procedure (or each modu!e )odule A A1 Con ormity Assessment /rocedure *nterna! production contro! *nterna! production contro! with monitorin& o( (ina! assessment EC t pe J e6amination EC desi&n J e6amination "onitorin& o( (ina! assessment /rocedure Description "anu(acturer ensures and dec!ares that pressure equipment satis(ies the requirements o( the Directive$ *n addition to procedure o( modu!e 04 the manu(acturer inc!udes monitorin& o( (ina! assessment b noti(ied bod $ 0 noti(ied bod ascertains and attests that a representative e6amp!e o( the production meets the provisions o( the Directive$ 0 noti(ied bod ascertains and attests that the desi&n o( an item meets the app!icab!e provisions o( the Directive$ "anu(acturer4 or authorised representative4 ensures and dec!ares that the pressure equipment is in con(ormit with the t pe4 as described in the EC t pe ; e6amination certi(icate and satis(ies the requirements o( the Directive$ "anu(acturer ensures and dec!ares that the pressure equipment con(orms to the t pe4 described in the EC t pe ; e6amination certi(icate4 or the EC desi&n J e6amination certi(icate4 and satis(ies the app!icab!e requirements$ "anu(acturer ensures and dec!ares that pressure equipment satis(ies the requirements o( the Directive$ "anu(acturer ensures and dec!ares that the equipment is in con(ormit with the t pe4 described in the EC t pe ; e6amination certi(icate and satis(ies the requirements o( the Directive$ "anu(acturer ensures and dec!ares that the equipment satis(ies the requirements o( the Directive$ "anu(acturer4 or authorised representative4 ensures and dec!ares that the pressure equipment is in con(ormit with the t pe4 as described in the EC t pe ; e6amination certi(icate4 or the EC desi&n J e6amination certi(icate4 and satis(ies the requirements o( the Directive$ The manu(acturer ensures and dec!ares that the pressure equipment4 which has been issued with a certi(icate o( con(ormit (or tests carried out4 satis(ies the requirements o( the Directive$ "anu(acture ensures and dec!ares that the pressure equipment satis(ies the requirements o( the Directive$ "anu(acture ensures and dec!ares that the pressure equipment satis(ies the requirements o( the Directive$

8 81 C1

Kua!it assurance (or production4 (ina! inspection and testin& Kua!it assurance (or production4 (ina! inspection and testin& Kua!it assurance (or (ina! inspection and testin& Kua!it assurance (or (ina! inspection and testin& Product veri(ication

D1

E1 &

'nit veri(ication

: :1

%u!! qua!it assurance %u!! qua!it assurance with desi&n e6amination and monitorin& o( (ina! assessment

DEC+A(A*%'# '& C'#&'()%*Y A#D CE@)A(A%#; ?nce con(ormit assessment has been comp!eted4 and i( the equipment or assemb! comp!ies with the provision o( the Directive4 the manu(acturer is required to a((i6 the CE;mar5in& to each item o( pressure equipment or assemb! and draw up a Dec!aration o( Con(ormit $