89-686(人身保護(hù)設(shè)備)萊茵技術(shù) 汽車行業(yè)標(biāo)準(zhǔn)

89/686/EEContheapproximationofthelawsoftheMemberStatesrelatingtopersonalprotectiveequipment各成員國(guó)關(guān)于人身保護(hù)設(shè)備的89/686/EEC指令法律協(xié)調(diào)國(guó)家汽車質(zhì)量監(jiān)督檢驗(yàn)中心萊茵技術(shù)（上海）有限公司北京辦事處

EN中文ConsolidatedTEXT統(tǒng)一文本producedbytheCONSLEGsystemoftheOfficeforOfficialPublicationsoftheEuropeanCommunities歐洲共同體官方出版物辦公室CONSLEG體系出版:Numberofpages:72頁(yè)數(shù)：72頁(yè)OfficeforOfficialPublicationsoftheEuropeanCommunities歐洲共同體官方出版物辦公室

1989L0686—EN—20.11.2003—002.001Thisdocumentismeantpurelyasadocumentationtoolandtheinstitutionsdonotassumeanyliabilityforitscontents?BCOUNCILDIRECTIVEof21December1989ontheapproximationofthelawsoftheMemberStatesrelatingtopersonalprotectiveequipment(89/686/EEC)(OJL399,30.12.1989,p.18)Amendedby:OfficialJournal：Nopagedate?M1CouncilDirective93/68/EECof22July1993 L220.1.?M2CouncilDirective93/95/EECof29October1993 L276.11.9.11?M3Directive96/58/ECoftheEuropeanParliamentandtheL236.44.18.9.1996.Councilof3September1996 ?M4Regulation(EC)No1882/2003oftheEuropeanParliamentandoftheCouncilof29September2003 L284.1.31.10.2003共72頁(yè)第1頁(yè)1989L0686——2003年11月本文件純屬文件編制工具，有關(guān)機(jī)構(gòu)對(duì)其內(nèi)容不承擔(dān)任何責(zé)任。?B委員會(huì)指令1989年12月21日各成員國(guó)關(guān)于人身保護(hù)設(shè)備的89/686/EEC指令法律協(xié)調(diào)（89/686/EEC）（OJL399，1989年12月30日，第18頁(yè)）由如下指令修訂：公報(bào):編號(hào)頁(yè)碼日期?1993年7月22日委員會(huì)指令93/68/EEC?21993年10月29日委員會(huì)指令93/95/EEC?31996年9月6日歐洲議會(huì)及委員會(huì)指令96/58/ECL236 44 18.9.1996?4條例（EC）No1882/2003L284 2003年9月29日歐洲議會(huì)及委員會(huì)指令共72頁(yè)第2頁(yè)1989L0686—EN—20.11.2003—002.001BCOUNCILDIRECTIVEof21December1989ontheapproximationofthelawsoftheMemberStatesrelatingtopersonalprotectiveequipment(89/686/EEC)THECOUNCILOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanEconomicCommunity,andinparticularArticle100athereof,HavingregardtotheproposalfromtheCommission(1),IncooperationwiththeEuropeanParliament(2),HavingregardtotheopinionoftheEconomicandSocialCommittee(3),Whereasitisnecessarytoadoptmeasureswiththeaimofprogressivelyestablishingtheinternalmarketoveraperiodexpiringon31December1992;whereastheinternalmarketcomprisesanareawithoutinternalfrontiersinwhichthefreemovementofgoods,persons,servicesandcapitalisguaranteed;WhereasvariousMemberStateshave,overrecentyears,adoptedprovisionscoveringnumerousitemsofpersonalprotectiveequipmentwithaviewinparticulartosafeguardingpublichealth,improvingsafetyatworkandensuringuserprotection;Whereasthesenationalprovisionsareoftenverydetailedasregardstherequirementsrelatingtothedesign,manufacture,qualitylevel,testingandcertificationofpersonalprotectiveequipmentwithaviewtotheprotectionofindividualsagainstinjuryandillness;共72頁(yè)第3頁(yè)1989L0686——2003年11月B1989年12月21日歐洲共同體委員會(huì)各成員國(guó)關(guān)于人身保護(hù)設(shè)備的89/686/EEC指令法律協(xié)調(diào)（89/686/EEC）歐洲共同體委員會(huì)，考慮到建立歐洲經(jīng)濟(jì)共同體的條約，特別是其第100a條；歐洲共同體委員會(huì)提交的議案（1）；以及歐洲議會(huì)的意見（2）；經(jīng)濟(jì)和社會(huì)委員會(huì)的意見（3）；鑒于有必要采取措施，以期能在1992年12月31日之前，逐步建立歐洲共同體內(nèi)部市場(chǎng)；鑒于歐洲共同體內(nèi)部市場(chǎng)是一個(gè)沒有內(nèi)部邊界，保證商品、人員、服務(wù)和資本自由流通的區(qū)域；近年來許多成員國(guó)特別以保護(hù)公眾健康、提高工作安全以及確保保護(hù)使用者為目的，已通過了大量有關(guān)人身保護(hù)設(shè)備的條款；各國(guó)的這些條款從防止人身的傷害出發(fā)，對(duì)人身保護(hù)設(shè)備的設(shè)計(jì)、制造、質(zhì)量水平、檢測(cè)和認(rèn)證的要求通常極為詳盡；共72頁(yè)第4頁(yè)1989L0686—EN—20.11.2003—002.001▼BWhereas,inparticular,thenationalprovisionsrelatingtosafetyatworkmaketheuseofpersonalprotectiveequipmentcompulsory;whereasmanyrequirementsobligeemployerstomakeappropriatepersonalprotectiveequipmentavailabletotheirstaffintheabsenceorinadequacyofprioritypublicprotectionmeasures;WhereasnationalprovisionsrelatingtopersonalprotectiveequipmentdiffersignificantlyfromoneMemberStatetoanother;whereastheymaythusconstituteabarriertotradewithdirectconsequencesforthecreationandoperationofthecommonmarket;Whereasitisnecessarytoharmonizethesedifferentnationalprovisionsinordertoensurethefreemovementoftheseproducts,withoutinanywayreducingthevalidlevelsofprotectionalreadyrequiredintheMemberStates,andtoprovideforanynecessaryincreasetherein;WhereastheprovisionsgoverningthedesignandmanufactureofpersonalprotectiveequipmentlaiddowninthisDirectivewhicharefundamental,inparticular,toattemptstoensureasaferworkingenvironmentarewithoutprejudicetoprovisionsrelatingtotheuseofsuchequipmentandtheorganizationofthehealthandsafetyofworkersattheworkplace;WhereasthisDirectivedefinesonlythebasicrequirementstobesatisfiedbypersonalprotectiveequipment;whereas,inordertofacilitateproofofconformitywiththosebasicrequirements,itisessentialthatharmonizedEuropeanstandardsbeavailablerelating,inparticular,tothedesignandmanufactureof,andthespecificationsandtestmethodsapplicableto,personalprotectiveequipment,sincecompliancetherewithconfersontheseproductsapresumptionofconformitywiththeabovementionedbasicrequirements;whereassuchharmonizedEuropeanstandardsaredrawnupbyprivatebodiesandmustretainthestatusofnon-mandatorytexts;whereas,tothisend,theEuropeanCommitteeforStandardization(CEN)andtheEuropeanCommitteeforElectrotechnicalStandardization(Cenelec)arethecompetentbodieswhichhavebeenauthorizedtoadoptharmonizedstandardsinaccordancewiththegeneralguidelinesgoverningcooperationbetweentheCommissionandthosetwoinstitutionsratifiedon13November1984;whereas,forthepurposesofthisDirective,aharmonizedstandardisatextcontainingtechnicalspecifications(aEuropeanstandardoraharmonizationdocument)whichhasbeenadoptedbyoneorbothoftheabovementionedbodiesattheinstigationoftheCommissioninaccordancewithCouncilDirective83/189/EECof28March1983layingdownaprocedurefortheprovisionofinformationinthefieldoftechnicalstandardsandregulations(1),asamendedbyDirective88/182/EEC(2),andpursuanttotheabovementionedgeneralguidelines;共72頁(yè)第5頁(yè)1989L0686——2003年11月▼B各成員國(guó)關(guān)于人身保護(hù)設(shè)備的條款彼此差異很大；鑒于它們因此會(huì)構(gòu)成貿(mào)易壁壘，從而直接影響歐洲共同體內(nèi)部市場(chǎng)的建立與運(yùn)行；必須協(xié)調(diào)各國(guó)這些不同的條款，以確保這些產(chǎn)品在不以任何方式降低各成員國(guó)要求的現(xiàn)有合理保護(hù)水平的情況下自由流通，并保證這一水平得到必要的提高；本指令中規(guī)定的關(guān)于人身保護(hù)設(shè)備的設(shè)計(jì)和制造的強(qiáng)制性條款，特別對(duì)試圖保證有一個(gè)安全的工作環(huán)境來說是必不可少的，它們并不會(huì)損害有關(guān)使用此類用具和保護(hù)工人在工作場(chǎng)所的健康和安全的條款；因此，按照1984年11月13日批準(zhǔn)的歐洲共同體委員會(huì)與歐洲標(biāo)準(zhǔn)化委員會(huì)（CEN）和歐洲電工標(biāo)準(zhǔn)化委員會(huì)（CENELEC）的合作總指導(dǎo)原則，歐洲標(biāo)準(zhǔn)化委員會(huì)和歐洲電工標(biāo)準(zhǔn)化委員會(huì)被認(rèn)可為有權(quán)批準(zhǔn)協(xié)調(diào)標(biāo)準(zhǔn)的主管機(jī)構(gòu)；對(duì)本指令而言，協(xié)調(diào)標(biāo)準(zhǔn)是包含技術(shù)規(guī)范的文件（歐洲標(biāo)準(zhǔn)或協(xié)調(diào)文件），它是由上述兩個(gè)標(biāo)準(zhǔn)機(jī)構(gòu)或其中之一受歐洲共同體委員會(huì)的委托，按照1983年3月28日歐洲共同體理事會(huì)關(guān)于在技術(shù)標(biāo)準(zhǔn)和法規(guī)（1）領(lǐng)域提供信息程序的83/189/EEC指令（后經(jīng)88/182/EEC（2）指令修訂），并遵循上述合作總指導(dǎo)原則而批準(zhǔn)的；(1)OJNoL109，1983年4月26日，第8頁(yè)(2)OJNoL81，1988年3月26日，第75頁(yè)。共72頁(yè)第6頁(yè)1989L0686—EN—20.11.2003—002.001▼BWhereas,pendingtheadoptionofharmonizedstandards,whichwillbeverynumerousbecauseofthebroadscopeofapplicationandthepreparationofwhichwithinthedeadlinesetforthecreationoftheinternalmarketwillinvolveagreatdealofwork,itwouldbeadvisabletomaintain,onatransitionalbasisandsubjecttotherequirementsoftheTreaty,thestatusquoasregardsconformitywithexistingnationalstandardsforpersonalprotectiveequipmentnotcoveredbyaharmonizedstandardatthedateofadoptionofthisDirective;Whereas,giventhegeneralandhorizontalnatureoftheroleplayedbytheStandingCommitteesetuppursuanttoArticle5ofDirective83/189/EECinCommunitystandardizationpolicyand,moreparticularly,itspartinthepreparationofstandardizationapplicationsandtheoperationoftheexistingEuropeanstandardizationagreements,thisStandingCommitteeisespeciallysuitedtothetaskofassistingtheCommissioninmonitoringtheconformityofharmonizedstandardsthroughouttheCommunity;Whereascompliancewiththesetechnicalrequirementsmustbemonitoredinordertoensureadequateuserandthird-partyprotection;whereasexistingmonitoringproceduresmaydifferappreciablyfromoneMemberStatetoanother;whereas,inordertoavoidnumerouscheckswhichmerelyimpedethefreemovementofpersonalprotectiveequipment,provisionshouldbemadeforthemutualrecognitionofinspectionsconductedbytheMemberStates;whereas,inordertofacilitatesuchrecognition,itisnecessary,inparticular,tolaydownharmonizedCommunityproceduresandtoharmonizethecriteriatobetakenintoaccountinselectingthebodiesresponsibleforexamination,monitoringandverification;Whereasthelegislativeframeworkshouldbeimprovedsothatbothsidesofindustrywillmakeaneffectiveandappropriatecontributiontotheprocessofstandardization,HASADOPTEDTHISDIRECTIVE:CHAPTERISCOPE,PLACINGONTHEMARKETANDFREEMOVEMENTArticle11.ThisDirectiveappliestopersonalprotectiveequipment,hereinafterreferredtoas'PPE'.ItlaysdowntheconditionsgoverningitsplacingonthemarketandfreemovementwithintheCommunityandthebasicsafetyrequirementswhichPPEmustsatisfyinordertoensurethehealthprotectionandsafetyofusers.共72頁(yè)第7頁(yè)1989L0686——2003年11月B協(xié)調(diào)標(biāo)準(zhǔn)應(yīng)用范圍廣、數(shù)量多，并且要在建立歐洲共同體內(nèi)部市場(chǎng)的規(guī)定期限內(nèi)制定出來，工作量相當(dāng)大，因此在批準(zhǔn)這些協(xié)調(diào)標(biāo)準(zhǔn)之前，建議在過渡的基礎(chǔ)上并按照《歐洲共同體條約》的要求，維持現(xiàn)狀，即自通過本指令之日起，對(duì)于協(xié)調(diào)標(biāo)準(zhǔn)尚未涉及的人身保護(hù)設(shè)備，應(yīng)符合現(xiàn)行的國(guó)家標(biāo)準(zhǔn)；根據(jù)83/189/EEC指令建立的常設(shè)委員會(huì)在制定歐洲共同體標(biāo)準(zhǔn)化政策，特別是在編寫標(biāo)準(zhǔn)化委托書和實(shí)施現(xiàn)行歐洲標(biāo)準(zhǔn)化協(xié)議方面所起的作用具有普遍的同行業(yè)對(duì)比性質(zhì)，所以該常設(shè)委員會(huì)特別適合承擔(dān)協(xié)助歐洲共同體委員會(huì)監(jiān)督協(xié)調(diào)標(biāo)準(zhǔn)在歐洲共同體范圍內(nèi)是否得到遵守的任務(wù)；必須監(jiān)督并遵守這些技術(shù)要求，以確保對(duì)使用者和第三方的充分保護(hù)；各成員國(guó)現(xiàn)行的監(jiān)督程序可能有明顯的差別；鑒于各種重復(fù)檢驗(yàn)只會(huì)阻礙人身保護(hù)設(shè)備自由流通，為此應(yīng)對(duì)各成員國(guó)相互承認(rèn)各自的檢驗(yàn)結(jié)果作出規(guī)定；為便于實(shí)現(xiàn)這種相互承認(rèn)，必須特別規(guī)定歐洲共同體協(xié)調(diào)程序，并對(duì)在選擇檢驗(yàn)、監(jiān)督和驗(yàn)證的機(jī)構(gòu)時(shí)所應(yīng)考慮的準(zhǔn)則進(jìn)行協(xié)調(diào)；應(yīng)該對(duì)立法框架進(jìn)行改進(jìn)，以便工業(yè)的雙方都能對(duì)標(biāo)準(zhǔn)化進(jìn)程作出有效貢獻(xiàn)；各成員國(guó)已經(jīng)采用本指令：第1章適用范圍、投放市場(chǎng)和自由流通第1條1.本指令適用于人身保護(hù)設(shè)備，以下簡(jiǎn)稱“PPE”。本指令規(guī)定PPE在歐洲共同體內(nèi)投放市場(chǎng)和自由流通的條件，以及PPE為確保使用者的健康和安全必須滿足的基本安全要求。鑒于環(huán)境和經(jīng)濟(jì)要求，可以降低空氣污染和燃料消耗；鑒于理事會(huì)授予委員會(huì)對(duì)機(jī)動(dòng)車汽車規(guī)則進(jìn)行補(bǔ)充的權(quán)力，應(yīng)當(dāng)在顧問委員會(huì)內(nèi)的委員會(huì)和成員國(guó)之間進(jìn)行該程序的事先磋商；鑒于應(yīng)該在行駛計(jì)劃范圍內(nèi)就由主要公路和交通條件所保證的限速而起動(dòng)的不同限速裝置的發(fā)展進(jìn)行研究工作，共72頁(yè)第8頁(yè)1989L0686—EN—20.11.2003—002.001B2.ForthepurposesofthisDirective,PPEshallmeananydeviceorappliancedesignedtobewornorheldbyanindividualforprotectionagainstoneormorehealthandsafetyhazards.PPEshallalsocover:(a)aunitconstitutedbyseveraldevicesorapplianceswhichhavebeenintegrallycombinedbythemanufacturerfortheprotectionofanindividualagainstoneormorepotentiallysimultaneousrisks;(b)aprotectivedeviceorappliancecombined,separablyorinseparably,withpersonalnon-protectiveequipmentwornorheldbyanindividualfortheexecutionofaspecificactivity;(c)interchangeablePPEcomponentswhichareessentialtoitssatisfactoryfunctioningandusedexclusivelyforsuchequipment.3.AnysystemplacedonthemarketinconjunctionwithPPEforitsconnectiontoanotherexternal,additionaldeviceshallberegardedasanintegralpartofthatequipmentevenifthesystemisnotintendedtobewornorheldpermanentlybytheuserfortheentireperiodofriskexposure.4.ThisDirectivedoesnotapplyto:—PPEcoveredbyanotherdirectivedesignedtoachievethesameobjectivesasthisDirectivewithregardtoplacingonthemarket,freemovementofgoodsandsafety,—thePPEclassesspecifiedinthelistofexcludedproductsinAnnexI,independentlyofthereasonforexclusionmentionedinthefirstindent.Article21.MemberStatesshalltakeallappropriatemeasurestoensurethatthePPEreferredtoinArticle1maybeplacedonthemarketandbroughtintoserviceonlyifitpreservesthehealthandensuresthesafetyofuserswithoutprejudicetothehealthorsafetyofotherindividuals,domesticanimalsorgoods,whenproperlymaintainedandusedforitsintendedpurpose.2.ThisDirectiveshallbewithoutprejudicetotherightofMemberStatestolaydown—inconformitywiththeTreaty—anyrequirementswhichtheyconsidernecessarytoensureuserprotection,providedthatthisdoesnotgiverisetomodificationstoPPEwhichcouldresultinitsnon-conformitywiththeprovisionsofthisDirective.共72頁(yè)第9頁(yè)1989L0686——2003年11月▼B2.本指令所稱PPE系指任何供個(gè)人為防備一種或多種損害健康和安全的危險(xiǎn)而穿戴或持有的任何裝置或器具。PPE還應(yīng)包括：（a）由制造商整體組合的幾個(gè)裝置或器具整體裝配所構(gòu)成的，用于保護(hù)個(gè)人避免遭受一種或多種可能同時(shí)發(fā)生危險(xiǎn)的一種設(shè)備；（b）為進(jìn)行某種專門的活動(dòng)，由個(gè)人穿戴或持有的、與非人身保護(hù)設(shè)備組合的、可分開或不可分開的保護(hù)裝置或器具；（c）確保PPE正常工作并只供此種設(shè)備使用的必不可少的可互換PPE組件。3.同PPE一起投放市場(chǎng)，供其外接另一附加裝置的任何系統(tǒng)，即使它不是供使用者在始終存在危險(xiǎn)的期間永久穿戴或持有的，也應(yīng)視為該設(shè)備組成部分。4.本指令不適用于：—就商品投放市場(chǎng)、自由流通及其安全而言，其他指令所涉及的、旨在達(dá)到與本指令相同目的的PPE；—附錄Ⅰ所列的不適用產(chǎn)品清單中規(guī)定的，與以上所述的不適用理由無關(guān)的各類PPE。第2條1.各成員國(guó)應(yīng)采取一切適當(dāng)?shù)拇胧?，以確保本指令第1條所述的PPE在其按預(yù)定用途正確維護(hù)和使用時(shí)，只要能保護(hù)健康，并保證使用者和家畜的健康或安全，或商品的安全，即可投放市場(chǎng)并可使用。.2.本指令不應(yīng)損害各成員國(guó)根據(jù)《歐洲共同體條約》規(guī)定任何其認(rèn)為是必需的權(quán)利，以保證使用者得到保護(hù)，只要此種做法不會(huì)導(dǎo)致對(duì)PPE作出修改，從而使其不符合本指令的條款。共72頁(yè)第10頁(yè)1989L0686—EN—20.11.2003—002.001B3.MemberStatesshallnotpreventthepresentationattradefairs,exhibitionsandthelikeofPPEwhichisnotinconformitywiththeprovisionsofthisDirective,providedthatanappropriatenoticeisdisplayeddrawingattentiontothisfactandtheprohibitiononitsacquisitionand/oruseforanypurposewhatsoeveruntilithasbeenbroughtintoconformitybythemanufacturerorhisrepresentativeestablishedintheCommunity.Article3ThePPEreferredtoinArticle1mustsatisfythebasichealthandsafetyrequirementslaiddowninAnnexII.Article4M11.MemberStatesmaynotprohibit,restrictorhindertheplacingonthemarketofPPEorPPEcomponentswhichcomplywiththeprovisionsofthisDirectiveandwhichbeartheCEmarkingattestingtheirconformitytoalltheprovisionsofthisDirective,includingthecertificationproceduresinChapterII.B2.MemberStatesshallnotprohibit,restrictorimpedetheplacingonthemarketofPPEcomponentswhichdonotbearthe?MlCEmarking?,andwhichareintendedtobeincorporatedinPPE,providedthattheyarenotessentialtoitssatisfactoryfunctioning.Article51.MemberStatesshallregardasinconformitywiththebasicrequirementsreferredtoinArticle3thePPEreferredtoinArticle8(3)bearingthe?MlCEmarking?withrespecttowhichthemanufacturerisabletoproduce,ondemand,thedeclarationofconformityreferredtoinArticle12.共72頁(yè)第11頁(yè)1989L0686——2003年11月B3.各成員國(guó)不應(yīng)阻止不符合本指令條款的PPE在交易會(huì)、展覽會(huì)等場(chǎng)合展出，只要同時(shí)出示適當(dāng)?shù)耐ǜ嫣嵴?qǐng)注意這一事實(shí)，并寫明在制造商或其設(shè)在共同體的代表使之合格之前，禁止不管出于何種目的獲得和/或使用這類PPE。第3條本指令第1條所述的PPE必須滿足附錄Ⅱ規(guī)定的基本健康和安全要求。第4條▼M11.各成員國(guó)不得禁止、限制或阻礙符合本指令相關(guān)條款要求，包括第II認(rèn)證過程并加貼CE標(biāo)志的PPE或PPE部件投放市場(chǎng)。▼B2.各成員國(guó)不得禁止、限制或阻礙那些沒有加貼CE標(biāo)志、但預(yù)定安裝在PPE上的PPE部件投放市場(chǎng)，只要這些部件不是PPE正常工作所必不可少的。第5條1.各成員國(guó)對(duì)本指令第8條第3款所述的加貼了CE標(biāo)志、制造商能應(yīng)要求出示本指令第12條所述的合格聲明的PPE，應(yīng)視為符合本指令第3條所述的基本要求。共72頁(yè)第12頁(yè)1989L0686—EN—20.11.2003—002.001B2.MemberStatesshallpresumethatthePPEreferredtoinArticle8(2)satisfiesthebasicrequirementsreferredtoinArticle3ifitbearsthe?MlCEmarking?withrespecttowhichthemanufacturerisabletoproduce,ondemand,notonlythedeclarationreferredtoinArticle12butalsothecertificateissuedbythebodyofwhichnotificationhasbeengiveninaccordancewithArticle9attestingtotheirconformitytotherelevantnationalstandards,transposingtheharmonizedstandards,assessedattheECtypeexaminationlevelinaccordancewiththefirstindentofArticle10(4)(a)and(b).WhereamanufacturerhasnotappliedorhasonlypartlyappliedtheharmonizedstandardsorwheretherearenosuchstandardsthecertificateissuedbythebodyofwhichnotificationhasbeengivenmuststatetheconformitytothebasicrequirementsinaccordancewiththesecondindentofArticle10(4)(a)and(b).M2B4.TheCommissionshallpublishthereferencesoftheharmonizedstandardsintheOfficialJournaloftheEuropeanCommunities.MemberStatesshallpublishthereferencesofthenationalstandardstransposingtheharmonizedstandards.5.MemberStatesshallensurethatby30June1991appropriatestepsaretakentoenablebothsidesofindustrytohaveaninfluenceatnationallevelontheprocessofformulatingtheharmonizedstandardsandkeepingthemunderreview.M16.(a)WherethePPEissubjecttootherDirectivesconcerningotheraspectsandwhichalsoprovidefortheaffixingoftheCEmarking,thelattershallindicatethatthePPEisalsopresumedtoconformtotheprovisionsoftheotherDirectives.共72頁(yè)第13頁(yè)1989L0686——2003年11月B2.本指令第8條第2款所述PPE，如果加貼了CE標(biāo)志，制造商不僅能應(yīng)要求出示本指令第12條所述的合格聲明，而且能出示指定機(jī)構(gòu)按本指令第9條頒發(fā)的證書，證實(shí)他們已按本指令第10條第4款（a）第一項(xiàng)和（b）的規(guī)定，經(jīng)EC型式檢驗(yàn)評(píng)定符合依據(jù)協(xié)調(diào)標(biāo)準(zhǔn)轉(zhuǎn)換的有關(guān)國(guó)家標(biāo)準(zhǔn)，各成員國(guó)應(yīng)推定該P(yáng)PE符合本指令第3條所述的基本要求。如果制造商未采用或僅部分采用協(xié)調(diào)標(biāo)準(zhǔn)或者在沒有上述協(xié)調(diào)標(biāo)準(zhǔn)時(shí)，指定機(jī)構(gòu)所頒發(fā)的證書必須按照本指令第10條第4款（a）第二項(xiàng)和（b）的規(guī)定，聲明其符合基本要求。▼M24.歐洲共同體委員會(huì)應(yīng)在歐洲共同體官方公報(bào)上公布協(xié)調(diào)標(biāo)準(zhǔn)的編號(hào)。各成員國(guó)應(yīng)公布依據(jù)協(xié)調(diào)標(biāo)準(zhǔn)轉(zhuǎn)換的國(guó)家標(biāo)準(zhǔn)的編號(hào)。5.成員國(guó)應(yīng)確保在1991年6月30日以前采取適當(dāng)?shù)拇胧构I(yè)雙方能在國(guó)家一級(jí)對(duì)協(xié)調(diào)標(biāo)準(zhǔn)的制定和評(píng)審過程施加影響力。▼M16.（a）如果PPE在其他方面必須執(zhí)行其他的指令，并且這些指令還規(guī)定加貼CE合格標(biāo)志，則后者應(yīng)表明PPE也被推定為符合其他指令。共72頁(yè)第14頁(yè)1989L0686—EN—20.11.2003—002.001M1(b)However,whereoneormoreoftheseDirectivesallowthemanufacturer,duringatransitionalperiod,tochoosewhicharrangementstoapply,theCEmarkingshallindicateconformitytotheprovisionsonlyofthoseDirectivesappliedbythemanufacturer.Inthiscase,particularsoftheDirectivesapplied,aspublishedintheOfficialJournaloftheEuropeanCommunities,mustbegiveninthedocuments,noticesorinstructionsrequiredbytheDirectivesandaccompanyingsuchPPE.▼BArticle61.ShouldaMemberStateortheCommissionconsiderthattheharmonizedstandardsreferredtoinArticle5donotcompletelysatisfytherelevantbasicrequirementsreferredtoinArticle3,theCommissionortheMemberStateconcernedshallreferthemattertothecommitteecreatedpursuanttoDirective83/189/EEC(1),settingoutitsreasons.Thecommitteeshalldeliveranopinionwithoutdelay.Inthelightofthecommittee'sopinion,theCommissionshallnotifyMemberStatesofwhetherornotitisnecessarytowithdrawthestandardsconcernedfrompublicationsmadepursuanttoArticle5.▼M42.TheCommissionshallbeassistedbytheStandingCommittee,setupbyArticle6(2)ofDirective98/37/EC(1),hereinafterreferredtoas'theCommittee'.Itmaybeapprised,inaccordancewiththeprocedurereferredtointhisparagraph,ofanymattertowhichtheimplementationandpracticalapplicationofthisDirectivegiverise.Wherereferenceismadetothisparagraph,Articles3and7ofDecision1999/468/EC(2)shallapply,havingregardtotheprovisionsofArticle8thereof.TheCommitteeshalladoptitsrulesofprocedure.▼BArticle71.IfaMemberStatediscoversthatPPEbearingthe?MlCEmarking?andusedinaccordancewithitsintendedpurposecouldcompromisethesafetyofindividuals,domesticanimalsorproperty,itshalltakeallnecessarymeasurestoremovethatequipmentfromthe(1)共72頁(yè)第15頁(yè)1989L0686——2003年11月M1（b）但是，如果這些指令中有一個(gè)或幾個(gè)允許制造商在過渡階段選擇使用何種方案，則該CE標(biāo)志應(yīng)表明只符合制造商采用的指令。在這種情況下，在這些指令所要求的文件、通告或說明書中給出已在歐洲共同體官方公報(bào)上公布的指令細(xì)節(jié)，并隨附于PPE上。▼B第6條1.如果某一成員國(guó)或歐洲共同體委員會(huì)認(rèn)為本指令第5條所述的協(xié)調(diào)標(biāo)準(zhǔn)不完全符合第3條所述的有關(guān)基本要求，歐洲共同體委員會(huì)或該成員國(guó)應(yīng)將問題提交根據(jù)83/189/EEC（1）指令成立的常設(shè)委員會(huì)，并闡明其理由。該常設(shè)委員會(huì)應(yīng)對(duì)此及時(shí)提出意見。按照該常設(shè)委員會(huì)的意見，歐洲共同體委員會(huì)應(yīng)通知各成員國(guó)是否必須從根據(jù)本指令第5條發(fā)布的公告中撤銷該標(biāo)準(zhǔn)。M2.常務(wù)委員會(huì)應(yīng)該協(xié)助委員會(huì)創(chuàng)建指令98/37/EC（1）第六條第2款，以下簡(jiǎn)稱“委員會(huì)”。按照本段的流程，可以將指令帶來的所有實(shí)施及實(shí)際應(yīng)用問題予以通告。如果本段由參考，則考慮到第八條的要求，應(yīng)該采用指令1999/468/EC（2）的第3條和第7條。委員會(huì)采用采用其議事規(guī)則。▼B第7條1.某一成員國(guó)如發(fā)現(xiàn)加貼CE標(biāo)志的PPE在按其預(yù)定用途使用時(shí)可能會(huì)危及人身、家畜或財(cái)產(chǎn)的安全，則應(yīng)采取一切必要措施將上述設(shè)備撤出市場(chǎng)并禁止其銷售或自由流通。(1)OJNoL109，1983年4月26日，第8頁(yè)共72頁(yè)第16頁(yè)1989L0686—EN—20.11.2003—002.001BTheMember(a)failuretocomplywiththebasicrequirementsreferredtoinArticle3;(b)theunsatisfactoryapplicationofthestandardsreferredtoinArticle5;(c)ashortcominginthestandardsreferredtoinArticle5.2.TheCommissionshallinitiatediscussionswiththepartiesconcernedassoonaspossible.If,aftersuchconsultation,theCommissiondecidesthattheactiontakenwasjustified,itshallimmediatelyinformtheMemberStateconcernedandalltheotherMemberStatestothateffect.If,aftersuchconsultation,theCommissiondecidesthattheactiontakenwasnotjustified,itshallimmediatelyinformtheMemberStateconcernedandthemanufacturerorhisauthorizedrepresentativeestablishedintheCommunitytothateffect.Ifthedecisionreferredtoinparagraph1isinresponsetoashortcominginthestandards,theCommissionshallreferthemattertotheCommitteereferredtoinArticle6(1)iftheMemberState3.IfPPEwhichisnotinconformitywiththerelevantrequirementsbearsthe?MlCEmarking?,theMemberStateconcernedshalltaketheappropriatemeasureswithregardtothoseresponsibleforaffixingthemarkandshallinformtheCommissionandtheotherMember4.TheCommissionshallensurethattheMemberStatesarekeptinformedoftheprogressandresultsoftheprocedureprovidedforinthisArticle.(1)OJL207,23.7.1998,p.1.DirectiveasamendedbyDirective98/79/EC(OJL331,7.12.1998,p.1).(2)CouncilDecision1999/468/ECof28June1999layingdowntheproceduresfortheexerciseofimplementingpowersconferredontheCommission(OJL184,17.7.1999,p.23).共72頁(yè)第17頁(yè)1989L0686——2003年11月B該成員國(guó)應(yīng)立即將上述行動(dòng)通知?dú)W洲共同體委員會(huì)，闡明做出上述決定的理由，并應(yīng)特別說明不合格的原因是否由于：(a)不符合第5條所述的基本要求；(b)沒有正確實(shí)施第5條所述的標(biāo)準(zhǔn)；(c)本指令第5條所述標(biāo)準(zhǔn)有某種缺陷。2.歐洲共同體委員會(huì)應(yīng)盡快著手與有關(guān)方面進(jìn)行研究。如經(jīng)研究后，歐洲共同體委員會(huì)認(rèn)定所采取的措施合理，則應(yīng)立即就此通知該成員國(guó)和所有其他成員國(guó)。如經(jīng)研究后，歐洲共同體委員會(huì)認(rèn)定所采取的措施不合理，則應(yīng)立即就此通知該成員國(guó)和制造商或其設(shè)在共同體內(nèi)的授權(quán)代表。若本條第1款所述的決定是針對(duì)標(biāo)準(zhǔn)中存在的缺陷，且該成員國(guó)欲堅(jiān)持其決定，歐洲共同體委員會(huì)應(yīng)將此事提交本指令第6條第1款所述的常設(shè)委員會(huì)，并應(yīng)啟動(dòng)第6條第2款所述的程序。3.如果不符合相關(guān)要求的PPE加貼了CE標(biāo)志，有關(guān)成員國(guó)應(yīng)對(duì)加貼該標(biāo)志的責(zé)任方采取適當(dāng)措施，并應(yīng)就此通告委員會(huì)和其他成員國(guó)。4.歐洲共同體委員會(huì)應(yīng)保證及時(shí)向各成員國(guó)通報(bào)本條款規(guī)定的程序及其進(jìn)展情況和結(jié)果。（1）OJL207，1998年7月23日，第1頁(yè)。由指令98/79/EC修正的指令（OJL3311998年12月7日，第1頁(yè)）。（2）1999年6月28日委員會(huì)決定1999/468/EC給出了由委員會(huì)授予的行使實(shí)施權(quán)利的過程（OJL184，1999年7月17日，第23頁(yè)）。共72頁(yè)第18頁(yè)1989L0686—EN—20.11.2003—002.001BCHAPTERIICERTIFICATIONPROCEDURESArticle81.BeforeplacingaPPEmodelonthemarket,themanufacturerorhisauthorizedrepresentativeestablishedintheCommunityshallassemblethetechnicaldocumentationreferredtoinAnnexIIIsothatthiscan,ifnecessary,besubmittedtothecompetentauthorities.2.PriortotheseriesproductionofPPEotherthanthosereferredtoinparagraph3,themanufacturerorhisauthorizedrepresentativeestablishedintheCommunityshallsubmitamodelforECtype-examinationasreferredtoinArticle10.3.ECtype-examinationshallnotberequiredinthecaseofPPEmodelsofsimpledesignwherethedesignerassumestheusercanhimselfassessthelevelofprotectionprovidedagainsttheminimalrisksconcernedtheeffectsofwhich,whentheyaregradual,canbesafelyidentifiedbytheuseringoodtime.ThiscategoryshallcoverexclusivelyPPEintendedtoprotecttheweareragainst:—mechanicalactionwhoseeffectsaresuperficial(gardeninggloves,thimbles,etc.),—cleaningmaterialsofweakactionandeasilyreversibleeffects(glovesaffordingprotectionagainstdiluteddetergentsolutions,etc.),—risksencounteredinthehandlingofhotcomponentswhichdonotexposetheusertoatemperatureexceedingortodangerousimpacts(gloves,apronsforprofessionaluse,etc.),—atmosphericagentsofaneitherexceptionalnorextremenature(headgear,seasonalclothing,footwear,etc.),—minorimpactsandvibrationswhichdonotaffectvitalareasofthebodyandwhoseeffectscannotcauseirreversiblelesions(lightanti-scalpinghelmets,gloves,lightfootwear,etc.),——sunlight(sunglasses).共72頁(yè)第19頁(yè)1989L0686——2003年11月B第2章認(rèn)證程序第8條1.將一種PPE型號(hào)投放市場(chǎng)前，制造商或其設(shè)在歐洲共同體內(nèi)的授權(quán)代表應(yīng)編制附錄Ⅲ所述的技術(shù)文件，以便必要時(shí)提交主管當(dāng)局查閱。2.在成批生產(chǎn)除本條第3款所述外的PPE之前，制造商或其設(shè)在歐洲共同體內(nèi)的授權(quán)代表應(yīng)提交一種型號(hào)進(jìn)行本指令第10條所述的EC型式檢驗(yàn)。3.對(duì)于那些設(shè)計(jì)簡(jiǎn)單的PPE型號(hào)，當(dāng)設(shè)計(jì)者認(rèn)為使用者自己就可以評(píng)估對(duì)付最小危險(xiǎn)的保護(hù)程度時(shí)，可以不要求做EC型式檢驗(yàn)。最小危險(xiǎn)是指那些其影響是逐漸產(chǎn)生的，使用者在正常工作中可以安全地察覺出來的危險(xiǎn)。此類PPE應(yīng)僅限于保護(hù)穿戴防護(hù)設(shè)備者，以防止：—機(jī)械作用對(duì)表皮的影響（園藝手套、頂針等）；—影響不大且容易清除的清潔材料（用于防護(hù)稀釋清潔劑溶液等影響的手套）；—運(yùn)熱工件時(shí)遇到的危險(xiǎn)，此種危險(xiǎn)會(huì)使使用者置于50℃—用于性質(zhì)既非特殊、也非極端的大氣環(huán)境下的防護(hù)介質(zhì)（安全帽、季節(jié)性服裝、鞋襪等）；—不傷及身體重要部位和其影響不會(huì)造成不可挽回的損害的輕微碰撞和振動(dòng)（輕型頭盔、手套、輕型鞋襪等）；—陽光（太陽鏡）共72頁(yè)第20頁(yè)1989L0686—EN—20.11.2003—002.001B4.ProductionofPPEshallbesubject:(a)accordingtothemanufacturer'schoice,tooneofthetwoproceduresreferredtoinArticle11inthecaseofPPEofcomplexdesignintendedtoprotectagainstmortaldangeroragainstdangersthatmayseriouslyandirreversiblyharmthehealth,theimmediateeffectsofwhichthedesignerassumestheusercannotidentifyinsufficienttime.Thiscategoryshallcoverexclusively:—filteringrespiratorydevicesforprotectionagainstsolidandliquidaerosolsorirritant,dangerous,toxicorradiotoxicgases,—respiratoryprotectiondevicesprovidingfullinsulationfromtheatmosphere,includingthoseforuseindiving,—PPEprovidingonlylimitedprotectionagainstchemicalattackoragainstionizingradiation,—emergencyequipmentforuseinhigh-temperatureenvironmentstheeffectsofwhicharecomparabletothoseofanairtemperatureof100oormoreandwhichmayormaynotbecharacterizedbythepresenceofinfra-redradiation,flamesortheprojectionoflargeamountsofmoltenmaterial,—emergencyequipmentforuseinlow-temperatureenvironmentstheeffectsofwhicharecomparabletothoseofanairtemperatureof-50oCorless,—PPEtoprotectagainstfallsfromaheight,—PPEagainstelectricalrisksanddangerousvoltagesorthatusedasinsulationinhigh-tensionwork,M2B(b)theECdeclarationofconformityreferredtoinArticle12forallPPE.Article91.MemberStatesshallnotifytheCommissionandtheotherMemberStatesofthebodieswhichtheyhaveappointedtocarryouttheproceduresreferredtoinArticle8togetherwiththespecifictasksTheCommissionshallpublishintheOfficialJournaloftheEuropeanCommunitiesalistofthenotifiedbodiesandtheiridentificationnumbersandthetasksforwhichtheyhavebeennotified.TheCommissionshallensurethatthislistiskeptuptodate.共72頁(yè)第21頁(yè)1989L0686——2003年11月B4.PPE的生產(chǎn)應(yīng)遵循下述規(guī)定：（a）對(duì)于設(shè)計(jì)復(fù)雜、用于預(yù)防致命危險(xiǎn)或預(yù)防可能會(huì)嚴(yán)重且不可挽回地?fù)p害健康危險(xiǎn)的PPE，設(shè)計(jì)者估計(jì)使用者對(duì)于這種危險(xiǎn)的直接影響在充足的時(shí)間內(nèi)無法察覺，在這種情況下，由制造商選擇，實(shí)施本指令第11條所述的兩個(gè)程序中的一個(gè)。這類PPE應(yīng)僅限于：—防護(hù)固體或液體粉塵或刺激性、危險(xiǎn)性、毒性或輻射毒性氣體的過濾呼吸裝置；—用于完全與大氣隔絕的呼吸保護(hù)裝置，包括潛水用的呼吸保護(hù)裝置；—對(duì)化學(xué)腐蝕或電離輻射僅提供有限防護(hù)的PPE；—供高溫環(huán)境下使用的急救設(shè)備，在此環(huán)境下產(chǎn)生的影響與100℃—供低溫環(huán)境下使用的急救設(shè)備，在此環(huán)境下產(chǎn)生的影響與50℃—防備從高處跌落的PPE；—防備觸電危險(xiǎn)和危險(xiǎn)電壓或用于高壓作業(yè)中起絕緣作用的PPE。▼M2 B（b）所有的PPE都要附有本指令第12條所述的EC合格聲明。10.3.6.保證對(duì)在上述測(cè)試中表現(xiàn)出不符合性的任意一組樣本或試件做進(jìn)一步抽樣和測(cè)試。應(yīng)該采取全部必要步驟來恢復(fù)相應(yīng)產(chǎn)品的符合性。第9條1.各成員國(guó)應(yīng)將其指定負(fù)責(zé)執(zhí)行本指令第8條所述認(rèn)證程序的機(jī)構(gòu)、這些機(jī)構(gòu)被指定承擔(dān)的具體任務(wù)和歐洲共同體委員會(huì)事先指定給他們的編號(hào)通知?dú)W洲共同體委員會(huì)和其他成員國(guó)。歐洲共同體委員會(huì)應(yīng)在歐洲共同體官方公報(bào)上公布這些機(jī)構(gòu)的名稱及其編號(hào)以及這些機(jī)構(gòu)被指定承擔(dān)的任務(wù)清單。歐洲共同體委員會(huì)應(yīng)保證及時(shí)更新該清單。共72頁(yè)第22頁(yè)1989L0686—EN—20.11.2003—002.001B2.MemberStatesshallapplythecriterialaiddowninAnnexVinassessingthebodiestobeindicatedinsuchnotification.Bodiesmeetingtheassessmentcriterialaiddownintherelevantharmonizedstandardsshallbepresumedtofulfilthosecriteria.3.AMemberStateshallwithdrawitsapprovalfromsuchabodyifitestablishesthatthelatternolongersatisfiesthecriteriareferredtoinAnnexV.ItshallinformtheCommissionandtheotherMemberStatesECTYPE-EXAMINATIONArticle101.ECtype-examinationistheprocedurewherebytheapprovedinspectionbodyestablishesandcertifiesthatthePPEmodelinquestionsatisfiestherelevantprovisionsofthisDirective.2.A