EN-1041-2008-医疗器械厂商提供的信息(中英文版)

Informationsuppliedbythemanufacturerofmedicaldevices医疗器械厂商提供的信息ICS01.110;11.040.01;11.120.01BRITISHSTANDARDBSEN1041:2008NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBSEN1041:2008Nationalforeword国家前言ThisBritishStandardistheUKimplementationofEN1041:2008.ItsupersedesBSEN1041:1998,whichwillbewithdrawnon3August2011.此英国标准是英国执行的EN1041：2008，取代了英国标准EN1041：1998，将于2011年8月3日被孤立。TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210/3,Generalterminologyandsymbols.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.英国参与此制定是委托了技术委员会CH/210/3，常规术语和符号。包括此委员会代表的组织列表，如有需求可询问委员会秘书。此出版不包括协议中所有必要的规定。使用者负责正确的应用。依照英国标准不会协商法律规定的免疫性。ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31August2008此英国标准在标准准则和委员会的授权下于2008年8月31日出版©BSI2008ISBN9780580546617Amendments/corrigendaissuedsincepublication出版时颁布的修改DateCommentsEUROPEANSTANDARDEN1041NORMEEUROPÉENNEEUROPÄISCHENORMAugust2008ICS01.110;11.040.01;11.120.01SupersedesEN1041:1998EnglishversionInformationsuppliedbythemanufacturerofmedicaldevices医疗器械厂商提供的信息InformationsfourniesparlefabricantdedispositifsBereitstellungvonInformationendurchdenHerstellervonmédicauxMedizinproduktenThisEuropeanStandardwasapprovedbyCENon4July2008.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENorCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENand/orCENELECmemberintoitsownlanguageandnotifiedtotheCENManagementCentrehasthesamestatusastheofficialversions.CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommittees,respectively,ofAustria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom.CENManagementCentre:CENELECCentralSecretariat:ruedeStassart,36B-1050Brussels©2008CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedBSEN1041:2008BSEN1041:2008EN1041:2008(E)ContentsPageForeword.......................................................................................................................................................3Introduction...................................................................................................................................................41Scope..............................................................................................................................................52Normativereferences.....................................................................................................................53Termsanddefinitions.....................................................................................................................54Requirements..................................................................................................................................64.1General............................................................................................................................................64.2Units,symbolsandcolours............................................................................................................64.3Languageandcountryidentifiers..................................................................................................74.4Dates...............................................................................................................................................74.5Devicenomenclature......................................................................................................................74.5.1Identifiersofnomenclature..................................................................................................................74.5.2Devicecommonterms.........................................................................................................................74.5.3Batchcode;lotnumber;batchnumber;lotcode...............................................................................75Requirementsforprovisionofinformation...................................................................................75.1General............................................................................................................................................75.2Specificrequirements..........................................................................................................