BS EN 1041-2008

InformationsuppliedbythemanufacturerofmedicaldevicesICS01.110;11.040.01;11.120.01BRITISHSTANDARDBSEN1041:2008NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBSEN1041:2008NationalforewordThisBritishStandardistheUKimplementationofEN1041:2008.ItsupersedesBSEN1041:1998,whichwillbewithdrawnon3August2011.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/210/3,Generalterminologyandsymbols.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon31August2008©BSI2008ISBN9780580546617Amendments/corrigendaissuedsincepublicationDateCommentsEUROPEANSTANDARDEN1041NORMEEUROPÉENNEEUROPÄISCHENORMAugust2008ICS01.110;11.040.01;11.120.01SupersedesEN1041:1998EnglishversionInformationsuppliedbythemanufacturerofmedicaldevicesInformationsfourniesparlefabricantdedispositifsBereitstellungvonInformationendurchdenHerstellervonmédicauxMedizinproduktenThisEuropeanStandardwasapprovedbyCENon4July2008.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-1050BrusselsruedeStassart,35B-1050Brussels©2008CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedRef.No.EN1041:2008EworldwideforCENnationalMembersandforCENELECMembers.BSEN1041:2008BSEN1041:2008EN1041:2008(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..........................................................................................................................85.2.1Applicability...........