资源描述:
《EN 13824-2004 Sterilization of medical devices - Aseptic processing of 》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、EUROPEANSTANDARDEN13824NORMEEUROPÉENNEEUROPÄISCHENORMNovember2004ICS11.080.01EnglishversionSterilizationofmedicaldevices-Asepticprocessingofliquidmedicaldevices-RequirementsStérilisationdesdispositifsmédicaux-TraitementSterilisationvonMedizinprodukten-Aseptische
2、Herstellungaseptiquedesdispositifsmédicauxliquides-ExigencesflüssigerMedizinprodukte-AnforderungenThisEuropeanStandardwasapprovedbyCENon14October2004.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanS
3、tandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,G
4、erman).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Es
5、tonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITÉEUROPÉENDENORMALISATIONEURO
6、PÄISCHESKOMITEEFÜRNORMUNGManagementCentre:ruedeStassart,36B-1050Brussels©2004CENAllrightsofexploitationinanyformandbyanymeansreservedRef.No.EN13824:2004:EworldwideforCENnationalMembers.EN13824:2004(E)ContentspageForeword..........................................
7、...................................................................................................................5Introduction......................................................................................................................................
8、...................61Scope............................................................................................................................................