EN 868-7-1999消毒医疗设备用包装材料和系统.经环氧乙烷或辐射消毒的医用热密封包装的生产用

~__~~STD*CENENBb8-7-ENGL19993404589O200902998LIRATIFIEDEUROPEANTEXTIEN868-7:1999IEuropeanStandardsonlyexistformallyasnationaltranspositions(Le.aBSENfortheUK)ofacommonlyagreed“ratified”text.ThisdocumentisaratifiedtextwhichwillshortlybepublishedasaBSEN.ItisbeingmadeavailableinadvanceofitsformalpublicationtogiveinterestedpartiesearlyaccesstothetechnicalinformationwhichtheBSENwillcontain.WhentheBSENisformallypublisheditwillbesuppliedtoyouautomatically,withoutanyadditionalcharge.Purchasersofthisratifiedtextshouldbeawareofthefollowinglimitationswhenusingthedocument.TheBSENmaycontainadditionalinformationinthenationalforewordornationalannex,FullrightsconferredbycompliancewiththestandardmayonlybegrantedbyreferencetotheformalnationaltranspositionofthetextasaBSEN.ThisratifiedtextwasapprovedbyCENíCENELECinitsthreeofficiallanguagesonthedategivenbelow.UnderCENíCENELECrules,BSIisobligedtopublishitsnationaltranspositionwithinsixmonthsofthisdate.Thisratifiedtextwasapprovedon1999-05-13i,-e-NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWCopyrightEuropeanCommitteeforStandardizationProvidedbyIHSunderlicensewithCENNotforResaleNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,-`-`,,`,,`,`,,`---EUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMEN86&7June1999ICs11.O;55.040EnglishversionPackagingmaterialsandsystemsformedicaldeviceswhicharetobesterilized-Part7:Adhesivecoatedpaperforthemanufactureofheatsealablepacksformedicaluseforsterilizationbyethyleneoxideorirradiation-RequirementsandtestmethodsMatériauxetsystèmesd'emballagespourlesdisposiüism8&cauxdevaniêtrestérilisØs-Partie7:Papierenduitd'adhésiípourlafabricationd'emballagesthermoscellablesàusagem6dicalpourstérilisationàl'oxyded'éthylèneouparirradiation-Exigencesetméthodesd'essaiVerpadcungsmatenalienund-SystemefürzusterilisierendeMedizinprodukie-Teil7:KlebemittelbeschichtetesPapierfürdieHerstellungvonheißsiegelfähigenVerpackungenfürmedizinischeZweckezurSterilisationmitEthylenoxidoderStrahlen-AnforderungenundPrüfverfahrenThisEuropeanStanderdwasapprovedbyCENon13May1999.CENmembersareboundtocomplywiththeCEWCENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicatreferencesconcerningsuchnationalstaMardsmaybeobtainedonappiicaîbntotheCentralSecretariatortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnoufiedtotheCentralSecretariathasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAusiria,Belgium,CzechRepublic.Denmaik.Finland,France,Germany,Greece.Iceland.Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom.EUROPEANCOMMIITEEFORSTANDARDIZATIONCOMITEEUROPkENDENORMALISATIONEUROPÄISCHESKOMITEEFORNORMUNGCentralSecmtariat:~8deStassart,368-10508ruuelrQ1999CENAllrightsofexploitationinanyformandbyanymeansresewedworldwideforCENnationalMembers.Ref.No.ENû68-7:1999ECopyrightEuropeanCommitteeforStandardizationProvidedbyIHSunderlicensewithCENNotforResaleNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,-`-`,,`,,`,`,,`---~~STD-CENEN8b8-7-ENGLLe19934045890200904760Page2EN868-7~1999ContentsPageForeword......................................................................3Introduction....................................................................31scope......................................................................32Normativereferences..........................................................43Definitions...................................................................44Requirements................................................................4AnnexA(normative)Methodforthedeteminationofwaterrepellency........................8AnnexB(normative)Methodforthedeterminationofporesize.............................9AnnexC(normative)Methodforthedeterminationofregularityofheatsealadhesivecoatingsonpaper................................14AnnexD(normative)Methodforthedeterminationofmassperunitareaofuncoatedpaperandadhesivecoating................................15AnnexE(normative)Methodforthedeterminationofsealstrengthofadhesivecoating............17AnnexF(informative)Dimensionsandtolerances.......................................18AnnexG(informative)Bibliography..................................................19CopyrightEuropeanCommitteeforStandardizationProvidedbyIHSunderlicensewithCENNotforResaleNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,-`-`,,`,,`,`,,`---STD-CENEN8b8-7-ENGL1999634045890200905bT76Page3EN868-7:1999ForewordThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEMC102Sterilizersformedicalpurposes',thesecretariatofwhichisheldbyDIN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyDecember1999,andconflictingnationalstandardsshallbewithdrawnatthelatestbyDecem