灭菌包装——CSSD管理者的检查清单.pdf

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1、Sterilization WrapChecklist for CSSD ManagerName:Menno DUFOUR,Ph.D.Affiliation:AHLSTROMComplying with standards for sterilization wrap Complying with standards for sterilization wrap HospitalsHospitalsIn mostcountrieshospitals mustcomplywith standards(ISO,EN,etc)-not an option.StandardsStandardsMake

2、 the lives of manufacturers and end-users easier;the details have been alreadydiscussedbystandards committees(i.e.:ISO TC198WG7&CEN TC102WG4)NationalNational bestbest practicespracticesIn each countryare written according to ISO 11607-1&EN 868-2.GuidanceGuidance DocumentDocumentPublishedon WFHSSWebs

3、ite:Home WfhssGuidelines(wfhss-)ISO 11607ISO 11607-1 1 TerminologyTerminology3.11 Packaging System3.11 Packaging SystemCombination of the sterile barrier system and protective packaging3.14 Protective Packaging 3.14 Protective Packaging Configuration of materials designed to prevent damage to the st

4、erile barrier system and its contents from the time of their assembly until the point of use3.23 3.23 SterileSterile BarrierBarrier SystemSystemMinimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of useSterile Barrier SystemProtectivePa

5、ckagingNew New symbolssymbols for packaging system for packaging system Asolid line solid line which indicates a Sterile Barrier System layer(maintaining sterility)Adashed line dashed line which indicates a Protective Packaging layer that is not a validated microbial barrier Symbols developed by the

6、 Sterile Barrier Association(SBA)and published in ISO 11607-1&ISO 15223-1 guidance-doc-symbols-201908-1.pdf(sterilebarrier.org)SterilizationSterilization Wrap Wrap SelectionSelectionPack weightManual handling regulation limitsPack Life Cycle global stressSMSWetlaid NonwovensCrepe paperType of Steril