CEN/TC 102

Registration number (WIID)Project No.TitleStatus
72114LVS EN ISO 11607-2:2020/A1:2023Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)Standarts spēkā
62249EN ISO 11607-1:2020Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)Standarts spēkā
58411EN ISO 11138-4:2017Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO/DIS 11138-4:2015)Standarts spēkā
40602EN ISO 15883-4:2018Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO/DIS 15883-4:2016)Standarts spēkā
72113LVS EN ISO 11607-1:2020/A1:2023Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)Standarts spēkā
77632EN 868-2:2025Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methodsStandarts spēkā
77630EN 868-4:2025Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methodsStandarts spēkā
61237EN ISO 15883-5:2021Washer disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO/DIS 15883-5:2019)Standarts spēkā
76196LVS EN 13060:2025Sterilizers for medical purposes - Small steam sterilizers - Requirements and testingStandarts spēkā
76196EN 13060:2025Sterilizers for medical purposes - Small steam sterilizers - Requirements and testingStandarts spēkā
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