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Packaging 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)

50.99 FDIS or proof approved for publication

Z076 more

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Corrigendum 1

50.60 Close of voting. Proof returned by secretariat

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Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

40.20 DIS ballot initiated: 12 weeks

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Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods

40.20 DIS ballot initiated: 12 weeks

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Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

40.20 DIS ballot initiated: 12 weeks

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Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

40.20 DIS ballot initiated: 12 weeks

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Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

40.20 DIS ballot initiated: 12 weeks

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Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)

60.60 Standard published

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Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

90.20 Standard under periodical review

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Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

90.92 Standard to be revised

Z076 more

Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods

90.92 Standard to be revised

Z076 more

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

90.92 Standard to be revised

Z076 more

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

90.20 Standard under periodical review

Z076 more

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

90.92 Standard to be revised

Z076 more

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

90.92 Standard to be revised

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Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

90.20 Standard under periodical review

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Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

90.20 Standard under periodical review

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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60 Standard published

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