11.080.30 : Sterilized packaging

UNE-EN ISO 11607-1:2020/A1:2024

UNE-EN ISO 11607-1:2020/A1:2024

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Packaging 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)

€81.00

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UNE-EN ISO 11607-2:2020/A1:2024

UNE-EN ISO 11607-2:2020/A1:2024

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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)

€69.00

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UNE-EN ISO 11607-1:2017

UNE-EN ISO 11607-1:2017

Superseded Historical

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)

€95.00

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UNE-EN ISO 11607-2:2017

UNE-EN ISO 11607-2:2017

Superseded Historical

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)

€73.00

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UNE-EN 868-2:2017

UNE-EN 868-2:2017

Superseded Historical

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

€73.00

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UNE-EN 868-3:2017

UNE-EN 868-3:2017

Superseded Historical

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

€69.00

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UNE-EN 868-4:2017

UNE-EN 868-4:2017

Superseded Historical

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

€62.00

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UNE-EN 868-6:2017

UNE-EN 868-6:2017

Superseded Historical

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

€69.00

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UNE-EN 868-7:2017

UNE-EN 868-7:2017

Superseded Historical

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

€77.00

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UNE-EN ISO 11607-1:2020

UNE-EN ISO 11607-1:2020

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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)

€106.00

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UNE-EN ISO 11607-2:2020

UNE-EN ISO 11607-2:2020

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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

€69.00

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UNE-EN ISO 11607-1:2020/A11:2022

UNE-EN ISO 11607-1:2020/A11:2022

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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)

€58.00

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UNE-EN ISO 11607-2:2020/A11:2022

UNE-EN ISO 11607-2:2020/A11:2022

Active Most Recent

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

€58.00

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NF EN ISO 11607-1, S98-052-1 (08/2009)

NF EN ISO 11607-1, S98-052-1 (08/2009)

Superseded Historical

Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems

€89.33

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UNE-EN 868-5:2019

UNE-EN 868-5:2019

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

€69.00

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