ISO 11607-2:2019

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

standard by International Organization for Standardization , 02/01/2019

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Full Description

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.

It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

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Document History

  1. ISO 11607-2:2019

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    viewing


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

    • Most Recent

  2. ISO 11607-2:2006/Amd1:2014


    - Amendment 1

    • Historical Version

  3. ISO 11607-2:2006


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

    • Historical Version

  4. ISO 11607:2003


    Packaging for terminally sterilized medical devices

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 11607-2:2019/Amd1:2023


    - Amendment 1: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management

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Product Details

Edition:

2nd

Published:

02/01/2019

Number of Pages:

20

Same As:

BS EN ISO 11607-2:2020, DIN EN ISO 11607-2