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ISO 11607-2:2019

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

📝 Amendments Available

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About This Item

 

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.

 

Product Details

Edition:
2nd
Published:
02/01/2019
Number of Pages:
20
File Size:
1 file , 1.2 MB
Same As:
BS EN ISO 11607-2:2020, BS EN ISO 11607-2:2017, DIN EN ISO 11607-2
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 11607-2:2019

    👀currently
    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