Reference number
ISO 11607-2:2019
© ISO 2025
International Standard
ISO 11607-2:2019
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Edition 2
2019-02
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Published (Edition 2, 2019)
This publication was last reviewed and confirmed in 2024. Therefore this version remains current.

ISO 11607-2:2019

Language
Format
CHF 98
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2019-02
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 2
    Number of pages
     : 13
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.30 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Application of risk management

Edition 2023

Language
Format
CHF 18
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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