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

ISO-11607-2 - 2ND EDITION - CURRENT -- See the following: ISO-11607-2-AM1
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Included in this current edition are the following subparts:

 2ND EDITION - Feb. 1, 2019
 FOR 2ND EDITION AMENDMENT 1 SEE - Sept. 1, 2023

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 Number

ISO 11607-2:2019

Revision Level

2ND EDITION

Status

Current

Publication Date

Feb. 1, 2019

Committee Number

ISO/TC 198