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

SS-EN-ISO-11607-2 - 2020 EDITION - CURRENT


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 2020 EDITION - Jan. 20, 2020
 FOR 2020 EDITION AMENDMENT 11 - June 21, 2022

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.

To find similar documents by classification:

11.080.30 (Sterilized packaging)


Medical devices

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Designation Name

SS-EN ISO 11607-2:2020

Revision Level

2020 EDITION

Status

Current

Publication Date

Jan. 20, 2020

Language(s)

English

Page Count

24

International Equivalent

EN ISO 11607-2:2020(IDT); ISO 11607-2:2019(IDT)