Standard

SN EN ISO 11607-2:2020

Jul 2020 Current

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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Application of risk management (ISO 11607-2:2019/Amd 1:2023); Amendment A1 Current SN EN ISO 11607-2/A1:2023 Amendment from Publication date: Nov 2023 Version: Pages: 26 Language: English, French Services: Online, Online + Pdf
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); Amendment A11 Current SN EN ISO 11607-2/A11:2022 Amendment from Publication date: Jun 2022 Pages: 13 Language: English, French, German Services: Online, Online + Pdf

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.

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Standard from INB
Published: July 1 2020
Effective: July 1 2020
Document type: EN
Pages
ISBN:

ICS: 11.080.30
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 171
European TC: CEN/TC 102
International TC: ISO/TC 198

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: Regulation (EU) 2017/745, Regulation (EU) 2017/746

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Adopted from: ISO 11607-2:2019, IDT
Replaces: SN EN ISO 11607-2:2018

SN EN ISO 11607-2:2020

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