Standard Swedish standard · SS-EN ISO 11607-2:2020/A1:2023

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)

Status: Valid

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Standard Swedish standard · SS-EN ISO 11607-2:2020/A1:2023

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)
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Scope
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.

Subjects

Sterilized packaging (11.080.30)


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Standard Swedish standard · SS-EN ISO 11607-2:2020/A1:2023

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)
Subscribe on standards - Read more Dölj
Price: 1 097 SEK
standard ikon pdf

PDF

Price: 1 097 SEK
standard ikon

Paper

Price: 1 755,20 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80047547

Edition: 1

Approved: 12/4/2023

No of pages: 28

Amendment: SS-EN ISO 11607-2:2020