Standard Swedish standard · SS-EN ISO 11607-2:2006/A1:2014

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)

Status: Withdrawn

· Replaced by: SS-EN ISO 11607-2:2018 , SS-EN ISO 11607-2:2020
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Standard Swedish standard · SS-EN ISO 11607-2:2006/A1:2014

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
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Scope

ISO 11607-2:2006 specifies the requirements for 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. ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Subjects

Sterilized packaging (11.080.30)


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Standard Swedish standard · SS-EN ISO 11607-2:2006/A1:2014

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
Subscribe on standards - Read more Dölj
Price: 503 SEK
standard ikon pdf

PDF

Price: 503 SEK
standard ikon

Paper

Price: 804,80 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-102476

Edition: 1

Approved: 7/24/2014

No of pages: 8

Amendment: SS-EN ISO 11607-2:2006

Replaced by: SS-EN ISO 11607-2:2018 , SS-EN ISO 11607-2:2020