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

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

Status: Withdrawn

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

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


Buy this standard

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

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Subscribe on standards - Read more Dölj
Price: 1 378 SEK
standard ikon pdf

PDF

Price: 1 378 SEK
standard ikon

Paper

Price: 2 204,80 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-45216

Edition: 1

Approved: 4/27/2006

No of pages: 17

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