Standard Swedish standard · SS-EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

Status: Withdrawn

· Replaced by: SS-EN ISO 11607-1:2018 , SS-EN ISO 11607-1:2020 Amended by: SS-EN ISO 11607-1:2009/A1:2014
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Standard Swedish standard · SS-EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
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Scope
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture

Subjects

Sterilized packaging (11.080.30) Packaging materials and accessories (55.040) Paper and board (85.060)


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Standard Swedish standard · SS-EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
Subscribe on standards - Read more Dölj
Price: 2 027 SEK
standard ikon pdf

PDF

Price: 2 027 SEK
standard ikon

Paper

Price: 3 243,20 SEK
standard ikon pdf + standard ikon

PDF + paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-70027

Edition: 2

Approved: 6/15/2009

No of pages: 40

Replaces: SS-EN ISO 11607-1:2006

Replaced by: SS-EN ISO 11607-1:2018 , SS-EN ISO 11607-1:2020