Standard Swedish standard · SS-EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

Status: Valid

· Amended by: SS-EN ISO 11607-1:2020/A11:2022 , SS-EN ISO 11607-1:2020/A1:2023
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Standard Swedish standard · SS-EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
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Scope
This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

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 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Subscribe on standards - Read more Dölj
Price: 3 309 SEK
standard ikon pdf

PDF

Price: 3 309 SEK
standard ikon

Paper

Price: 5 294,40 SEK
standard ikon pdf + standard ikon

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80019289

Edition: 4

Approved: 1/20/2020

No of pages: 56

Replaces: SS-EN ISO 11607-1:2009 , SS-EN ISO 11607-1:2009/A1:2014 , SS-EN ISO 11607-1:2018