ISO 11607-2:2019
2019-02
Abstract
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.
General information
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Status: PublishedPublication date: 2019-02Stage: Close of review [90.60]
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Edition: 2Number of pages: 13
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Technical Committee :ISO/TC 198ICS :11.080.30
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Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Life cycle
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Previously
WithdrawnISO 11607-2:2006
WithdrawnISO 11607-2:2006/Amd 1:2014
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.PublishedISO 11607-2:2019/Amd 1:2023
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00
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