Abstract
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.
General information
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Status: PublishedPublication date: 2019-02Stage: International Standard published [60.60]
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Edition: 2Number of pages: 44
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Technical Committee :ISO/TC 198ICS :11.080.30
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Life cycle
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Previously
WithdrawnISO 11607-1:2006
WithdrawnISO 11607-1:2006/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
Corrigenda / Amendments
PublishedISO 11607-1:2019/Amd 1:2023
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00
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