ISO 11607-1:2006
2006-04
Abstract
ISO 11607-1:2006 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.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 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.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.
General information
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Status: WithdrawnPublication date: 2006-04Stage: Withdrawal of International Standard [95.99]
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Edition: 1Number of pages: 24
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Technical Committee :ISO/TC 198ICS :11.080.30
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Life cycle
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Previously
WithdrawnISO 11607:2003
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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.WithdrawnISO 11607-1:2006/Amd 1:2014
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00
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Revised by
PublishedISO 11607-1:2019
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