ISO 10993-7:2008
2008-10
Abstract
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
General information
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Status: PublishedPublication date: 2008-10Stage: International Standard to be revised [90.92]
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Edition: 2Number of pages: 86
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Technical Committee :ISO/TC 194ICS :11.100.20
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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.
Next version under development
ISO/DIS 10993-7
ISO/DIS 10993-7
Biological evaluation of medical devices
Part 7: Ethylene oxide sterilization residuals
Life cycle
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Previously
WithdrawnISO 10993-7:1995
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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
Correct the current edition; free; not included in the text of the existing standard.PublishedISO 10993-7:2008/Cor 1:2009
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.PublishedISO 10993-7:2008/Amd 1:2019
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00
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Will be replaced by
Under developmentISO/DIS 10993-7
