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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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 / Amendments
PublishedISO 10993-7:2008/Amd 1:2019
PublishedISO 10993-7:2008/Cor 1:2009
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00
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Will be replaced by
Under developmentISO/CD 10993-7.2
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