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ISO/DIS 10993-7

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Note: Latest version: ISO 10993-7:2008

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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.

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Standard from ISO
Period for objection until: August 26 2024
Edition: 3
Document type: IS
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ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.20
International TC: ISO/TC 194

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Revises: ISO 10993-7:2008

ISO/DIS 10993-7

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ISO 10993-7:2008

ISO 10993-7:1995

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ISO 10993-7:2008

ISO 10993-7:1995

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