ISO-10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

ISO-10993-7 - 2ND EDITION - CURRENT
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 2ND EDITION - Oct. 15, 2008
 2ND EDITION CORRIGENDUM 1 - Nov. 15, 2009

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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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO 10993-7:2008

Revision Level

2ND EDITION

Status

Current

Publication Date

Oct. 15, 2008

Committee Number

ISO/TC 194