ISO-10993-7 › Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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Included in this current edition are the following subparts:
2ND EDITION CORRIGENDUM 1 - Nov. 15, 2009
FOR 2ND EDITION AMENDMENT 1 SEE - Dec. 1, 2019
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.
To find similar documents by classification:
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