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BS EN ISO 10993-7:2008+A1:2022

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BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices

standard by British Standard / European Standard / International Organization for Standardization, 01/26/2022

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This part of ISO 10993 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 this document is applied, are also included in the informative annexes.

Incorporates the following:
BS EN ISO 10993-7:2008

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Published: 01/26/2022 ISBN(s): 9780580971808 Number of Pages: 98 File Size: 1 file , 4.7 MB Product Code(s): 30355037, 30355037, 30355037 Note: This product is unavailable in Belarus, Russia, Ukraine