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

Biological evaluation of medical devices-Ethylene oxide sterilization residuals

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

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Full Description

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

Product Details

Published:: 01/26/2022
ISBN(s):: 9780580971808
Number of Pages:: 98
File Size:: 1 file , 4.7 MB
Product Code(s):: 30355037, 30355037, 30355037
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