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BS EN ISO 10993-7:2008+A1:2022
M00004382
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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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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