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About This Item
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
Document History
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BS EN ISO 10993-7:2008+A1:2022
viewing
Biological evaluation of medical devices-Ethylene oxide sterilization residuals- Most Recent
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BS EN ISO 10993-7:2008
Biological evaluation of medical devices-Ethylene oxide sterilization residuals- Historical Version
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BS 06/30097290 DC
ISO 10993-7. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals- Historical Version
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BS EN ISO 10993-7:1996
Biological evaluation of medical devices-Ethylene oxide sterilization residuals- Historical Version