SS-EN ISO 10993-7:2008/A1:2022
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Biological evaluation of medical devices - Part 7: Residues from ethylene oxide sterilisation - Appendix 1: Application of permissible limits for newborns and infants (ISO 10993-7:2008/Amd 1:2019)
Amendment of
Available format(s)
Hardcopy
Language(s)
English
Published date
19-01-2022
Publisher
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.
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