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SS-EN ISO 10993-7:2008/A1:2022

Current

Current

The latest, up-to-date edition.

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)

Available format(s)

Hardcopy

Language(s)

English

Published date

19-01-2022

€107.01
Excluding VAT

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.

Committee
TC 194
DocumentType
Amendment
Pages
16
PublisherName
Standardiserings-Kommissionen I Sverige
Status
Current

Standards Relationship
EN ISO 10993-7:2008+A1:2022 Identical

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