SS-EN ISO 10993-7:2008/A1:2022
Current
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)
Hardcopy
English
01-19-2022
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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