DS/EN ISO 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
active, Most Current
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| Organization: | DS |
| Publication Date: | 15 December 2008 |
| Status: | active |
| Page Count: | 101 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993. NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).
Document History
January 17, 2022
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals – Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
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...
November 30, 2009
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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...
DS/EN ISO 10993-7
December 15, 2008
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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...
January 17, 1996
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization rediduals
This part of the standard specifies allowable limits for residual limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in ethylene oxide-sterilized medical devices.
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals – Amendment 1 (ISO 10993-7/FDAM 1:2019)
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...
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals – Amendment 1 (ISO 10993-7/DAM 1:2018)
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...
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/FDIS 10993-7:2008)
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...
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