DS/EN ISO 10993-7/A1
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)
active, Most Current
| Organization: | DS |
| Publication Date: | 17 January 2022 |
| Status: | active |
| Page Count: | 16 |
| 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
DS/EN ISO 10993-7/A1
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...
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...