ISO 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
active, Most Current
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| Organization: | ISO |
| Publication Date: | 15 October 2008 |
| Status: | active |
| Page Count: | 94 |
| 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
December 1, 2019
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals AMENDMENT 1: Applicability of allowable limits for neonates and infants
A description is not available for this item.
November 15, 2009
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals TECHNICAL CORRIGENDUM 1
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...
ISO 10993-7
October 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 1, 1995
Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals; (CEN EN ISO 10993-7: 1995)
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...