NEN-EN-ISO 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
inactive
| Organization: | NEN |
| Publication Date: | 1 February 2006 |
| Status: | inactive |
| Page Count: | 98 |
| 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 and guidance and a flowchart showing how the standard is applied are also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.
Document History
February 1, 2022
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 1, 2009
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
A description is not available for this item.
November 1, 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...
NEN-EN-ISO 10993-7
February 1, 2006
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...
November 1, 1995
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies, in section 2, the allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilize medical devices. Section 3 gives...