Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Also Known As:
SKU153568964
Published by
International Organization for Standardization
ISO
Publication Date2008-10
Pages CountPages94
ISO 10993-7:2008 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 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 ISO 10993-7:2008.
Details
| Edition | 2 |
| ICS Codes | 11.100.20 - Biological evaluation of medical devices |
| Language(s) | English |
| File Size | 1.9 MB |
Purchase
Right after completing the purchase process, you will immediately get a digital copy of this standard which is:
Not Locked
Printable
Multi-User
$
45.50
