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ISO 10993-7:2008 (R2016)
Biological evaluation of medical devices
Part 7: Ethylene oxide sterilization residuals
Part 7: Ethylene oxide sterilization residuals
Preview
Summary
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.
Notes
90.92 : Norme internationale à réviser
Technical characteristics
| Publisher | International Organization for Standardization (ISO) |
| Publication Date | 10/13/2008 |
| Confirmation Date | 11/28/2016 |
| Edition | 2 |
| Page Count | 86 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
Modified by
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13/10/2008
Superseded
, Under review
, Modified
Historical
20/04/2026
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