NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11139 [New] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO/TS 11137-4 | 2020-06 | Sterilization of health care products - Radiation - Part 4: Guidance on process control More |
| ISO/TS 16775 | 2021-11 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 More |
| ISO/TS 19930 | 2017-12 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10⁻⁶ More |
| ISO/TS 21387 | 2020-09 | Sterilization of medical devices - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release More |
| ISO/TS 22421 | 2021-01 | Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities More |
| prEN 17180 | 2023-02 | Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing More |
