NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13408-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 61882 | 2016-03 | Hazard and operability studies (HAZOP studies) - Application guide More |
| ISO 10993-17 | 2023-09 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents More |
| ISO 11135 | 2014-07 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More |
| ISO 11137-2 | 2013-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More |
| ISO 11137-2 AMD 1 | 2022-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Amendment 1 More |
| ISO 11137-3 | 2017-06 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control More |
| ISO 11139 | 2018-08 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More |
| ISO 11607-1 | 2019-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More |
| ISO 11607-2 | 2019-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes More |
| ISO 11737-3 | 2023-06 | Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing More |
