NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 22442-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-3 | 2014-10 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More |
| ISO 10993-4 | 2017-04 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More |
| ISO 10993-5 | 2009-06 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity More |
| ISO 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 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 11135 AMD 1 | 2018-10 | Revision of Annex E, Single batch release More |
| ISO 11137-2 | 2013-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose 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 11737-1 | 2018-01 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products More |
| ISO 11737-1 AMD 1 | 2021-05 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products; Amendment 1 More |
