NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13485 [Withdrawn] referenced in following documents:
| Document number | Edition | Title |
|---|---|---|
| VDI 2017 | 2019-07 | Medical Grade Plastics (MGP) More |
| VDI 5701 | 2018-05 | Biomaterials in medicine - Classification, requirements, and applications More |
| VDI 5702 Blatt 1 | 2017-04 | Medical device software - Medical SPICE Process assessment model More |
| VDI/VDE 2426 Blatt 1 | 2019-06 | Catalogues in maintenance and management of medical devices - Fundamentals More |
| DIN EN ISO 10993-1 | 2021-05 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More |
| DIN EN ISO 11135 | 2020-04 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More |
| DIN EN ISO 11137-3 | 2017-11 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More |
| DIN EN ISO 11138-1 | 2017-07 | Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017 More |
| DIN EN ISO 11138-7 | 2019-11 | Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019); German version EN ISO 11138-7:2019 More |
| DIN EN ISO 11737-2 | 2020-07 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020 More |
