NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-7 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More |
| ISO 10993-10 | 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization More |
| ISO 10993-12 | 2021-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials More |
| ISO 10993-3 | 2014-10 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 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 10993-12 | 2021-08 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021 More |
| DIN EN ISO 10993-3 | 2015-02 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014 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 |
| 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 |
