NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 7198 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-13 | 2010-06 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More |
| ISO 10993-14 | 2001-11 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More |
| 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 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 14937 | 2009-10 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices More |
| DIN EN ISO 10993-13 | 2010-11 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010 More |
| DIN EN ISO 10993-14 | 2009-08 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 More |
