NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 7198 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11137-1 AMD 1 | 2013-07 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1 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 |
| 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 10993-5 | 2009-10 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009 More |
| DIN EN ISO 14630 | 2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012); German version EN ISO 14630:2012 More |
| DIN EN ISO 14937 | 2010-03 | 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 (ISO 14937:2009); German version EN ISO 14937:2009 More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
