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 10993-6 | 2016-12 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation More |
| ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More |
| ISO 10993-7 Technical Corrigendum 1 | 2009-11 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1 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 11137-1 | 2006-04 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More |
