NA 176
DIN Standards Committee Health Technologies
DIN EN 14683 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| EN ISO 10993-1 | 2020-12 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10) More |
| EN ISO 11737-1 | 2018-01 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) More |
| ISO 22609 | 2004-12 | Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) More |
| EN ISO 10993-10 | 2023-02 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021) More |
| EN ISO 10993-11 | 2018-05 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017) More |
| EN ISO 10993-12 | 2021-06 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) More |
| EN ISO 10993-13 | 2010-06 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) More |
| EN ISO 10993-14 | 2009-04 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) More |
| EN ISO 10993-15 | 2023-05 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) More |
| EN ISO 10993-16 | 2017-12 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017) More |
