NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18562-4 [Pre-order] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 14971 | 2022-04 | Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More |
| DIN EN ISO 18562-1 | 2025-02 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024); German version EN ISO 18562-1:2024 More |
| ISO 10993-11 | 2017-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More |
| 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 10993-15 | 2019-11 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys More |
| ISO 10993-16 | 2017-05 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables More |
| ISO 10993-2 | 2022-11 | Biological evaluation of medical devices - Part 2: Animal welfare requirements More |
| ISO 10993-3 | 2014-10 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More |
| ISO 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More |
