NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18562-1 [Pre-order] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More |
| ISO 10993-17 | 2023-09 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 18562-2 | 2024-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter More |
| ISO 18562-3 | 2024-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances More |
| ISO 18562-4 | 2024-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate More |
| BS 5724-3.12 | 1991-11-29 | Medical electrical equipment. Particular requirements for performance. Method of declaring parameters for lung ventilators More |
| DIN EN ISO 10993-1 | 2021-05 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More |
| DIN EN ISO 10993-17 | 2024-02 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023 More |
| DIN EN ISO 10993-18 | 2023-11 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023 More |
