NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18562-1 [Pre-order] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 10993-9 | 2022-03 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021 More |
| DIN EN ISO 13485 | 2021-12 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021 More |
| 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 18562-2 | 2025-02 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024); German version EN ISO 18562-2:2024 More |
| DIN EN ISO 18562-3 | 2025-02 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024); German version EN ISO 18562-3:2024 More |
| DIN EN ISO 18562-4 | 2025-02 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024); German version EN ISO 18562-4:2024 More |
| DIN EN ISO 20417 | 2022-03 | Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021 More |
| DIN EN ISO 4135 | 2022-06 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022); Trilingual version EN ISO 4135:2022 More |
| DIN EN ISO/IEC 17025 | 2018-03 | General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 More |
| DIN EN 60601-1 ; VDE 0750-1:2022-11 | 2022-11 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor1:2006 + Cor2:2007 + A1:2012 + A1:2012/Cor1:2014 + A2:2020); German version EN 60601-1:2006 + Cor.:2010 + A1:2013 + AC:2014 + A1:2013/AC:2014 + A12:2014 + A2:2021 More |
