NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18778 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 20417 | 2021-04 | Medical devices - Information to be supplied by the manufacturer More |
| ISO 80601-2-61 | 2017-12 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 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 14155 | 2021-05 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020 More |
| DIN EN ISO 14159 | 2008-07 | Safety of machinery - Hygiene requirements for the design of machinery (ISO 14159:2002); German version EN ISO 14159:2008 More |
| DIN EN ISO 18562-1 | 2020-05 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017); German version EN ISO 18562-1:2020 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 80601-2-61 | 2019-09 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 80601-2-61:2019 More |
| DIN EN ISO 9000 | 2015-11 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More |
