NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 21649 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| ISO 11201 | 2010-05 | Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections More |
| ISO 11202 | 2010-05 | Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections More |
| ISO 11204 | 2010-05 | Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions applying accurate environmental corrections More |
| ISO 14155 | 2020-07 | Clinical investigation of medical devices for human subjects - Good clinical practice More |
| ASTM F 1980 | 2021 | Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices More |
| DIN EN IEC 61000-4-3 ; VDE 0847-4-3:2021-11 | 2021-11 | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test (IEC 61000-4-3:2020); German version EN IEC 61000-4-3:2020 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 10993-10 | 2023-04 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023 More |
| DIN EN ISO 10993-11 | 2018-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018 More |
