NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18778 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60601-1-8 | 2006-10 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems More |
| IEC 60601-1-8 AMD 1 | 2012-11 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; Amendment 1 More |
| IEC 60601-1-8 AMD 2 | 2020-07 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; Amendment 2 More |
| IEC 60601-2-27 | 2011-03 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| IEC 62366-1 AMD 1 | 2020-06 | Medical devices - Part 1: Application of usability engineering to medical devices; Amendment 1 More |
| IEC 62570 | 2014-02 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment More |
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More |
| ISO 14155 | 2020-07 | Clinical investigation of medical devices for human subjects - Good clinical practice More |
| ISO 17664-2 | 2021-02 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices More |
