DIN EN ISO 10079-4 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60601-1 | 2005-12 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More |
| IEC 60601-1 AMD 1 | 2012-07 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 1 More |
| IEC 60601-1 AMD 2 | 2020-08 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 2 More |
| EN 15986 | 2011-03 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates More |
| IEC 61672-1 | 2013-09 | Electroacoustics - Sound level meters - Part 1: Specifications More |
| IEC 80369-5 | 2016-03 | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications 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 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 20417 | 2021-04 | Medical devices - Information to be supplied by the manufacturer More |
