NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 80601-2-80 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC Guide 115 | 2023-04 | Application of measurement uncertainty to conformity assessment activities in the electrotechnical sector More |
| 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 |
| IEC 61672-1 | 2013-09 | Electroacoustics - Sound level meters - Part 1: Specifications 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 |
| IEC 81001-5-1 | 2021-12 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle More |
| ISO 14937 | 2009-10 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices More |
