NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 80601-2-12 ; VDE 0750-2-12:2020-07 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60601-1-2 | 2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests More |
| IEC 60601-1-6 | 2010-01 | Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability More |
| IEC 60601-1-6 AMD 1 | 2013-10 | Amendment 1 to IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability More |
| 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 60601-2-2 | 2017-03 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories More |
| IEC 61672-1 | 2013-09 | Electroacoustics - Sound level meters - Part 1: Specifications More |
| IEC 62304 | 2006-05 | Medical device software - Software life cycle processes More |
| IEC 62304 AMD 1 | 2015-06 | Medical device software - Software life cycle processes More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
