NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 62366-1 ; VDE 0750-241-1:2021-08 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 60601-1-6 AMD 2 | 2020-07 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability; Amendment 2 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 60601-1-8 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/TR 61258 | 2008-08 | Guidelines for the development and use of medical electrical equipment educational materials More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
| ISO 9001 | 2015-09 | Quality management systems - Requirements More |
