NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-1-10 ; VDE 0750-1-10:2021-11 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
| DIN EN ISO 14001 | 2015-11 | Environmental management systems - Requirements with guidance for use (ISO 14001:2015); German and English version EN ISO 14001:2015 More |
| DIN EN ISO 14040 | 2021-02 | Environmental management - Life cycle assessment - Principles and framework (ISO 14040:2006 + Amd 1:2020); German version EN ISO 14040:2006 + A1:2020 More |
| DIN EN ISO 9000 | 2015-11 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More |
| DIN EN 60601-1-6 ; VDE 0750-1-6:2021-11 | 2021-11 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + A1:2013 + A2:2020); German version EN 60601-1-6:2010 + A1:2015 + A2:2021 More |
| DIN EN 62304 ; VDE 0750-101:2016-10 | 2016-10 | Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015 More |
| DIN EN 62366-1 ; VDE 0750-241-1:2021-08 | 2021-08 | Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020 More |
| DIN 820-12 | 2014-06 | Standardization - Part 12: Guidelines for the inclusion of safety aspects in standards (ISO/IEC Guide 51:2014) More |
