NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 80001-1 ; VDE 0756-1:2023-02 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 13940 | 2016-07 | Health informatics - System of concepts to support continuity of care (ISO 13940:2015); English version EN ISO 13940:2016 More |
| DIN EN ISO 14971 | 2022-04 | Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More |
| DIN EN 60601-1 ; VDE 0750-1:2022-11 | 2022-11 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor1:2006 + Cor2:2007 + A1:2012 + A1:2012/Cor1:2014 + A2:2020); German version EN 60601-1:2006 + Cor.:2010 + A1:2013 + AC:2014 + A1:2013/AC:2014 + A12:2014 + A2:2021 More |
| DIN IEC/TR 80001-2-5 ; VDE 0756-2-5:2016-03 | 2016-03 | Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems (IEC/TR 80001-2-5:2014) More |
| DIN ISO 31000 | 2018-10 | Risk management - Guidelines (ISO 31000:2018) More |
| IEC Guide 120 | 2018-06 | Security aspects - Guidelines for their inclusion in publications 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/TR 80001-2-2 | 2012-07 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls More |
