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 |
|---|---|---|
| IEC/TR 80001-2-8 | 2016-05 | Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 More |
| ISO 13940 | 2015-12 | Health informatics - System of concepts to support continuity of care More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 31000 | 2018-02 | Risk management - Guidelines More |
| ISO 81001-1 | 2021-03 | Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts More |
| ISO/IEC Guide 63 | 2019-08 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices More |
| ISO/IEC 20000-1 | 2018-09 | Information technology - Service management - Part 1: Service management system requirements More |
| ISO/IEC/IEEE 15026-1 | 2019-03 | Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary More |
| ISO/IEC/IEEE 16085 | 2021-01 | Systems and software engineering - Life cycle processes - Risk management More |
| ISO/TR 80001-2-6 | 2014-12 | Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements More |
