NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 81001-5-1 ; VDE 0750-103-5-1:2023-07 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 62740 | 2015-02 | Root cause analysis (RCA) More |
| IEC 81001-5-1 | 2021-12 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle More |
| IEC 82304-1 | 2016-10 | Health software - Part 1: General requirements for product safety More |
| IEC 82304-1 | 2016-10 | Health software - Part 1: General requirements for product safety More |
| IEC/TR 60601-4-5 | 2021-01 | Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications More |
| IEC/TR 63069 | 2019-05 | Industrial-process measurement, control and automation - Framework for functional safety and security 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 |
| 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 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
