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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 |
|---|---|---|
| AAMI TIR 57 | 2016 | Principles for medical device security - Risk management More |
| AAMI TIR 97 | 2019 | Principles for medical device security - Postmarket risk management for device manufacturers More |
| DIN CEN ISO/TS 14441 ; DIN SPEC 58996:2014-04 | 2014-04 | Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment (ISO/TS 14441:2013); German version CEN ISO/TS 14441:2013 More |
| DIN CLC IEC/TR 63069 ; VDE 0802-69:2021-05 | 2021-05 | Industrial-process measurement, control and automation - Framework for functional safety and security (IEC/TR 63069:2019); German version CLC IEC/TR 63069:2020 More |
| DIN EN IEC 62443-3-2 ; VDE 0802-3-2:2021-12 | 2021-12 | Security for industrial automation and control systems - Part 3-2: Security risk assessment for system design (IEC 62443-3-2:2020); German version EN IEC 62443-3-2:2020 More |
| DIN EN IEC 62443-3-3 ; VDE 0802-3-3:2020-01 | 2020-01 | Industrial communication networks - Network and system security - Part 3-3: System security requirements and security levels (IEC 62443-3-3:2013 + COR1:2014); German version EN IEC 62443-3-3:2019 + AC:2019 More |
| DIN EN IEC 62443-4-1 ; VDE 0802-4-1:2018-10 | 2018-10 | Security for industrial automation and control systems - Part 4-1: Secure product development lifecycle requirements (IEC 62443-4-1:2018); German version EN IEC 62443-4-1:2018 More |
| DIN EN IEC 62443-4-2 ; VDE 0802-4-2:2019-12 | 2019-12 | Security for industrial automation and control systems - Part 4-2: Technical security requirements for IACS components (IEC 62443-4-2:2019); German version EN IEC 62443-4-2:2019 More |
| DIN EN ISO 13485 | 2021-12 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021 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 |
