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DIN EN IEC 81001-5-1 ; VDE 0750-103-5-1:2023-07
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (IEC 81001-5-1:2021); German version EN IEC 81001-5-1:2022
Edition
2023-07
DIN EN IEC 80001-1 ; VDE 0756-1:2023-02
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (IEC 80001-1:2021); German version EN IEC 80001-1:2021
Edition
2023-02
DIN EN 82304-1 ; VDE 0750-102-1:2018-04
Health Software - Part 1: General requirements for product safety (IEC 82304-1:2016); German version EN 82304-1:2017
Edition
2018-04
DIN CEN ISO/TS 82304-2
Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021); German version CEN ISO/TS 82304-2:2021
Edition
2022-04
DIN EN ISO 27799
Health informatics - Information security controls in health based on ISO/IEC 27002 (ISO 27799:2025); English version EN ISO 27799:2026
Edition
2026-03
OVE EN IEC 81001-5-1
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (german version)
Edition
2023-08-01
SN EN 82304-1
Health Software - Part 1: General requirements for product safety
Edition
2017-09
NF C74-055-1 ; NF EN 82304-1:2017-09-01
Health Software - Part 1: general requirements for product safety
Edition
2017-09-01
IEC 82304-1
Health software - Part 1: General requirements for product safety
Edition
2016-10
ISO/TS 82304-2
Health software - Part 2: Health and wellness apps - Quality and reliability
Edition
2021-07