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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

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

Health Software - Part 1: General requirements for product safety (IEC 82304-1:2016); German version EN 82304-1:2017
Edition 2018-04

Technical Specification

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

Standards [New]

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

Standards [CURRENT]

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

Standards [CURRENT]

SN EN 82304-1

Health Software - Part 1: General requirements for product safety
Edition 2017-09

Health Software - Part 1: general requirements for product safety
Edition 2017-09-01

Standards [CURRENT]

IEC 82304-1

Health software - Part 1: General requirements for product safety
Edition 2016-10

Pre-standard

ISO/TS 82304-2

Health software - Part 2: Health and wellness apps - Quality and reliability
Edition 2021-07

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