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Project

Health software and health IT systems safety, effectiveness and security - Part 4-1: Application of risk management in the Implementation and Clinical Use.

Begin

2026-02-04

Planned document number

ISO/CD 81001-4-1

Responsible national committee

DKE/UK 804.3 - Sicherheit von medizinisch genutzten Geräten/Systemen/Einrichtungen in der vernetzten Anwendung  

Responsible international committee

ISO/TC 215/JWG 7 - Joint ISO/TC 215 - IEC/SC 62A WG: Safe, effective and secure health software and health IT systems, including those incorporating medical devices  

previous edition(s)

Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management
2021-09

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