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Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts

Abstract

This document provides the foundational principles, concepts, and terminology for health software and health IT systems. It addresses safety, effectiveness, and security across the full lifecycle, from concept to disposal, and considers the evolving internal and external context, including people, technology, organization, processes, and the external environment.

Begin

2025-12-18

Planned document number

DIN ISO 81001-1

Project number

02233565

Responsible national committee

DKE/UK 811.3 - Sicherheit von medizinisch genutzten Geräten/Systemen/Einrichtungen in der vernetzten Anwendung  

Contact

Dorina Laurila-Epe

Merianstr. 28
63069 Offenbach am Main

Tel.: +49 69 6308-295

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