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ISO/TS 20405:2018

Health informatics — Framework of event data and reporting definitions for the safety of health software

May 18, 2018

General information

90.93     Feb 16, 2022

ISO

ISO/TC 215

Technical Specification

35.240.80  

English  

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Scope

This document provides a model framework for improving the surveillance and reporting of events with respect to the safety of health software.
This document defines those data elements needed for identification of particular events including incidents, near-misses and unsafe conditions, as well as outlining good principles, relevant concepts and a process model for the recording, analysis and reporting of event-specific information related to the safety of health software.

Life cycle

NOW

PUBLISHED
ISO/TS 20405:2018
90.93 Standard confirmed
Feb 16, 2022

National adoptions

DS ISO/TS 20405:2018  
DPS

Health informatics — Framework of event data and reporting definitions for the safety of health software

60.60 Standard published

DPS/KT 224 more

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