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ISO/TS 20405:2018

Health informatics - Framework of event data and reporting definitions for the safety of health software
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ISO/TS 20405:2018

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

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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.

SDO ISO: International Organization for Standardization
Document Number ISO/TS 20405
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 215
Publish Date Document Id Type View
Not Available ISO/TS 20405:2018 Revision