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ISO 7554-3:2026 Surgical instruments — Terms, measuring methods and test methods — Part 3: Test methods

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ISO 41002:2026 Facility management — Development of the facility management organization

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ISO 39004:2026 Road traffic safety — Good practice for service providers using digital platform

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ISO 20405:2018

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

CDN $192.00

SKU: d0b6a23303ab Categories: ,

Description

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.

Edition

1

Published Date

2018-05-18

Status

PUBLISHED

Pages

16

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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.

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