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ISO/TS 20405:2018

Current
Current

The latest, up-to-date edition.

Health informatics Framework of event data and reporting definitions for the safety of health software
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

18-05-2018

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.

DocumentType
Technical Specification
Pages
16
PublisherName
International Organization for Standardization
Status
Current

Standards Relationship
PD ISO/TS 20405:2018 Identical

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
ISO 31000:2009 Risk management Principles and guidelines
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO/IEC 27005:2011 Information technology Security techniques Information security risk management
ISO/TR 17791:2013 Health informatics Guidance on standards for enabling safety in health software
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO/TS 25238:2007 Health informatics Classification of safety risks from health software
ISO Guide 73:2009 Risk management — Vocabulary

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