ISO/TS 20405:2018
Current
The latest, up-to-date edition.
Health informatics Framework of event data and reporting definitions for the safety of health software
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
18-05-2018
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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.
| 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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