ISO TR 17791:2013 ED1

Health informatics -- Guidance on standards for enabling safety in health software ISO TR 17791:2013 ED1

Publication date:   Dec 5, 2013

General information

60.60 Standard published   Feb 28, 2014

IEC

TC 62/SC 62A

Technical Report

35.240.80   IT applications in health care technology

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Scope

ISO/TR 17791:2013 provides guidance to National Member Bodies (NMBs) and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software. The framework presented in ISO/TR 17991:2013, together with the mapping of standards to the framework, illustrate relevant standards and how they can optimally be applied. The mapping works to clearly demonstrate where standards gaps and overlaps exist. Specifically, ISO/TR 17791:2013: - identifies a coherent set of international standards that promote the patient-safe (or safer) development, implementation and use of health software, - provides guidance on the applicability of these standards towards enabling optimal safety in health software within overall risk management and quality management approaches, as well as within the lifecycle steps and processes of health software development, - addresses the health software safety issues that remain, either as gaps or overlaps between or among the identified standards, and - discusses how those gaps and overlaps could be addressed?in the short or long term?through revision of the current standards or the development of new ones. Harm to the operators of health software, should any such risk exist, is outside the scope of ISO/TR 17791:2013.

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PUBLISHED
ISO TR 17791:2013 ED1
60.60 Standard published
Feb 28, 2014