ISO/TR 17791:2013
Current
The latest, up-to-date edition.
Health informatics Guidance on standards for enabling safety in health software
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
12-05-2013
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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.
| DocumentType |
Technical Report
|
| Pages |
47
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| PD ISO/TR 17791:2013 | Identical |
| NEN NPR ISO/TR 17791 : 2013 | Identical |
| I.S. EN 82304-1:2017 | HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| EN 82304-1:2017 | Health Software - Part 1: General requirements for product safety |
| 14/30304350 DC : 0 | BS EN ISO 27799 - HEALTH INFORMATICS - INFORMATION SECURITY MANAGEMENT IN HEALTH USING ISO/IEC 27002 |
| BS EN 82304-1:2017 | Health Software General requirements for product safety |
| BS EN ISO 27799:2008 | Health informatics. Information security management in health using ISO/IEC 27002 |
| GS ISI 001-2 : 1.1.2 | INFORMATION SECURITY INDICATORS (ISI); INDICATORS (INC); PART 2: GUIDE TO SELECT OPERATIONAL INDICATORS BASED ON THE FULL SET GIVEN IN PART 1 |
| ISO/TS 20405:2018 | Health informatics Framework of event data and reporting definitions for the safety of health software |
| EN ISO 27799:2016 | Health informatics - Information security management in health using ISO/IEC 27002 (ISO 27799:2016) |
| 15/30246774 DC : 0 | BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| BS IEC 82304-1 : 2016 | HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
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