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BSI - BS PD ISO/TR 27809

Health informatics - Measures for ensuring patient safety of health software

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Organization: BSI
Publication Date: 31 August 2007
Status: active
Page Count: 48
ICS Code (IT applications in health care technology): 35.240.80

Document History

BS PD ISO/TR 27809
August 31, 2007
Health informatics - Measures for ensuring patient safety of health software
A description is not available for this item.

References

This document references:
CEN/TS 15260 - Health informatics - Classification of safety risks from health informatics products
Published by CEN on March 1, 2006
A description is not available for this item.
This document references:
IEC 61508-5 - Functional safety of electrical/electronic/programmable electronic safety-related systems – Part 5: Examples of methods for the determination of safety integrity levels
Published by IEC on April 1, 2010
This part of IEC 61508 provides information on – the underlying concepts of risk and the relationship of risk to safety integrity (see Annex A); – a number of methods that will enable the safety...
This document references:
IEC 61508-3 - Functional safety of electrical/electronic/programmable electronic safety-related systems – Part 3: Software requirements
Published by IEC on April 1, 2010
This part of the IEC 61508 series a) is intended to be utilized only after a thorough understanding of IEC 61508-1 and IEC 61508-2; b) applies to any software forming part of a safety-related system...
This document references:
IEC 62304 - Medical device software – Software life cycle processes
Published by IEC on June 1, 2015
Purpose This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for...
This document is referenced by:
BS ISO/IEC/IEEE 15026-1 - Systems and software engineering - Systems and software assurance Part 1: Concepts and vocabulary
Published by BSI on March 31, 2019
A description is not available for this item.
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