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BSI - BS PD IEC/TR 80002-1

Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software

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Organization: BSI
Publication Date: 31 May 2010
Status: active
Page Count: 68
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01

Document History

BS PD IEC/TR 80002-1
May 31, 2010
Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software
A description is not available for this item.

References

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 references:
IEC 60812 - Failure modes and effects analysis (FMEA and FMECA)
Published by IEC on August 1, 2018
This document explains how failure modes and effects analysis (FMEA), including the failure modes, effects and criticality analysis (FMECA) variant, is planned, performed, documented and maintained....
This document references:
IEC 61025 - Fault Tree Analysis (FTA)
Published by IEC on December 1, 2006
This International Standard describes fault tree analysis and provides guidance on its application as follows: – definition of basic principles; - describing and explaining the associated...
This document references:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document is referenced by:
AAMI SW91 - Classification of defects in health software
Published by AAMI on January 1, 2018
This document identifies a defect classification system, or taxonomy, that can be used to classify the types of defects that might exist in software. The taxonomy applies to defect root causes in all...
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