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BSI - BS PD CEN ISO/TR 24971-TC

Tracked Changes (Redline) - Medical devices – Guidance on the application of ISO 14971

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Organization: BSI
Publication Date: 14 August 2020
Status: active
Page Count: 214
ICS Code (Medical equipment in general): 11.040.01

Document History

BS PD CEN ISO/TR 24971-TC
August 14, 2020
Tracked Changes (Redline) - Medical devices – Guidance on the application of ISO 14971
A description is not available for this item.
PD ISO/TR 24971 - TC
June 24, 2020
Tracked Changes (Redline) - Medical devices – Guidance on the application of ISO 14971
A description is not available for this item.

References

This document references:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
This document references:
IEC 60601-1-8 - Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Published by IEC on July 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
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 61326-2-6 - Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
Published by IEC on October 1, 2020
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL...
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