UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

BSI - PD ISO/TR 24971 - TC

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

inactive
Organization: BSI
Publication Date: 24 June 2020
Status: inactive
Page Count: 198
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 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...
View Less
View All
Advertisement