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BSI - BS EN 60601-1-6

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

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Organization: BSI
Publication Date: 30 November 2007
Status: inactive
Page Count: 78
ICS Code (Medical equipment in general): 11.040.01
scope:

This International Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This collateral standard addresses NORMAL USE and USE ERRORS but excludes ABNORMAL USE.

Document History

BS EN 60601-1-6
May 31, 2010
Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
A description is not available for this item.
BS EN 60601-1-6 + A2
May 31, 2010
Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
A description is not available for this item.
BS EN 60601-1-6
May 31, 2010
Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
A description is not available for this item.
BS EN 60601-1-6
November 30, 2007
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
A description is not available for this item.
BS EN 60601-1-6
November 30, 2007
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
This International Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL...
BS EN 60601-1-6
November 17, 2004
Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
A description is not available for this item.
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References

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:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...

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