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IEC 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: IEC
Publication Date: 1 July 2020
Status: active
Page Count: 100
ICS Code (Medical equipment in general): 11.040.01
scope:

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.

NOTE Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.

Document History

IEC 60601-1-6
July 1, 2020
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
July 1, 2020
AMENDMENT 2 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.
October 1, 2013
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
October 1, 2013
AMENDMENT 1 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.
January 1, 2010
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
December 1, 2006
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...
June 1, 2004
Medical electrical equipment – Part 1-6: General requirements for safety – Collateral Standard: Usability
This Collateral Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to SAFETY of MEDICAL ELECTRICAL EQUIPMENT, hereinafter referred to...

References

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