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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 October 2013
Status: inactive
Page Count: 126
ICS Code (Medical equipment): 11.040
scope:

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 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 and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).

Document History

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.
IEC 60601-1-6
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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