UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

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

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

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

CENELEC - EN 60601-1-6

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

active, Most Current
Organization: CENELEC
Publication Date: 1 April 2010
Status: active
Page Count: 34
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

EN 60601-1-6
April 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...
April 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...
July 1, 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...
July 1, 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.
November 1, 2004
Medical electrical equipment Part 1-6: General requirements for safety Collateral standard: Usability
A description is not available for this item.

References

Advertisement