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CENELEC - EN 62366

Medical devices - Application of usability engineering to medical devices

inactive, Most Current
Organization: CENELEC
Publication Date: 1 January 2008
Status: inactive
Page Count: 108
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 SAFETY of a MEDICAL DEVICE. 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.

NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE.

If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2).

This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.

Document History

EN 62366
January 1, 2008
Medical devices - Application of usability engineering to medical devices
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING...
January 1, 2008
Medical devices - Application of usability engineering to medical devices
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING...

References

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