UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
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

Finish!
Privacy Policy

This is embarrasing...

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

IEC 62366

Medical devices – Application of usability engineering to medical devices

inactive
Buy Now
Organization: IEC
Publication Date: 1 October 2007
Status: inactive
Page Count: 214
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

January 1, 2014
Medical devices – Application of usability engineering to medical devices
A description is not available for this item.
January 1, 2014
AMENDMENT 1 Medical devices – Application of usability engineering to medical devices
A description is not available for this item.
IEC 62366
October 1, 2007
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

Advertisement