IEC 62366:2007 Withdrawn
Medical devices - Application of usability engineering to medical devices
Note: this publication has been replaced by IEC 62366-1:2015
Abstract
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.
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, 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.
This International Standard does not apply to clinical decision-making relating to the use of a medical device.
Additional information
Publication type | International Standard |
---|---|
Publication date | 2007-10-18 |
Withdrawal date | 2015-02-24 |
Edition | 1.0 |
Available language(s) | English/French, Spanish |
TC/SC | TC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss |
ICS | 11.040.01 - Medical equipment in general |
Stability date | 2015 |
Pages | 209 |
File size | 2481 KB |
The following test report forms are related:
More information
Share this page
Share your publications
Learn how to share your publications with your colleagues, using networking options.
Payment information
Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa, JCB and CUP), PayPal and bank transfers as form of payment.
Keep in touch
Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.
Contact customer services
Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 16:00 CET Monday to Friday.