Medical devices - Application of usability engineering to medical devices
Also Known As:
SKU916214729
Published by
International Electrotechnical Commission
IEC
Publication Date2014-01-28
Pages CountPages442
IEC 62366:2007+A1:2014 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.
This consolidated version consists of the first edition (2007)
and its amendment 1 (2014). Therefore, no need to order amendment in addition to this publication.
Details
History and complementary documents
History
| Edition | 1.1 |
| ICS Codes | 11.040.01 - Medical equipment in general |
| Language(s) | English + French |
| File Size | 4.1 MB |
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