CAN/CSA-IEC 62366-1:15 (R2020) + A1:21 (CONSOLIDATED) PDF

CSA Preface 

This is consolidated edition 1.1 of CSA IEC 62366-1, Medical devices - Part 1: Application of usability engineering to medical devices, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 62366-1 (edition 1:2015 consolidated with Amendment 1:2020). It replaces CAN/CSA-IEC 62366:14 (adopted IEC 62366:2007). For brevity, this Standard will be referred to as "CSA IEC 62366-1" throughout. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety related aspects of medical device user interfaces. Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence. 

This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. 

Scope 

This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with NORMAL USE, i.e., CORRECT USE and USE ERROR. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. 

NOTE 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to HAZARDS including loss or degradation of clinical performance. 

NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-22, which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary. 

NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.