International Electrotechnical Commission

Medical devices – Part 2: Guidance on the application of usability engineering to medical devices - Edition 1.0
 N TR 62366-2

Annotation

This Part of IEC 62366, which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.

NOTE 1 SAFETY is freedom from unacceptable RISK, which is described in ISO 14971. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to direct physical HAZARDS or to loss or degradation of clinical performance.

NOTE 2 The PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE, as it relates to SAFETY is found in IEC 62366-1:2015.

This technical report has two main themes:

• information about efficient ways to implement elements required by IEC 62366-1:2015; and

• additional information, in particular how USABILITY relates to attributes such as TASK EFFICIENCY and USER satisfaction, which can enhance a MEDICAL DEVICE’S commercial success.

This technical report discusses the business benefits of USABILITY ENGINEERING, the basics of applicable analysis and design techniques, MEDICAL DEVICE USABILITY EVALUATION approaches, efficient ways to address USABILITY ENGINEERING project implementation issues (e.g. integration into a quality management system) and provides a list of useful USABILITY ENGINEERING resources.