PD IEC/TR 62366-2:2016

What is PD IEC/TR 62366-2 – Guidance on usability engineering to medical devices about ?

PD IEC/TR 62366-2 is an international standard that focuses guidance on the application of usability engineering to medical devices, ensuring the operability, productivity and efficient workflow in medical applications. 

PD IEC/TR 62366-2 is a technical report, that 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. 

PD IEC/TR 62366-2 has two main themes: 

• Information about efficient ways to implement elements required by IEC 62366-1:2015 
• 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 

Note 1: Safety is freedom from unacceptable risk, which is described in ISO 14971. unacceptable risk can arise from user error, which can lead to exposure to direct physical hazards or 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. 

Who is PD IEC/TR 62366-2 - Guidance on usability engineering to medical devices for ?

PD IEC/TR 62366-2 on the application of usability engineering to medical devices is useful for: 

• Manufacturing company of medical equipment
• Electrical engineers and assembly point 
• Testing houses and labs for medical devices 
• Usability engineers and consultants 

Why should you use PD IEC/TR 62366-2 - Guidance on usability engineering for medical devices ?

As healthcare evolves, less skilled users including patients themselves are now using medical devices and medical devices are becoming more complicated. As medical devices become increasingly sophisticated, they can be more likely to induce use errors. If not properly designed or safeguarded, medical devices can contribute to hazardous situations.  

PD IEC/TR 62366-2 provides users guidance on integrating usability engineering principles and user interface design practices into their overall medical device development processes. 

PD IEC/TR 62366-2 recognizes that all medical devices involving human interaction present opportunities for optimization through the application of usability engineering and seek to guide the medical device manufacturer’s efforts.  

PD IEC/TR 62366-2 provides users guidance on the quality assessment of user interactions with medical devices that are as varied as acquiring information on a display, pressing a physical button or on-screen touch target button, selecting items on a software menu, attaching accessories to a medical device and interpreting warnings. 

With the adoption of PD IEC/TR 62366-2, users can apply usability engineering to medical devices, enabling the reduction of failed products and reduction in development time and costs for improved performance and operability in medical applications. 

What’s changed since the last update ?

PD IEC/TR 62366-2:2016 supersedes BS EN 62366:2008+A1:2015. PD IEC/TR 62366-2:2016 includes some technical changes concerning BS EN 62366:2008+A1:2015. These include: 

• Guidance for the implementation of usability engineering (human factors engineering)
• Additional information about usability engineering best practices: italic type. 
• Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Text of tables is also in a smaller type