Gaining Competitive Advantage through IEC 62366 ‘Application of usability engineering to medical

IEC 60601-1 3rd Edition requires that manufacturers must address the risks of poor usability, including those associated with identification, marking and documents.
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IEC 62366
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Sept. 12, 2012 - PRLog -- A report in 1999 by the Institute of Medicine titled, ‘To Err is Human: Building A Safer Health System’ stated that at least 44,000 people, and perhaps as many as 98,000 people, die in US hospitals each year as a result of medical errors that could have been prevented. The report warned that errors were due to faulty systems, processes and conditions that lead people to make mistakes or fail to prevent them.

Today, both the EU Medical Device Directive (MDD) and U.S. Food and Drug Administration (FDA) require that human factors and risks of use errors are accounted for in the development of medical devices. International standards, such as IEC 60601-1 3rd Edition and specifically IEC 60601-1-6, address usability engineering and aim to minimize risks caused by poor usability. In any situation where medical devices are used, there is a responsibility to ensure only well-designed, ergonomic products make it to market. The easier a product is for the user, the safer it is for the patient, and consequently the product can increase its competitiveness in the market place.

Usability Engineering as a Process Cycle

IEC 62366 provides extensive guidance on how to implement usability engineering to minimize risks. The standard defines the following steps for the user interface design cycle within the medical context:

1.   Define application and essential performance
2.   Define frequently used functions
3.   Identify hazards related to usability
4.   Define primary operating functions
5.   Create usability specification
6.   Create usability validation plan
7.   Design and implement user interface
8.   Verify usability
9.   Validate usability

How to Design Good Usability for Medical Devices?

It is not possible to add good usability into a product as an afterthought. In order to meet the requirements of IEC 62366 (, usability engineering has to be incorporated into planning from day zero and the process needs to be recorded all the time. Regulations have made usability engineering a must, but at the same time good usability is a great distinguisher and part of a competitive advantage.

If a user doesn’t need to ask instructions, or develop workarounds to accomplish what he/she intends to do, you are on the right track with your product. If you have, at the same time, crafted an aesthetically pleasant piece of equipment or software, you are about to create a winner.

About SGS Medical Devices Services
SGS is one of the premiere organizations accredited for the certification of electro-medical equipment. SGS experts can help executive level management, engineering professionals, compliance executives, legal departments, and medical professionals to better understand and comply with recent changes to standards and directives on medical device safety. SGS’ Medical Services ( cover the IEC 60601-1 3rd Edition standard governing medical device safety as well as risk management under ISO 14971.

For more information about IEC 62366, please contact the SGS experts.

Contact details:

SGS Consumer Testing Services

Seppo Vahasalo
Product Line Manager - Medical Devices
SGS Fimko Ltd
Särkiniementie 3
P.O.Box 30
FI-00211 Helsinki, Finland

t : 358 40 560 9500

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.
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