With medical devices, user-friendliness and ergonomics are essential, but sometimes a designer's intention does not match up with the user's experience. IEC 62366, however, offers a comprehensive and proven process for ensuring device usability, as Richard Poate, medical health services manager at TUV SUD Product Service, explains IEC 62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices, is applicable to both manufacturers of complete medical devices, and manufacturers of accessories intended for medical devices. It is a state-of-the-art standard and is therefore required for certification under the Medical Device Directive (MDD), and is also mandatory for the CB (global market access) and NRTL (North America market access) schemes.
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