We have written before about IEC 60601 and its importance to medical equipment manufacturers (look here and here).
For the uninitiated, since 2005 IEC 60601 Was the harmonized standard for medical electrical equipment recognized by most public health authorities globally. The recently released 3rd edition represented a significant change from the 2nd edition.
But all good things must come to an end, and this also goes for standards.
Over the next couple of years, ISO 62366 will replace ISO/IEC 60601-1-6. The new standard expands the scope to include all medical devices, not just electrical ones (see the ISO web site for details)
ISO 62366 is an international standard developed to reduce the risk of medical errors due to poor interface design. Process-based, its goal is to help device manufacturers 'design in' usability and 'design out' use errors.
Importantly for medical translation professionals, the standard also applies to documentation that may accompany a device as well as to the training of intended users. In other words: What used to be a nice-to-know will soon become a must-know standard.
Maria Shepard recently discussed the nine stages of ISO 62366:
- Specify the application of the medical device -identify important characteristics relating to use
- Identify the device's frequently used functions
- Identify and list hazards/hazardous situations related to usability that could impact safety
- Identify the device’s primary operating functions - those that relate directly to the safety of the device and also include the frequently used functions in Stage 2
- Develop the usability specification
- Prepare the usability validation plan - create the test plan to show how the product will be tested
- Describe the process of validating the usability of the device primary operating functions; specify success criteria
- Verify the user interface design against its usability specification; redesign as necessary
- Validate the usability of the medical device - test the device to ensure that user goals have been met
And if you still want more, take a look at:
- Conducting Formative and Summative Usability Studies for Medical Devices
- HFE 101: New FDA Draft Guidance on Human Factors Engineering and Usability Testing
- Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12
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