Ergonomics & Usability as part of the medical product approval systems in USA and Europe

Conference: MEK 2005 - 4. Medizintechnik- und Ergonometriekongress - Vorträge des DGBMT-Kongresses: Medical Devices: Human Factors and Patient Safety
03/17/2005 - 03/18/2005 at Münster, Deutschland

Proceedings: MEK 2005

Pages: 2Language: englishTyp: PDF

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Scheuer, Stephan (TÜV Rheinland Group, Germany)

Usability standardization for medial devices made progress the last years. In the legislation of the European and US American approval systems it is on the way to get more significance. In USA ANSI/AAMI HE 74 was published and requires the integration of a usability engineering process into the design control of the quality management system for medical device developments. On international standardization level IEC focus to achieve a world-wide harmonized outset with the IEC 60601-1-6. Manufacturer of medical devices designed for the global markets have to consider both standards in the future. Hereby developers can save time and effort with the knowledge of the common requirements.