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bd40bc7c7a Some key changes are: the outline and the numbering scheme of the clauses and subclauses were changed, risk management was made much more relevant and the concept of essential performance was added. The American version of this collateral standard also places greater emphasis on a requirement that states that inspection of the usability engineering file reinforce that the usability engineering process is necessary for validation of the instructions for use. Currently (2012), the applicability of the second and third edition is somewhat overlapping depending on the products under consideration and the country/area of application. Collateral and particular standards. Revisions. General standard.
UL or AAMI for US specifics.. External links. Electromagnetic Compatibility (IEC 60601-1-2) or Protection for diagnostic use of X-rays (IEC 60601-1-3). Error Summary HTTP Error 405.0 - Method Not Allowed The page you are looking for cannot be displayed because an invalid method (HTTP verb) is being used. IEC 60601 Medical electrical equipment IEC 60601-1:2005+AMD1:2012 Consolidated version General requirements for basic safety and essential performance IEC 60601-1-2:2014 Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60601-1-3:2008+AMD1:2013 Consolidated version Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 60601-1-9:2007+AMD1:2013 Consolidated version Collateral Standard: Requirements for environmentally conscious design IEC 60601-2-33:2010+AMD1:2013 Consolidated version Magnetic resonance equipment for medical diagnosis IEC 60601-2-26:2012 Electroencephalographs Youtube video explaining the implications of IEC 60601 3rd Edition . The standard also requires that the manufacturer provide information to the user on how to use the product in the most environmentally sensitive way. The European EN and Canadian CSA versions of the standard are identical to the IEC standard. References.