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IEC 60601-1-6 Ed. 3.1 b:2013

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-6:2010+A1:2013 specifies a process for a manufacturer toanalyse, specify, design, verify and validate usability, as it  relates to basic safety and essential performance of medical  electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with  correct use and use errors, i.e., normal use. It can be used to  identify but does not assess or mitigate risks associated with  abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance  criteria documented in the usability validation plan have been met  (see 5.9 of IEC 62366:2007), then the residual risks, as defined in  ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary  (see 4.1.2 of IEC 62366:2007). The object of this collateral  standard is to specify general requirements that are in addition to  those of the general standard and to serve as the basis for  particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC  62366. To allow for equipment manufacturers and testing  organizations to make products and to equip themselves for  conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be  adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier  than 5 years from the date of publication for equipment already in production.   This consolidated version consists of the third edition (2010)  and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.

International Electrotechnical Commission [iec]

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