IEC-60601-1-6 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability

IEC-60601-1-6 - EDITION 3.1 - CURRENT -- See the following: IEC-60601-1-6-AM1
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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 b 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 b



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Document Number

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

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Publication Date

Oct. 28, 2013

Committee Number