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SR EN 60601-1-6:2010
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, 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
Status :
Valid
Approval date : 11/30/2010
Number of pages : 28
ICS : 11.040 Medical equipment
Technical Committee : 22 - Electrical equipment in medical practice
- Replaces SR EN 60601-1-6:2007
- Normative reference SR EN 60601-1:2007
- Normative reference SR EN 60601-1:2007/AC:2015
- Normative reference SR EN 60601-1-8:2007
- Normative reference SR EN 62366:2008
- Normative reference SR EN ISO 14971:2009
- Amended by SR EN 60601-1-6:2010/A1:2015
- Amended by SR EN 60601-1-6:2010/A2:2021