AS IEC 60601.1.6:2017 PDF

Adopts IEC 60601-1-6 to specify a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical equipment (ME).

This Standard was prepared by the Standards Australia Committee HE-003, Medical Electrical Equipment. The objective of this Standard is to specify a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical equipment (ME). 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.

This Standard is identical with, and has been reproduced from IEC 60601-1-6:2010+AMD1:2013 CSV (ED. 3.1), Medical electrical equipment, Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability.