IEC 60601-1-6 Usability Testing
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC 60601-1-6 Introduction:
Medical practice is increasingly using medical electrical equipment for observation and treatment of patients. Use errors caused by inadequate medical electrical equipment usability have become an increasing cause for concern. Much of medical electronic equipment developed without applying a usability engineering process are non-intuitive, difficult to learn and to use. As healthcare evolves, less skilled operators including patients themselves are now using medical electrical equipment while the medical electrical equipment itself is becoming more complicated. In simpler times, the operator of the medical electrical equipment might be able to cope with an ambiguous, difficult-to-use operator-equipment interface. The design of usable medical electrical equipment is a challenging endeavor. The design of the operator-equipment interface to achieve adequate (safe) usability requires a very different skill set than that of the technical implementation of that interface.
The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimize use errors and to minimize use-associated risks. Some, but not all, forms of incorrect use are amenable to be controlled by the manufacturer. The relationship of the usability engineering process to the risk management process is described in Figure A.1 of IEC 62366:2007.
The first and second editions of IEC 60601 1 6 and EN 60601 1 6 described a usability engineering process that was tailored to the needs of manufacturers of medical electrical equipment. They provided guidance on how to implement and execute the process to improve the safety of medical electrical equipment. Sub-clause 1.3 of IEC 60601-1:2005+A1:2012 states that, “Applicable collateral standards become normative at the date of their publication and shall apply together with this standard.”
Consequently, the second edition of IEC 60601-1-6 was developed specifically to align with IEC 60601-1:2005 and published in 2006. All other relevant collateral standards within the jurisdiction of IEC Subcommittee 62A also were updated and republished between 2006 and 2007 except for IEC 60601-1-1 and IEC 60601-1-4. These collateral standards were not revised because their requirements were integrated into IEC 60601-1:2005. After the second edition of this collateral standard was published, IEC Subcommittee 62A, in partnership with ISO Technical Committee 210, developed and published a general usability engineering standard applicable to all medical devices—IEC 62366:2007. IEC 62366 is based on IEC 60601-1-6, but was refined using the experience gained with applying the first edition of IEC 60601-1-6. Although the processes described in IEC 60601-1-6:2006 and IEC 62366:2007 are very similar, they are not identical.
At its Auckland meeting in 2008, IEC Technical Committee 62 approved a project to revise IEC 60601-1-6 so that it would reduce or eliminate duplication with IEC 62366 and also create a bridge between IEC 60601-1 and IEC 62366. This third edition of IEC 60601-1-6 creates that bridge and will enable a manufacturer to conform to the requirements in IEC 60601-1:2005 that make normative reference to IEC 60601-1-6 by employing a usability engineering process complying with IEC 62366:2007. At a point in the future, that bridge can be eliminated by revising or amending IEC 60601-1 to include a direct reference to IEC 62366 and, as necessary, adding any additional requirements that are specific to medical electrical equipment, such as those contained in Clauses 4 and 5 of this collateral standard, to IEC 60601-1 or as a normative annex to IEC 62366.
IEC 60601-1-6 testing is intended to be useful not only for manufacturer(s) of medical electrical equipment, but also for technical committees responsible for the preparation of particular medical electrical equipment standards. It should be noted that clinical investigations conducted according to ISO 14155-1 and usability testing for verification or validation according to this standard are two fundamentally different activities and should not be confused.
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