BS EN 60601-1-6:2010 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
BS EN 60601-1-6 is the British standard that 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, hereafter referred to as me 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 part of BS EN 60601 has been complied with and the acceptance criteria documented in the usability validation plan have been met (IEC 62366), 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.
Contents of BS EN 60601-1-6 contain:
- Introduction
- Scope, object and related standards
- IEC 60601-1
- Particular standards
- Normative references
- Terms and definitions
- General requirements
- Conditions for application to me equipment
- Usability engineering process for me equipment
- Replacement of requirements given in IEC 62366
- General guidance and rationale
- Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007
- References to items of USABILITY provided in IEC 62366:2007 and their use in other standards
- Bibliography
- Index of defined terms used with this collateral standard
- Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007
- References to items of USABILITY in IEC 62366 and their use in other standards
This part of BS EN 60601 has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC as well as Annex I of the EC Directive 90/385/EEC.
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 me 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 endeavour.
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 minimise use errors and to minimise 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.
The first and second editions of this collateral standard 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.
This collateral standard 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.
Also available for medical electrical equipment:
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects. General requirements
BS EN ISO 14971:2009 Medical devices. Application of risk management to medical devices
