DEKRA Product Testing
DEKRA has all the knowledge and expertise for certification of IEC-60601-1-6
IEC 60601-1-6
Medical electric devices must be safe and effective in their use. IEC 60601-1-6 is a standard which forms part of
IEC 60601,
a series of standards for medical electrical devices. This particular standard describes the process for a manufacturer to analyse, specify, design, verify and validate usability. This enables the usability risks to be identified, assessed and mitigated and so raise the safety of your medical devices to a higher level. DEKRA has the experts in-house who can test and certify your equipment for IEC 60601-1-6 and who will be happy to act on your behalf.
The purpose of IEC 60601-1-6
The full name of IEC 60601-1-6 is: ‘General requirements for basic safety and essential performance – Collateral standard: Usability’. The purpose of the standard is to enable those who use the equipment to do so without harming themselves or the patient. The term usability applies to anyone using the equipment: doctors, nurses and patients, but also those without any medical experience.
The requirements
IEC 60601-1-6 stipulates that the documents which describe the usability process and the reports of any usability tests must be recorded on file. The standard does not include any specifically described steps. This gives you some degree of freedom to choose usability techniques which best match the complexity of your product. Nevertheless, you need to have usability specifications and a validation plan.
The usability specifications contain details about intended users and patients, plus a task analysis. This includes a list of user risks associated with the device. Sometimes the specifications also include a style guide so that consistency in the interface is guaranteed.
The validation plan describes the tests which must determine whether the device satisfies the usability specifications. The validation tests must be based on how the devices actually works in practice. This can also be simulated. Practical use of the device will bring issues to light which would otherwise not show up, since simulations cannot replicate all the details. On the other hand, prototypes can be tested at a much earlier stage in a simulated environment, which means that any problems can be addressed much sooner.
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