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IEC 60601-1-6 medical electrical device
DEKRA Product Testing

DEKRA has all the knowledge and expertise for certification of IEC 60601-1-6

IEC 60601-1-6

Testing medical devices according IEC 60601-1-6 standard

IEC 60601-1-6 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.

What is the purpose of 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. The full name of IEC 60601-1-6 is: ‘General requirements for basic safety and essential performance – Collateral standard: Usability’. The purpose of the IEC 60601-1-6is 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.
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What are the IEC 60601-1-6 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 IEC 60601-1-6 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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What is the impact of the recent changes to the IEC 60601 standard? Request the free whitepaper via the button below.
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Certifying your equipment against IEC 60601-1-6?

Interested in certifying your equipment against the IEC 60601-1-6 standard? Then request a quote using the button below. Would you simply like to learn more about our IEC 60601-1-6 certification or do you have any questions? Then get in touch with our expert using the contact block below. Our experts would like to help you.
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