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IEC 62366 standard at DEKRA.
DEKRA Product Testing

Are your medical devices safe to use?

IEC 62366

Usability engineering for medical devices

Medical devices must be safe to use without causing harm to users or patients. This applies to medical devices with and without an electrical component. To ensure this safety, IEC 62366 applies to medical devices. This international standard focuses on the user-friendliness of the equipment, also known as usability engineering. It requires that everyone, including doctors, nurses, and individuals without medical experience, can safely use medical devices.

IEC 60601-1-6 applies to electrical medical devices. This standard is used for analyzing, specifying, designing, verifying and validating usability. IEC 60601-1-6 references to IEC 62366 because it describes exactly how a manufacturer should carry out the usability engineering process. DEKRA uses the documentation provided to check whether you as a manufacturer comply with the standard and can provide guidance on how the process should be followed.
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What is IEC 62366?

IEC 62366 is an international standard that assists manufacturers of medical devices by providing a process for analyzing, specifying, developing, and evaluating the usability of a medical device. This enables you as a manufacturer to assess and mitigate risks associated with correct usage. The standard consists of two parts:
  • IEC 62366-1: Specifies the usability engineering process for medical devices.
  • IEC 62366-2: Guidance in the form of a technical report for the application of usability engineering to medical devices. IEC 62366-2 contains only guidelines and background information that may be useful for a usability engineering process and therefore are not requirements.

The usability engineering process

To ensure that the medical device meets user and patient safety requirements, several steps must be followed. Some components of the usability engineering process include:
  • Define the users, environment, and user interface;
  • Identify risks related to the use of the medical device;
  • Develop and implement risk mitigation measures to ensure safety;
  • Confirm the usability and effectiveness of the medical device.
If validating usability reveals new risks or additional measures are needed, the previous steps must be repeated.

DEKRA & IEC 62366

DEKRA verifies, based on the provided documentation, whether you as a manufacturer have followed the IEC 62366 standard correctly. Since IEC 60601 references IEC 62366, IEC 62366 certificates are not issued. Only an IEC 60601-1 + IEC 60601-1-6 certificate is issued.
In addition to verifying compliance with the standard, DEKRA's experts have all the knowledge and expertise regarding usability and IEC 62366. If you have any questions about this standard or certifying your medical devices, feel free to contact one of our experts.