Before placing medical electrical devices on the global markets, the manufacturer must ensure that those products are electrically safe. This mandatory process comprises, among other characteristics, demonstrating that the device poses no fire, shock, or overall safety hazards to the patient or end user that comes in contact with it.

The most widely accepted standard for Electrical Safety tests is the IEC 60601 series. These series consist of a General Standard (Part 1 standard, IEC 60601-1), Collateral standards (IEC 60601-1-XX) that shall be used together with the general one, and Particular (product-specific) standards (Part 2 standards, IEC 60601-2-XX) for some products.

The latest revision of IEC 60601-1 brought about a profound change in that the standard is now intended to serve as a tool in the risk management process. Therefore, certification under 60601-1 is not possible without compliance with ISO 14971 “Medical devices - Application of risk management to medical devices”.

Contact us for any assistance you may need in preparation or implementation of any Electric Safety validation tests for your products. Training, step by step guidance, onsite or online consulting is also available along with our full lab testing services.

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