Electromagnetic interference resistance

EN-60601-1-2 Ed. 4 - electromagnetic immunity of medical devices

It is particularly important in medical areas, such as doctors’ practices and clinics, that medical technology products are protected against malfunctions and failures caused by electrical emissions.

Conversely, electrical devices must not be allowed to negatively influence their environment by emitting electromagnetic vibrations. The European product standard EN 60601–1‑2, which is equally valid in the US, therefore requires the “electromagnetic immunity” of medical devices. This not only protects the devices but can also save lives in an emergency.

Which products need to be certified according to this standard?

Any products, which are defined as a “medical product” or “medical system”, need to be tested and certified according to EN 60601 or one of its partial standards. Manufacturers can also certify their products according to this standard or one of its partial standards on a voluntary basis, even if their items are not defined as a medical product.

What requirements does the standard place on medical products?

The types of electromagnetic interference that medical products have to cope with without any problems;

• How much electromagnetic radiation medical products may emit;
• How the requirements in this respect may depend on the specific environment where the unit is used and the risk emanating from the product;
• How it is necessary to measure, test and document these measurements; and
• How the manufacturer must mark the product and which information must be found in the operating instructions.

The following products comply with these regulations:

CleanType Prime Pro+ - backlit, with magnets - KSI-U10200 / KSI-U20200
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InduMouse™ Pro - KH25201
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InduProof™ Smart Classic - KG19269
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The EMV standard does not yet come into force for keyboards and computer mice. However, these electrical devices have become an indispensable part of everyday medical life. We have therefore decided to test our input devices for the medical sector according to EMC criteria.