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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 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, that are defined as a “medical product” or “medical system” according to Section 3 of the German Medical Products Act, 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 medical products.

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.

Why is there a new Edition (4) of EN 60601–1‑2?

The environments, where medical equipment is being used, are more complex now than ever before. Technologies are continuing to develop at a rapid pace and this makes it necessary to permanently adapt the requirements that are stipulated in standards. One of the most important new features in EN 60601–1‑2 Edition 4 is the stronger focus on “intended usage environments”, for which risk management is necessary in each case, according to EN 4971 3. This describes the increases in requirements for professional health care, for health care at home and for “special” environments. The tougher EMC test specifications in Edition 4 are also designed to ensure resistance to interference in the relevant conditions.


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.