EN 60601 Medical Electrical Equipment and Systems

Gain market access in Europe with EN 60601 and CE marking

EN 60601 Medical Electrical Equipment medical devices BSIManufacturers who wish to place Medical Electrical Equipment on the European market must apply CE marking to their device to indicate compliance with applicable European Medical Device Directives.

The Medical Device Directives contain Essential Requirements that must be in compliance with harmonized standards as this is the preferred way of demonstrating this since they offer a 'Presumption of Conformity'. This makes understanding and meeting the requirements of EN 60601 fundamental for all manufacturers of Medical Electrical Equipment.

What is EN 60601 Standard?

EN 60601 is a family of standards whose scope covers the safety, essential performance and electromagnetic compatibility of Medical Electrical Equipment and Systems. It is technically equivalent to the international standard IEC 60601 and the family comprises over 70 separate Standards.

The “Part 1” standard, EN 60601-1 covers basic safety and essential performance for all Medical Electrical Equipment and the “Part 2” or “Particular” standards cover requirements for specific product groups (e.g. EN 60601-2-22 for Medical Lasers).

Complying with EN 60601-1 Standard

EN 60601-1 applies to all Medical Electrical Equipment and Medical Electrical Systems. Medical Electrical Equipment is defined in the standard as electrical equipment having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is:

  • Provided with not more than one connection to a particular supply mains; and
  • Intended by its manufacturer to be used: in the diagnosis, treatment, or monitoring of a patient; or for compensation or alleviation of disease, injury or disability.

This includes a wide range of medical devices, for example:

  • High Frequency Surgical Equipment
  • Cardiac Defibrillators
  • Patient Monitors
  • Therapeutic and Diagnostic Ultrasound Equipment
  • Medical Lasers
  • Patient Ventilators
  • Infant Incubators and Warmers

Testing to show compliance with EN 60601-1 requires a detailed understanding of the requirements together with dedicated test equipment. For the latest changes to the standard see EN 60601-1 3rd Edition Position Paper. These include the introduction of extensive Risk Management requirements that need to be addressed.

Why choose BSI for medical device compliance to EN 60601?

  • We have been testing to the requirements of EN 60601-1 for over 30 years
  • Our laboratories are members of the CB Scheme which provides global recognition of test reports and certificates
  • We can offer a pre-test inspection and help develop test plans including risk management expectations
  • Our regulatory experts are product specialists for a wide range of devices with many years experience in design and testing