Medical

Medical

Medical

The everincreasing number of electrical and electronic products used in the medical industry has increased the need for awareness of the correct operation of the product within its intended electromagnetic environment. This is of critical importance in that the potential malfunctioning of a product may create not only an inconvenience, but in some cases could result in life threatening situations.

Within the EU, CE marking for medical products is mandatory and applicable directives for achieving this are:

  • The EMC council directive 89/336/EEC, which mandates emissions and immunity standards for all electrical and electronic products
  • The Medical Device Directive (MDD) 93/42/EEC, which covers all instruments used in the diagnosis and treatment of humans.
  • The Active Implant Medical Device Directive (AIMDD) 90/385/EEC, which covers all medical devices that may be implanted into the human body.
  • In-Vitro Diagnostic Medical Device Directive 98/79/EEC, which covers instruments and equipment used for examining substances taken from the human body for diagnostic purposes.

Collateral standard EN60601-1-2 covers EMC requirements for all equipment and systems covered by the Medical Device Directive. Although test techniques and requirements are derived from the basic standards, such as the EN61000 series, EN60601-1-2 recognises that the varied and specialist nature of medical equipment will require that test levels should be applied with the products end use in mind.