International Standards and Conformity Assessment for all electrical, electronic and related technologies

 

Medical Equipment

Medical Equipment

Medical equipment is a segment of medical devices that in Europe are regulated by one of the medical devices directives. Most medical equipment is supported by external power, mostly electricity. This type of equipment is then called "medical electrical equipment". Increasingly, this sort of equipment has intelligence on board for communication with the outside world and enhanced functionality to support the user.

 

There is a large variation in medical electrical equipment: ranging from linear accelerators used in radiotherapy to ultrasound machines for diagnosis or therapy, and from electric wheelchairs to hand-held battery-operated devices like blood-pressure meters.

 

Practically all European standards for medical equipment are established at international level in IEC, and then adopted as European standards in CENELEC, with almost no Common Modifications (European amendments). This is important because it allows us to benefit from the experience of experts across the world and to facilitate international trade.

 

The division between medical equipment and medical electrical equipment is not always obvious: sometimes, different versions of equipment exist whereby some are electrically powered and others are manually powered. Ventilators for breathing support in intensive care situations are an example.

 

IEC/TC 62 is the international committee where many standards for medical electrical equipment are developed, mostly related to safety and essential performance. This is important since most of the regulatory requirements specifically relate to those aspects. Key standards are those within the IEC 60601-family, consisting of a basic standard (the "safety bible" for medical electrical equipment), several collateral standards related to horizontal topics (for more information on collateral standards, click here), and over 50 particular standards with specific requirements for certain types of medical electrical equipment.

 

CENELEC/TC 62 is essentially a mirror committee to IEC/TC 62 dealing with the adoption of IEC standards as ENs. European experts provide their contributions to standards directly at the international level through the working groups of IEC/TC 62.


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