IECEE ensures that all medical electrical and electronic devices and equipment are reliable and meet expectations in terms of performance, safety, reliability and other criteria. This applies not only to the medical electrical equipment itself but also covers risks to patients, those who operate the equipment – doctors, nurses and technicians, for instance – and maintenance personnel.
IECEE manages the risks surrounding medical electrical equipment. Its task has become more important as technological changes and enhancements have radically increased the complexity of the sector.
In 2007 it set up the IECEE Medical Electrical Equipment (MEE) Task Force whose responsibility is to deal with the implementation of risk management requirements as set out in the third edition of IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, published in 2005 (Consolidated edition 3.1 of IEC 60601-1 published in 2012).
Healthcare services and the application of medical electrical equipment, healthcare software and IT networks are growing rapidly driven by the facts that:
- the life-expectancy of the population is increasing;
- the population is significantly growing;
- there is an increasing impact of information technology;
- new technologies such as bioengineering are contributing;
- cost saving goals are gaining importance in medical practice; and
- developing countries are generating new equipment markets.
Regulation affecting medical devices is increasing with a growing emphasis on quality systems and standards. Examples are within the European Community where certification to standards plays a key role in demonstrating compliance with medical device regulations and within the US Food and Drug Administration (FDA), which is enlarging its use of international standards in the device approval process. In China there is an increasing importance of international standards for the approval of products.
IEC Technical Committee (TC) 62: Electrical equipment in medical practice was established in 1986 to prepare International Standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons and the environment.
In recent years, IEC TC 62 has increasingly worked in the field of software, IT and networks and developed new International Standards and other publications in that area.
IEC International Standards published by TC 62 Subcommittees cover safety and performance for specific products, such as diagnostic imaging, radiotherapy, nuclear medicine, radiation dosimetry, electromedicine, anaesthesia, critical care, surgery, artificial respiration and paediatrics.
More information on TC 62, its liaisons with other IEC TCs as well as with International Organization for Standardization (ISO) TCs and other organizations active in the medical field, can be found on the TC dashboard and in its Strategic Business Plan.