IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, it is made up, as of 2011, of a general standard, about 10 collateral standards, and about 60 particular standards.
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The general standard IEC 60601-1 - Medical equipment|medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a de-facto requirement for the commercialization of an electrical medical equipment in many countries.[1] Many companies view compliance with IEC 60601-1 as a de facto requirement for most markets.
National deviations of this series of standards exist which include country specific requirements;[2][3] see e.g. UL or AAMI for US specifics.[4][5]
In 2005, the third edition of IEC 60601-1 was published. It was the result of a comprehensive review of the second edition (dating from 1988). Some key changes are: the outline and the numbering scheme of the clauses and subclauses were changed, risk management was made much more relevant and the concept of essential performance was added. Currently (2011), the applicability of the second and third edition is somehow overlapping[6][7] depending on the products under consideration and the country/area of application.
Requirements of 60601-1 may be overridden or bypassed by specific language in the standards for a particular product. Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, e.g. Electromagnetic Compatibility (IEC 60601-1-2) or Protection for diagnostic use of X-rays (IEC 60601-1-3). Particular standards (numbered 60601-2-X) define the requirements for specific products, e.g. MR scanners (IEC 60601-2-33) or Electroencephalograms (IEC 60601-2-26). [8][9]. Collaterals and Particulars may have their own revisions which are different from the General Standard.
IEC 60601-1-9 for Environmentally Conscious Design of Medical Electrical Equipment published July 2007 is a collateral standard to IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Medical Solutions. The Part 9 standard asks manufacturers of medical devices to consider the environmental impacts of their devices throughout the product's entire life cycle and to minimize these where possible. The standard also requires that the manufacturer provide information to the user on how to use the product in the most environmentally sensitive way. The USA, Canada, Japan, Australia and New Zealand have not yet set transition dates for their national versions of this latest edition 60601-1, but the national versions published to date do contain the requirement to also conform with IEC 60601-1-9. However, the European version (EN 60601-1:2006) requires compliance with the new IEC 60601-1-9 collateral standard by September 2009.