Medical Devices for use in the Home Healthcare Environment

03 May 2012

By Todd Konieczny, North American Medical Technical Leader

IEC 60601-1-11 is a Collateral standard that applies to the basic safety and essential performance of medical electrical equipment and systems manufactured for use in the home healthcare environment. It impacts everything from stand alone devices to systems, including plug-in devices and permanently installed applications. Due to the unknown aspect of the home healthcare environment – and the assumption that operators of home healthcare equipment are not medically trained professionals and possess no more than eight years of education – the standard requires that extra safety, communication and operational precautions need to be put in place.

Manufacturers of medical electrical equipment intended for the home environment are urged to consider the implications of this standard as early as possible. IEC 60601-1-11 is a harmonized standard for the U.S., Canada and Europe. Europe’s adoption deadline is firmly set at June 1, 2013, and the same date is anticipated in the U.S., though not yet confirmed. Since these countries are harmonized, it’s most beneficial for U.S. and Canadian companies to consider Europe’s deadline as their own.

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