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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, as of 2011 it consists of a general standard, about 10 collateral standards, and about 60 particular standards. ==General standard== The general standard ''IEC 60601-1 - 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 requirement for the commercialisation of electrical medical equipment in many countries.〔(The use of IEC 60601-1 in supporting approvals of medical electrical devices )〕 Many companies view compliance with IEC 60601-1 as a requirement for most markets. National deviations of this series of standards exist which include country specific requirements;〔(National Deviations to IEC 60601-1 by MDDI )〕〔(National Deviations to IEC60601-1 by Eisner Safety Consultants )〕 see e.g. UL or AAMI for US specifics.〔http://ulstandardsinfonet.ul.com/harm/drafts/medical/s60601-1_1.pdf〕〔http://www.aami.org/news/2010/081010.press.606011.html〕 The European EN and Canadian CSA versions of the standard are identical to the IEC standard. However, according to the recent publication of the US national version of the standard, ANSI/AAMI HA60601-1-11, the application of the standard does not apply to the nursing home environment. In the United States, nursing facilities are considered to be environments providing professional healthcare. The American version of the new standard also places greater emphasis on a requirement which states that “inspection of the usability engineering file reinforce that the usability engineering process is necessary for validation of the instructions for use.” Devices typically mandated to use the new standard include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors, and associated battery chargers prescribed for use at home. Although In Vitro Diagnostic devices such as blood glucose meters are being used by patients at home, the standard does not apply, as these devices remain under the jurisdiction of the more lenient IEC 61010 series. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「IEC 60601」の詳細全文を読む スポンサード リンク
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