In Compliance readers are reminded that several medical electrical equipment standards are approaching their effective dates for the U.S. Food and Drug Administration (FDA) and the European Union (EU)’s DOCOPOCOSS (Date of Cessation of Presumption of Conformity of the Superseded Standard).
Both standards for Electromagnetic Disturbance, IEC 60601-1-2:2014 (ed. 4) and Home health care, IEC 60601-1-11:2015 (ed. 2) have FDA effective dates of April 1, 2017, with the EU anticipating 2017-2018 effective dates. Amendment 1:2012 to General Basic Safety and Essential Performance, IEC 60601-1:2005 (ed. 3.1) has an FDA effective date of August 1, 2016, and an EU effective date of December 31, 2017.
More information about these upcoming standards can be found at http://www.obcompman.com/what-s-new/keepingupwiththeeffectivedates.
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