On May 16, 2014 the EU updated the Official Journal for the Medical Device Directive. One of the updates was to include the EN versions of 60601-1 with Amendment 1. After 12/31/2017, customers using the 60601-1 standard as a presumption of conformity will need to use the EN 60601-1:2006/A1:2013. For more information on the EU… read more
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