(Originally posted March 5, 2014 & updated March 6, 2014) The changes made to these 16 Delegated Directives to the RoHS 2 Directive (2011/65/EU) add more exemptions to Annex IV of the Directive. Annex IV is for the “Applications exempted
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This post discusses NBRG’s call to participate in an Industry Survey on Industry’s Practice of Risk Management Process per EN ISO 14971:2012. On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a letter
TÜV SÜD & Global EMC IEC 60601-1, 3rd ed Seminar
TÜV SÜD Canada & Global EMC will be giving an all day seminar on IEC 60601-1, 3rd ed. on Feb 21, 2014 in the Montreal, Canada area for a very reasonable cost of $100. This will be on the test
Leo Eisner Track Chair at MD&M West Conf 11-Feb Discuss EN ISO 14971:2012
UBM Canon Communications has graciously asked me to join this year’s MD&M West Conference with the honor of being the track chair for the Risk, Quality & Validation track on Tues 11 Feb 2014. We have a great line up that day
IEC 60601-1 PATIENT APPLIED PARTS of MEE – Notes 1, 2, & 3 – Part 2 of 2
In this blog, we continue our discussion on Patient Applied Parts, in Part 2, by explaining the 3 notes associated with the definition of Applied Parts, 3.8 of IEC 60601-1, 3rd ed & ed. 3.1. We use several figures to