The fourth edition of IEC 60601-1-2 was published on 25 February 2014. It constitutes a significant change in the standard from the third edition of the standard which was published back in 2007.
MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”
7 March 2014 – MD&DI article written by Leo Eisner of Eisner Safety Consultants about the confusion of the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard
NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
On Tuesday Feb 11, 2014 at the UBM Canon Communications MD&M West Conference Leo Eisner of Eisner Safety Consultants presented this material as the Track Chair for “Improving Risk Management Strategies And Procedures”. He spoke on the proposed Consensus Guidance
RoHS 2 Directive (2011/65/EU) Changes to Annex IV (Med Dvcs & Control/Monitoring Instruments) Exemptions Listing
(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
NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012
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