On 30 Aug 2012 the EU Commission released updated lists of Harmonized Standards for the Medical Device Directive, the Active Implantable Directive, and the In-Vitro Diagnostic Directive.
Leo Eisner Speaking on “IEC60601-1, 3rd ed. – Where Do We Stand on Nat’l Implementation” 27 SEPT ’12
Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition – Where Do We Stand on National Implementation?” at an FX Conferences on Sept 27, 2012 at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to leave
Dangerous Voltages out in the Open (Contact Voltage)
There is a danger that is out in the open (on our sidewalks, at playgrounds, the little league baseball park, etc.) and most people don’t even know what it is.
Medical Devices Utilizing Tissues of Animal Origin New EU Commission Regulation
This post is on the newly published Commission Regulation (EU) No 722/2012 of 8 August 2012 “concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
IEC 60601-1:2012 Consolidated 3.1 Edition Just Published
On August 20, 2012 IEC released the consolidated edition 3.1 of IEC 60601-1:2012 which is a combination of IEC 60601-1:2005 (also known as 3rd ed. of IEC 60601-1) combined with Amendment 1:2012 (A1).