This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4th ed. & a discussion of timing of requirements in different world regions. Darryl Ray, of Darryl Ray EMC Consulting, provided the technical and regulatory
Pre-release of IEC 60601-2-52 1st ed + Amendment 1 – Medical Beds
This post is the early release of IEC 60601-2-52, 1st ed. + Amendment 1 (A1) before being issued as an International Standard (IS). It is currently available as an FDIS (Final Draft International Standard) for purchase from IEC. IEC website
OSHA NRTL’s approved for AAMI ES 60601-1 3rd edition + Amendment 1 (or edition 3.1)
This post discusses NRTL’s approved for AAMI ES 60601-1 3rd ed. + A1 & can issue NRTL Marks vs which are in process. There has been a lot of activity from OSHA with respect to the NRTL (Nationally Recognized
BSI White Paper on Generating Clinical Evaluation Reports
Blog focus BSI’s 2nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports White Paper on Generating clinical evaluation reports This white paper is on “Generating clinical evaluation reports – A guide
CAN/CSA C22.2 No. 60601 Standard Changes
Reminder post – withdrawal of CAN/CSA C22.2 No. 601.1-M90+A1+A2 is on June 30, 2014 & CAN/CSA-C22.2 No. 60601-1:14 was recently published