Join us on Wednesday, July 29, 9 AM Pacific (Noon Eastern), for a live Zoom conversation with Leo Eisner the “IEC 60601 Guy” of Eisner Safety Consultants and Rob Packard of Medical Device Academy. Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation. See the infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.
What is the Scope of IEC 60601-1:2005 (3rd edition)?
This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product. Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is, “Does this medical electrical product fall
IEC 60601-1, 3rd ed. related standards changes & new Interpretation Sheet 3
IEC 60601-1, 3rd ed. has been out for about 7 years now and there have been lots of changes within the IEC 60601 series of standards to align with 3rd edition.
DRAFT results implementation of 3Ed (EN60601 series) for CE marking
This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity” On October 1, 2011 the DRAFT “FAQ related to Implementation of EN