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).
Two Conf’s on 60601 Series of Stds Mar 3 & 4th
Come join Eisner Safety Consultants at one or both conferences March 3 & 4th. Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and
Leo Eisner Presenting at RAPS/ASQ on IEC60601-1 3rd ed.
Biomedical Division Northern California Discussion Group andSan Francisco Bay Area Chapter Topic: “Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas: IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration,
Eisner Safety Consultants Newsletter #5 Now Online
Eisner Safety Consultants Newsletter #5 Now Online This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon. Also, we would be
FDA Formally Recognize IEC 60601-1, 3rd ed.
The FDA is to Formally Recognize the Medical Electrical Safety Standard IEC 60601-1:2005, 3rd ed From AAMI March 12, 2010 press release The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.