Results 9 found
September 17th, 2015
Health Canada recognizes IEC 60601 3rd edition with Amendment 1

According to the Health Canada website, effective August 31st, 2015, Health Canada now recognizes both IEC 60601 3rd edition (ed.3.0) and 3rd edition with Amendment 1 (ed.3.1). The equivalent Canadian National Standard CAN/CSA-C22.2 NO. 60601-1:14 is also on the recognized standards list under “Electromedical.” This means that medical device manufacturers looking to sell their products… read more

March 12th, 2015
IEC issues 2nd edition of IEC 60601-1-11, Medical Equipment in the Home Healthcare environment

Earlier this year, the IEC finalized and published the latest edition of IEC 60601-1-11:2015, the Collateral standard for medical devices used in the Home Healthcare environments. Manufacturers of applicable devices need to consider the additional risks posed as more devices move to support patients and health outside of the clinical environment, including ease of use,… read more

December 1st, 2013
OSHA ready to recognize 3rd Edition

As of January 1, 2014, the U.S. FDA will require new electromedical device submissions via including 510(k) and PMA to demonstrate conformity to IEC 60601-1:2005 plus Amendment 1.   As of Nov. 25, 2013, OSHA has now indicated through a Federal Register notice that it intends to recognize ANSI AAMI ES 60601-1:2005 (3rd edition) for certified… read more

October 1st, 2013
New Amendment 1 to EN60601:2006 has been published by CELELEC

The new CENELEC Amendment 1 to EN60601:2006 (3rd edition) includes all elements from the IEC Amendment 1 from 2012 and additional extra material located in both Annex ZA and Annex ZZ. Medical Device Manufactures will find increased detail in the new Amendment – Especially the Annex ZZ – The relationship between this European Standard and… read more

June 1st, 2013
Link to US FDA notice on transition dates to 3rd edition

Effective 6/30/2013 the US FDA will no longer accept references to 60601 2nd Edition in any submissions.  Sponsors/manufacturers pursuing FDA for approval of electrical medical devices will need to show compliance to ES60601-1 3rd ed.  This is an across-the-board requirement for all aligned and Recognized Collaterals and Particular standards. This change affects all new submissions… read more

September 1st, 2012
What is going on with 60601 3rd Edition now that June 1st 2012 has passed?

Now that the European Union effective date of June 1, 2012 for the 3rd Edition of IEC 60601-1 has come and gone, many of our customers have asked, “What’s next?”  Here we provide a brief update on some of the developments on both the Regulatory and Standards front. Regulatory European Union Notified Bodies: It must… read more

August 1st, 2012
C-UL Classification of 60601 2nd edition products past July 2014

There is a difference between expectations amongst Regulators, sometimes even within the same country.  For example, in the US, we have the FDA looking for 60601 3rd Edition compliance (new and significant changes to existing devices) in 2013, whereas OSHA, under their NRTL program, has yet to recognize the 3rd Edition.  This means that it… read more

July 1st, 2012
Amendment 1 of IEC 60601 3rd edition Passes Vote

The voting members of the National Committees overwhelmingly voted “Yes” in favor of publishing the IEC 60601 3rd edition Amendment 1 FDIS as an International Standard.  The ballot was circulated in late April 2012, with a closing date of June 29, 2012.  Now that the National Committees have voted, the IEC will need to formally… read more

April 1st, 2012
Software, 60601 and the Essential Requirements of the MDD

The Essential Requirements of the MDD effectively require that any software incorporated into a medical device be subject to a software development lifecycle process.   Traditionally, manufacturers relied upon the harmonized standard EN 60601-1-4 to meet these requirements. However with the DOCOPOCOSS of the 2nd edition of EN 60601-1, and with it the collateral standards including… read more