The third edition of IEC-60601 was announced in December 2005 and is in the process of being adopted by countries and public health organizations globally. Both Europe and Canada have established a mandatory adoption date of June 1, 2012, and the US has designated July 1, 2013. The FDA now officially recognizes IEC 60601-1, 3rd Edition in the Federal Register. For 510(k) and PMA submissions in the United States, they will continue to accept declarations of conformity to IEC 60601, 2nd Edition until June 30, 2013. After this three-year transitional period, declarations of conformity to IEC 60601, Ed. 2 will not be accepted.
To date, no changes have been required to any of our standard products to meet the 60601-1 3rd edition requirements.
The only change that has come to our attention is for those customers who certify at the system level to 60101-1-11 (Home Healthcare Standard) – the requirement is for a class II (two prong AC connector). We are therefore reviewing our standard product offerings, and will be introducing some additional Class II products into our standard portfolio. We will also be transitioning some of our existing customers from class I to class II power supplies.