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Japan Announces updates to IEC 60601 3rd edition transition

January 13, 2016

In Bulletin No. 201 505 issued October 13, 2015, JFMDA announced a 5-year transition between JIS T0601-1, the equivalent of IEC 60601-1:2005 (3nd edition) to IEC 60601-1:2005 with Amendment 1 (2012).

Since March 1st 2014, Japan’s MHLW and PMDA recognizes the national equivalent of IEC 60601-1 – 2nd edition, IEC 60601-1:2005 (3rd edition) and 60601-1:2005 with Amendment 1.  Manufacturers can continue to use 2nd edition through May 31st, 2017, and the 3rd edition through February 28th, 2019.  Starting March 1st 2019, the agency will only recognize test reports to the national equivalent of IEC 60601-1:2005 with Amendment 1.