Results 5 found
October 24th, 2016
UL Northbrook expands CBTL scope with 3 additional IEC 60601 Medical Particular Standards for use with IEC 60601

UL has expanded its scope at its Northbrook, IL laboratory and can now offer IECEE CB Scheme testing, reports and certificates to three ISO 80601 Particular standards. ISO 80601-2-35:2009 Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for… read more

January 13th, 2016
Japan Announces updates to IEC 60601 3rd edition transition

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… read more

November 30th, 2015
New FDA EMC Guidance reinforces importance of complete test reports

UL staff member, Bob DeLisi recently attended the ASC C63® standards meeting responsible for voluntary standards relating to EMC in the United States.  FDA was present at this meeting and presented information about the recent EMC guidance document “Information to Support a Claim of EMC of Electrically-Powered Medical Devices.”  The new Guidance was issued because the… read more

November 12th, 2015
ANVISA new rule requires IEC 60601 with Amendment 1

On September 25, 2015, the Brazil National Health Surveillance Agency (ANVISA) issued a new rule IN 4, 2015-09-24, (that supersedes the IN 11, 2014-12-16) and which require the IEC 60601-1 Ed. 3.1 (3rd edition with Amendment 1) mandatory for any new products seeking ANVISA approval.  For all projects started and quotes accepted after September 25,… read more

August 7th, 2014
IEC 60601-1 for Medical Electrical Equipment Safety

IEC 60601 testing and certification services for global markets IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries. In addition to basic safety requirements, the third edition with amendment 1 includes requirements for essential performance, software, usability, lasers and EMC that can be delivered locally via… read more