Results 5 found
August 28th, 2017
RECORDED WEBINAR: IEC 60601-1-2 EMC

About this webinar: In 2015 the International Electrotechnical Commission (IEC) published the fourth edition of IEC 60601-1-2, a collateral standard that provides the requirements for essential performance and basic safety in the presence of electromagnetic disturbances. The standard introduces electromagnetic (EM) environments of “intended use”, including professional healthcare facilities and home healthcare. UL’s EMC experts… read more

August 3rd, 2017
RECORDED WEBINAR: IEC 60601-1 Amendment 1 and Risk Management

About this webinar: The  IEC 60601-1-2, a collateral standard that provides the requirements for essential performance and basic safety in the presence of electromagnetic disturbances was published in early 2015. In this recorded webinar from June 11th, 2015, UL 60601 expert, Mark Leimbeck discusses the major changes introduced by the IEC in the amendment 1 of IEC 60601, including the… read more

March 21st, 2016
UL’s Mark Leimbeck speaks about risk management at recent MedTech Intelligence conference

During MedTech Intelligence’s recent conference on risk management, experts discussed a range of issues, from patient, clinical and engineering perspectives to evaluating and integrating risk management into various functions within a company. During an interactive panel, Jon Speer, founder & VP QA/RA at greenlight.guru, asks Mark Leimbeck, program manager at UL EduNeering to touch on… read more

February 1st, 2016
China Food & Drug Administration – Local Testing at UL

Relationship with authorized CFDA laboratories allows UL to conduct required safety and EMC testing for medical and lab equipment outside of China With the world’s largest population, and one of the largest and fast growing medical device markets in the world, the prospects for medical device spending in China are huge. The Chinese government has… read more

April 13th, 2015
Clearing up the confusion around 60601-1 Amendment 1 and Risk Management

There continues to be confusion over expectations for manufacturers implementing a risk management process to satisfy IEC 60601-1 and Amendment 1.  Unfortunately, because the 60601 Standard is a type test standard, and necessarily eliminated reference to Clause 9 in ISO 14971 on Post-Production Information, some manufacturers have interpreted this to mean that they need not… read more