Results 27 found
August 28th, 2017

PRE-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

PRE-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

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

December 2nd, 2015

Brazil set to require IEC 60601-1-9 by 2016

UL Principal Engineer Pamela Gwynn, recently attended an IEC Technical Committee (TC) 62* meeting in Kobe, Japan where she learned that Brazil’s ANVISA will be starting  to mandate compliance with 60601-1-9** for all medical electrical devices. This intention was confirmed by UL’s Brazil team who explained, the ABNT NBR IEC 60601-1-9:2014 (Portuguese translation of IEC… 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

October 31st, 2014

OSHA expand the scope of recognition for UL as a Nationally Recognized Testing Laboratory (NRTL) under AAMI ES60601-1 with Amendment 1

OSHA recently updated UL’s NRTL scope to include the standard AAMI ES60601-1 with Amendment 1, the safety standard for Medical Electrical Equipment.  This standard with amendment 1 references the ISO 14971:2007 standard for risk management of medical devices. You can read the full scope of UL’s NRTL at: https://www.osha.gov/dts/otpca/nrtl/ul.html About the program (from the OSHA… read more

October 21st, 2014

FDA adds 4th edition of IEC 60601-1-2 to list of EMC consensus standards

On July 9, 2014, the FDA added the 4th edition of IEC 60601-1-2, “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests” to the list of standards that can be used to show EMC compliance for medical electrical devices and systems. … read more

September 18th, 2014

IECEE change requires medical devices to comply with IEC 60601-1-6

Many device manufacturers utilize the CB Scheme to obtain acceptance of test reports and certificates by National Certification Bodies. As such, manufacturers must be familiar with the latest regulatory changes. One such change is the recent requirement for manufacturers of medical electrical equipment to comply with IEC 60601-1-6 (and by extension IEC 62366) as part… read more

May 27th, 2014

EU Requires 60601 with Amendment 1 after 12/31/17

On May 16, 2014 the EU updated the Official Journal for the Medical Device Directive.  One of the updates was to include the EN versions of 60601-1 with Amendment 1.  After 12/31/2017, customers using the 60601-1 standard as a presumption of conformity will need to use the EN 60601-1:2006/A1:2013. For more information on the EU… 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