Skip to main content
  • Feature Story

UL Northbrook expands CBTL scope with 3 additional IEC 60601 Medical Particular Standards for use with IEC 60601

October 24, 2016

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 heating in medical use
  • ISO 80601-2-56:2009 Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
  • ISO 80601-2-61:2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

These standards are used in conjunction with the base standard IEC 60601-1:2005 (3rd edition) “Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.”  ISO 80601-2-56:2009 and ISO 80601-2-61:2011 are both listed as U.S. FDA Consensus standards.

Get in touch

Have questions, need specifics? Let's get this conversation started.

Help and support

How can we help?