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.