We offer a full suite of services aimed at helping our customers communicate compliance to the applicable standards and the suitability of their devices for security and use in electrical labs, scientific research labs and factory automation.

As the top NCB under the IECEE CB Scheme category for laboratory and test and measurement equipment, “MEAS”, customers can use the UL CB test report and certificate to receive multiple global certification marks, many of which UL can deliver directly. We can provide integrated test plans that encompass multiple national requirements, reducing rework for global requirements. Simply put, we can test your product in our laboratories to the IEC UL 61010 standard and you can receive approval to use the UL NRTL mark, receive an IECEE CB Test Certificate and even fulfill other local country requirements such as GS and D marks.

With the publication of the third edition of IEC/UL 61010, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use

ECG

electrocardiograph (ECG)An electrocardiograph (ECG) electrode is placed on the skin and used specifically to monitor the electrical activity of the heart by an electrocardiogram or vectorcardiogram versus delivering therapies (defibrillation, pacing, etc.) to patients.

Being relatively lower risk devices, FDA issued a guidance document in 2011 which ultimately provides recommendations for manufacturers to follow that allow ECGs to be classified as exempt from the premarket notification (510(k)) path, saving time and money.

SERVICES

Manufacturers who choose to follow this guidance are required to conduct testing to ANSI/AAMI EC12 “Disposable ECG Electrodes”. Specific tests include:

  • AC impedance
  • DC offset voltage
  • Combined offset instability and internal noise
  • Defibrillation overload recovery
  • Bias current tolerance

WHY UL

Global Market Acceptance

  • 120 year business experience
  • Operates in more than 143 countries
  • UL has issued more CB Test Certificates than any other body
  • UL reports and certifications are recognized and accepted around the world
  • UL Marks appear on more than 22 billion products globally
Comprehensive Testing & Certification Services

  • UL offers field evaluations, onsite training and can come to you for testing
  • Full compliance testing/evaluation to pre-scans and other preliminary testing
  • UL has engineers that work with you from design through conception and production
  • UL’s engineers average 10 plus years in the industry
  • UL has over 11 industries business units in the UL company portfolio

Knowledge of Global Standards and Regulatory Requirements

  • Covers many markets ie FDA (US), MFDS (Korean FDA), EU IVD, EU MDD
  • UL has helped to set more than 1,600 standards defining safety, security, quality and sustainability
  • UL Engineers partner with standard committees such as AAMI, ANSI and government bodies
  • UL has an FDA recognized consensus standard, UL 2900, for cybersecurity
State of the Art Facilities

  • 159 UL laboratories for testing and certification world wide
  • Tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles
  • Over 10 Accredited UL laboratories around the world

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