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
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.
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
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