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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”. The stated objective of this standard is to “provide minimum labeling, safety, and performance requirements that will help ensure safety and efficacy in the clinical use of disposable electrocardiographic (ECG) electrodes”. Specific tests include:
- AC impedance
- DC offset voltage
- Combined offset instability and internal noise
- Defibrillation overload recovery,
- Bias current tolerance.
The guidance document also specifies additional performance characteristics including Biocompatibility (referencing ANSI/AAMI/ISO 10993-1), Adhesive Performance, Shelf Life, Reuse, Electrodes Intended for Use in Specified Procedures (if applicable), Sterility and others.
UL can perform testing and issue a report that manufacturers can use to demonstrate compliance with the FDA guidance document, including the electrical and non-electrical tests. We will work with you to establish the applicable test plan to your needs and schedule and deliver test data you can use to document compliance with the regulations. As a global, third-party, independent and ISO 17025 accredited test lab you will be confident tests were performed accurately in the time frame you need.
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