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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 3-52
ANSI AAMI  EC12:2000/(R)2015
Disposable ECG electrodes
This standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 5.3.2 Pre-attached Leadwire Safety
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Section 5.3.2 conflicts with an existing regulation, see Section 898.12 Performance standard listed below.

Section 5.3.2 conflicts with existing final published guidance, see Section 5 Performance Characteristics listed below.

Section 5.3.2 conflicts with another recognized standard, see ANSI/AAMI EC53 listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.2360 Electrode, Electrocardiograph Class 2 DRX
§882.1320 Cutaneous electrode. Electrode, Cutaneous Class 2 GXY
Relevant FDA Guidance and/or Supportive Publications*
21 CFR 898 Performance Standard for Electrode Lead Wires and Patient Cables.

Class II Special Controls Guidance Document: Electrocardiograph Electrodes - Guidance for Industry and Food and Drug Administration Staff, Issued October 2007.

ANSI/AAMI EC53:2013 ECG trunk cables and patient leadwires.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Loriano Galeotti
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.