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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 3-129
ECG trunk cables and patient leadwires
The objective of this standard is to allow ECG TRUNK CABLES and PATIENT LEADWIRES to be interchanged between ECG DEVICES with isolated PATIENT connections by establishing a common interface between the TRUNK CABLE and the PATIENT LEADWIRE connectors. Performance and safety criteria for TRUNK CABLES and PATIENT LEADWIRES used with isolated PATIENT connectors are also specified. This standard's original scope related to TRUNK CABLES and PATIENT LEADWIRES used with cardiac monitors. The scope was extended to include PATIENT LEADWIRES used with other ECG DEVICES including diagnostic electrocardiographs, ambulatory ECG (Holter) recorders/event recorders and ECG telemetry.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.2800 Electrocardiograph, Ambulatory (Without Analysis) Class 2 MWJ
§870.2800 Electrocardiograph, Ambulatory, With Analysis Algorithm Class 2 MLO
§870.2800 Recorder, Magnetic Tape, Medical Class 2 DSH
§870.2910 Transmitters And Receivers, Physiological Signal, Radiofrequency Class 2 DRG
§868.2375 Monitor, Breathing Frequency Class 2 BZQ
§868.2377 Monitor, Apnea, Facility Use Class 2 FLS
§870.1025 Detector And Alarm, Arrhythmia Class 2 DSI
§870.1025 Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Class 2 MHX
§870.1025 Monitor, St Segment With Alarm Class 2 MLD
§870.2300 Low Patient Acuity Monitoring System Class 2 PFY
§870.2300 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 DRT
§870.2300 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class 2 MWI
§870.2340 Electrocardiograph Class 2 DPS
§870.2340 Monitor, St Segment Class 2 MLC
§870.2340 Single Lead Over-The-Counter Electrocardiograph Class 2 OEY
§870.5300 Atrial Defibrillator Class 3 MPC
§870.5300 Dc-Defibrillator, High Energy, (Including Paddles) Class 3 DRK
§870.5300 Dc-Defibrillator, Low-Energy, (Including Paddles) Class 2 LDD
§878.4040 Respirator, Surgical Class 2 MSH
§868.2377 Monitor, Apnea, Facility Use Class 2 FLS
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
§870.5310 Over-The-Counter Automated External Defibrillator Class 3 NSA
FDA Technical Contacts
 Jeff Silberberg
 Shawn Forrest
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.