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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 056 Date of Entry 06/07/2021 
FR Recognition Number 3-129
ANSI AAMI  EC53:2013/(R)2020
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
Partial recognition. The following part(s) of the standard is (are) not recognized:
-Subclause 5.1.5 Optional labeling to identify accessories as not being DEFIBRILLATION-PROOF

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.

This standard is recognized in part because:

Subclause 5.1.5 is in conflict with other recognized standards, see subclause 201.6.2 and subclause of IEC 60601-2-25 and IEC 60601-2-27.

Subclause 5.3.1 is in conflict with other recognized standards, see subclause 201.6.2 and subclause of IEC 60601-2-25 and IEC 60601-2-27.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 DRT
§870.2300 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class 2 MWI
§870.2300 Low Patient Acuity Monitoring System Class 2 PFY
§870.2340 Electrocardiograph Class 2 DPS
§870.2340 Monitor, St Segment Class 2 MLC
§870.2800 Recorder, Magnetic Tape, Medical Class 2 DSH
§870.2800 Electrocardiograph, Ambulatory, With Analysis Algorithm Class 2 MLO
§870.2800 Electrocardiograph, Ambulatory (Without Analysis) Class 2 MWJ
§870.2900 Cable, Transducer And Electrode, Patient, (Including Connector) Class 2 DSA
§870.2910 Radiofrequency physiological signal transmitter and receiver. Transmitters And Receivers, Physiological Signal, Radiofrequency Class 2 DRG
§870.5300 Dc-Defibrillator, High Energy, (Including Paddles) Class 3 DRK
§870.5300 Dc-Defibrillator, Low-Energy, (Including Paddles) Class 2 LDD
§870.5300 Atrial Defibrillator Class 3 MPC
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
Relevant FDA Guidance and/or Supportive Publications*
1. IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

2. IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)].

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 Contacts
 Loriano Galeotti
 Michael Raccuglia
 Jessica Batista
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.