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Recognized Consensus Standards

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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
Standard
ANSI AAMI EC53:2013/(R)2020
ECG trunk cables and patient leadwires
Scope/Abstract
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

-Subclause 5.3.1 Non-DEFIBRILLATION-PROOF TRUNK CABLES and PATIENT LEADWIRES
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 201.4.3.101 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 201.4.3.101 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
§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
§870.2900 Cable, Transducer And Electrode, Patient, (Including Connector) Class 2 DSA
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)].
FDA Technical Contacts
 Loriano Galeotti
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA
  301-796-5279
  Loriano.Galeotti@fda.hhs.gov
 Michael Raccuglia
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA
  301-796-0008
  Michael.Raccuglia@fda.hhs.gov
 Jessica Batista
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA
  301-796-7183
  Jessica.Batista@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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