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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 Recognition 07/09/2014 
FR Recognition Number 3-129
Standard
ANSI AAMI EC53:2013
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
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§878.4040 Respirator, Surgical Class 2 MSH
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
§870.5310 Over-The-Counter Automated External Defibrillator Class 3 NSA
§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
§870.2910 Transmitters And Receivers, Physiological Signal, Radiofrequency Class 2 DRG
§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
§870.2340 Electrocardiograph Class 2 DPS
§870.2340 Monitor, St Segment Class 2 MLC
§870.2340 Single Lead Over-The-Counter Electrocardiograph Class 2 OEY
§870.2300 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
§870.1025 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
§868.2377 Monitor, Apnea, Facility Use Class 2 FLS
§868.2375 Monitor, Breathing Frequency Class 2 BZQ
§868.2377 Monitor, Apnea, Facility Use Class 2 FLS
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Jeff Silberberg
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-2584
  jeffrey.silberberg@fda.hhs.gov
 Shawn Forrest
  FDA/OMPT/CDRH/ODE/DCD/CDDB/
  301-796-5554
  shawn.forrest@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
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