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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 3-65: AAMI / ANSI EC38:2007, medical electrical equipment - part 2-47: particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. (Cardiovascular)

Date of Standard: 2007. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Ambulatory electrocardiographs
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Quality System Regulation
Type of Standard:
 Test Method & Device Specification, National, Vertical
Extent of Recognition:
Complete Standard (except as noted below).

Clause 4.2.7.1, System noise, is not recognized.
Clause 4.2.7.5, Overall system error, is not recognized.
Clause 5.2.7.5, Overall system error, is not recognized.

NOTE: Cables and leadwires must meet the FDA mandatory standard 21 CFR 898.12.

There is a typographical error in clause 4.2.1.2, Figure 1. The 2 in the unit (G2Hz) should be a subscript.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.2300 Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) Class 2 MWI
§870.2800 Electrocardiograph, Ambulatory, With Analysis Algorithm Class 2 MLO
FDA Technical Contacts:
 Charles Ho, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1318
  Silver Spring MD 20993
  301/796-6320
  email: charles.ho@fda.hhs.gov
 Benjamin C. Eloff, Ph.D
  FDA/CDRH/ODE
  9200 Corporate Blvd., HFZ-450
  Rockville MD 20850
  240/276-4058
  email: benjamin.eloff@fda.hhs.gov
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