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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 3-52: AAMI / ANSI EC12:2000/(R)2010, disposable ecg electrodes. (Cardiovascular)

Date of Standard: 2000. 
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:
Disposable ECG Electrodes
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Quality System Regulation
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standards with the following exceptions:

a. The "NOTE" in section 4.1 is not recognized

b. Section 5.3.2 of EC12 is not recognized.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.2360 Electrode, Electrocardiograph Class 2 DRX
Relevant Guidance:
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electrocardiograph Electrodes, issued 10/04/2007
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
 Sharon Lappalainen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 3628
  Silver Spring MD 20993
  301/796-6322
  email: sharon.lappalainen@fda.hhs.gov
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