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Recognized Consensus Standards

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Recognition List Number: 023 FR Publication Date: 05/05/2010 

Part B: Supplementary Information

Recognition Number 3-77: AAMI / ANSI PC69:2007, active implantable medical devices - electromagnetic compatibility - emc test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators. (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:
Implantable Cardiac Pacemakers, Implantable Cardioverter Defibrillators
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete Standard

This standard specifies test methods appropriate to many interference frequencies, whether high or low, near or far afield. The standard may specify performance limits or require disclosure of performance in the presence of electromagnetic emitters, where appropriate. It provides manufacturers of electromagnetic emitters with information about the level of immunity to be expected from active implantable cardiovascular devices.

ADDITIONAL NOTES:
1. This standard and the conformance of emitters to the relevant human exposure safety standards and pertinent regulatory emission requirements (e.g., those of the U.S. Federal Communications Commission, or FCC). Compliance with biological safety guidelines does not necessarily guarantee EM compatibility with pacemakers and ICDs. In some cases, the reasonably achievable EM immunity performance for pacemakers and ICDs falls below these biological safety limits.

2. The potential for emitter equipment to interfere with a pacemaker or ICD is complex and depends on several factors including: frequency content of the emitter; modulation format; power of the signal; proximity to the patient; coupling factors; and duration of exposure.

3. This standard addresses the EM compatibility of pacemakers and ICDs up to 3,000 MHz and is divided in several sections: a) 0 Hz ? ¿ < 450 MHz; b) 450 MHz ? ¿ < 3,000 MHz; c) ¿ ? 3,000 MHz.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
Unclassified Defibrillator, Implantable, Dual-Chamber Class 3 MRM
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
Unclassified Pulse Generator, Permanent, Implantable Class 3 NVZ
Unclassified Pulse-Generator, Program Module Class 3 LOT
Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO
Unclassified Pulse-Generator, Single Chamber, Single Class 3 LWW
FDA Technical Contacts:
 Mitchell J. Shein
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1316
  Silver Spring MD 20993
  301/796-6363
  email: mitchell.shein@fda.hhs.gov
 Lynn Braddock
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1319
  Silver Spring MD 20993
  301/796-6355
  email: lynn.braddock@fda.hhs.gov
 Seth Seidman
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 1117
  Silver Spring MD 20993
  301/796-2477
  email: seth.seidman@fda.hhs.gov
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