• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 3-128: AAMI / ANSI / ISO 14117:2012, active implantable medical devices -- electromagnetic compatibility -- emc test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices. (Cardiovascular)

Date of Standard: 2012. 
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
 
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
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 and cardiac resynchronization devices
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 National
Extent of Recognition:
Complete standard
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 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
FDA Technical Contacts:
 Seth Seidman
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 1134
  Silver Spring MD 20993
  301/796-2477
  email: seth.seidman@fda.hhs.gov
 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
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
-
-