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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 3-102: IEC 60601-2-31 Edition 2.1 2011-09, medical electrical equipment, part 2-31: particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source. (Cardiovascular)
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  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:
External Cardiac Pacemakers with Internal Power Source & consisting of a Non-implantable Pulse Generator & patient cables.

This Does NOT include pacing leads or other equipment for cardiac stimulation which either:

1) forms an integral part of equipment with other functions (e.g., pacing system analysis);
2) applies the stimulus across the thorax externally or in the esophagus; or
3) provides antitachycardia therapy beyond high rate burst pacing; or
4) provides bi-ventricular pacing
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard for Safety

NOTE: FDA may request data demonstrating the device's ability to perform in accordance with its design specification since the IEC particular standard only deals with safety.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.2900 Cable, Transducer And Electrode, Patient, (Including Connector) Class 2 DSA
§870.3600 Pulse Generator, External Pacemaker, Dual-Chamber Class 3 OVJ
§870.3600 Pulse-Generator, Pacemaker, External Class 3 DTE
Relevant Guidance:
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator (10/17/2011)
FDA Technical Contact:
 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
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