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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 3-101: AAMI / ANSI / IEC 60601-2-27:2011, medical electrical equipment - part 2-27: particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. (Cardiovascular)

Date of Standard: 2011. 
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 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:
Electrocardiographic monitor
Processes Affected:
510(k), PMA, IDE, HDE, PDP, Quality System Regulation
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard, except the following:
*Any reference to IEC 60601-1:2005 (i.e. the 3rd edition of 60601-1). FDA recognizes the ANSI/AAMI ES60601-1:2005 standard instead.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.2300 Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class 2 DRT
FDA Technical Contact:
 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
* 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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