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Recognized Consensus Standards
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Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 3-100: 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 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 monitors
Processes Affected:
510(k)
Type of Standard:
 Vertical, International
Extent of Recognition:
The complete standard is recognized except for 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.

FDA recognition of IEC 60601-2-27: 2005-08, is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-27:2011 Medical electrical equipment ? Part 2-27: 2011 Medical electrical equipment ? Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-27: 2005-08 until June 30, 2013. After this transitional period, declarations of conformity to IEC 60601-2-27 2005-08 will not be accepted.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§870.2340 Electrocardiograph Class 2 DPS
 
Relevant Guidance:
There is no relevant guidance developed at this time.
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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