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Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 3-106: AAMI / ANSI / IEC 60601-2-25 Edition 2.0 2011-10, medical electrical equipment - part 2-25: particular requirements for the basic safety and essential performance of electrocardiographs. (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:
Electrocardiographs
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard for SAFETY ONLY (Including Protection Against Electric Shock Hazards) for Type CF EQUIPMENT or APPLIED PART

(Note: Standard is NOT applicable for equipment labeled and tested as Type B or BF EQUIPMENT or APPLIED PART).

Therefore, Clause 201.7.9.2.101 a)2) of the particular standard applies to only type CF electrocardiographs, not Types B or BF.

Clauses 201.12.1.101.2, 201.12.1.101.3.1 and 201.12.1.101.3.2 in the particular standard are not recognized.
Clause 201.8.5.5.1 of the particular standard is not recognized.

Clause 201.8.5.2.3 of the particular standard is not recognized (SEE 21 CFR 898).

NOTE: FDA may request performance data since the IEC particular standard only deals with safety.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.2340 Electrocardiograph Class 2 DPS
FDA Technical Contacts:
 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
 Frank Lacy
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1236
  Silver Spring MD 20993
  301/796-6321
  email: frank.lacy@fda.hhs.gov
 Linda Ricci
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1246
  Silver Spring MD 20993
  301/796-6325
  email: linda.ricci@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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