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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 4-187: IEC 60601-2-18: Edition 3.0 2009-08, medical electrical equipment - part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment. (Dental/ENT)

Date of Standard: 2009. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Endoscopes and accessories (but not including laser accessories)
Processes Affected:
510(k), PMA, PDP, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§874.4350 Source, Carrier, Fiberoptic Light Class 1 EQH
§874.4680 Bronchoscope (Flexible Or Rigid) Class 2 EOQ
§874.4710 Esophagoscope (Flexible Or Rigid) Class 2 EOX
§874.4720 Mediastinoscope, Surgical Class 2 EWY
§874.4750 Laryngostroboscope Class 1 EQL
§874.4760 Nasopharyngoscope (Flexible Or Rigid) Class 2 EOB
§874.4770 Otoscope Class 1 ERA
FDA Technical Contact:
 Susan F. Rudy
  10903 New Hampshire Avenue Building 66, Room 2574
  Silver Spring MD 20993
  email: susan.rudy@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