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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:
OFFICE OF DEVICE EVALUATION (ODE)
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:
Standard covers electrical, mechanical and other safety characteristics and labeling details important for safety (such as warnings). These parameters and labels must be included in premarket submissions and must be adhered to if devices are exempt from premarket notification.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§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
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2574
  Silver Spring MD 20993
  301/796-6472
  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
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