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

Part B: Supplementary Information

Recognition Number 12-252: IEC 60601-2-65 Edition 1.0 2012-09, medical electrical equipment - part 2-65: particular requirements for the basic safety and essential performance of dental intra-oral-x-ray equipment. (Radiology)

Date of Standard: 2012. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID)
(2)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Dental extraoral source x-ray equipment
Processes Affected:
510(k), PMA, Device Evaluation, Radiological Health Regulations
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard.

Transition
FDA recognition of IEC 60601-2-7 (1998) and IEC 60601-2-32 Ed. 1.0 (1994) is hereby superseded, as applicable, by recognition of IEC 60601-2-65 Edition 1.0 2012-09, Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60601-2-7 (1998) and IEC 60601-2-32 Ed. 1.0 (1994) until December 31, 2013. After this transitional period, declaration of conformity to IEC 60601-2-7 (1998) and IEC 60601-2-32 Ed. 1.0 (1994) will not be accepted.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.1800 System,X-Ray,Extraoral Source,Digital Class 2 MUH
§872.1800 Unit, X-Ray, Extraoral With Timer Class 2 EHD
FDA Technical Contact:
 Robert Sauer
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room G246
  Silver Spring MD 20993
  301/796-3580
  email: robert,a,sauer@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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