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Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 12-272: IEC 60601-2-17 Edition 3.0 2013-11, medical electrical equipment - part 2-17: particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment. (Radiology)

Date of Standard: 2013. 
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:
Remote Controlled Radionuclide Applicator Systems
Processes Affected:
510(K), PMA, PDP, IDE, HDE
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard

FDA recognition of IEC 60601-2-17 (2004) [Rec#12-146] will be superseded by recognition of IEC 60601-2-17 Edition 3.0 2013-11 [Rec#12-272]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec#12-146] until August 1, 2016. After this transition period, declarations of conformity to [Rec#12-146] will not be accepted.
Related CFR Citations and Product Codes:
Device Name Device
§892.5700 System, Applicator, Radionuclide, Remote-Controlled Class 2 JAQ
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
 John Chen
  10903 New Hampshire Avenue WO66 RM4260
  Silver Spring MD 20993
  email: john.chen@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