Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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003
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Date of Entry 07/12/1999
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FR Recognition Number
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12-51
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Standard | |
IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides |
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Scope/AbstractThis International Standard covers the techniques for the quantification of the activity of identified radionuclides using any of a variety of ionization chambers currently available for this purpose. The application of the standard is limited to instruments that incorporate well-type ionization chambers as detectors.
This standard provides a method for obtaining measurements that are accurate to within ±10 % and reproducible to within ±5 % (usually for sources of more than 3,7 x 10 6 Bq (100 pCi)).
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§892.1360 |
Radionuclide dose calibrator.
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: Guidance for the Submission of Premarket Notification for Radionuclide Dose Calibrators, Issued November 20, 1998
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |