| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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12-386
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| Standard | |
IEC 63465 Edition 1.0 2026-01
Calibration and quality control in the use of radionuclide calibrators |
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Scope/AbstractThis document specifies the techniques for calibration and usage of pressurised, well-type ionisation chambers for activity measurements of radioactive sources. Such instruments are used to determine the activity, expressed in becquerel (Bq), of photon and some medium to high-energy beta-emitters.
This document addresses calibration procedures of ionisation chambers and radionuclide calibrators to be used by equipment manufacturers, national metrology institutes and designated institutes, radionuclide producers, suppliers, distributors, and end users, like nuclear medicine facilities, industrial or hospital (radio)pharmacies, research laboratories, and nuclear power plants.
This document provides the methods and tests for establishing conformity of device acceptability and maintaining acceptable instrument performance. Performance benchmarks vary depending on the application, so information is given specific to field class instruments for end users and reference class instruments for standards laboratories and instrument manufacturers.
The ionisation chamber or radionuclide calibrator can be an instrument that is used as a standalone device, but it can also be integrated in a much larger appliance, such as a laminar air flow cabinet, a fume hood, a hot cell, or a dispensing unit. The instrument can also be equipped with accessories that are essential for the intended use of the appliance that surrounds and incorporates the radionuclide calibrator. The proper use of each of the accessories can be important for the correct use of the radionuclide calibrator and therefore is part of the scope of this document.
The software and computer system(s) that can be used to control the radionuclide calibrator hardware and functioning are considered an integral part of the device and therefore are also considered part of the scope of this document. |
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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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Transition Period
| FDA recognition of IEC 61303 Edition 1.0 1994-09 [Rec# 12-303], and IEC 61145 (1992-05) [Rec# 12-51] will be superseded by recognition of IEC 63465 Edition 1.0 2026-01 [Rec# 12-386]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-303] and [Rec# 12-51] until July 1, 2029. After this transition period, declarations of conformity to [Rec# 12-303] and [Rec# 12-51] will not be accepted. |
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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. |
