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Electronic Code of Federal Regulations

e-CFR data is current as of June 2, 2020

Title 10Chapter IPart 35Subpart C → §35.60


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart C—General Technical Requirements


§35.60   Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material.

(a) For direct measurements performed in accordance with §35.63, a licensee shall possess and use instrumentation to measure the activity of unsealed byproduct material before it is administered to each patient or human research subject.

(b) A licensee shall calibrate the instrumentation required in paragraph (a) of this section in accordance with nationally recognized standards or the manufacturer's instructions.

(c) A licensee shall retain a record of each instrument calibration required by this section in accordance with §35.2060.

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