Title 10

SECTION 35.60

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

§ 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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