Disclaimer: This information is only provided as a guide. Regulations may change and you should consult the Code of Federal Regulations (CFR) or your agreement state regulations for the most accurate information.
The regulations in this part establish standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the Nuclear Regulatory Commission. These regulations are issued under the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended.
It is the purpose of the regulations in this part to control the receipt, possession, use, transfer, and disposal of licensed material by any licensee in such a manner that the total dose to an individual does not exceed the standards for protection against radiation prescribed in the regulations in this part. However, nothing in this part shall be construed as limiting actions that may be necessary to protect health and safety (10 CFR 20.1001).
Activity is measured in Ci or mCi.
The relationship between activity and exposure is governed by the following equation:
Total Exposure ( Roentgens ) = G. A. t. e -ux /d2
Plan activities to take advantage of Time, Distance and Shielding.
Absorbed Dose is the energy deposited by ionizing radiation per unit of mass. Absorbed Dose is measured in Rads.
1 Roentgen = 0.869 Rads in Air.
Dose Equivalent ( Rem ) = Absorbed Dose ( Rads ) x QF x N
QF - Quality Factor related to linear energy transfer.
N - modifying factor dependent on energy & tissue.
1 Sievert ( Sv ) = 100 Rems.
The use of radiation and radiolabeled products for any purpose is governed by regulatory agencies.
General license :
Specific license of limited scope :
Specific license of broad scope :
Regulate nuclear pharmacy practice such as preparation and dispensing.
Grant professional licenses to pharmacists and technologists.
The National Council on Radiation Protection recommends that radiation doses are not to exceed the maximum limits summarized in table 1. ALARA program is to maintain exposures to radiation as low as possible below the dose limits recommended.
NCRP Report No. 116
Table 1 - Summary of recommendations
A. Occupational exposures
1. Effective dose limits
a) Annual 50 mSv
b) Cumulative 10 mSv x age
2. Equivalent dose annual limits fortissues and organs
a) Lens of eyes 150 mSv
b) Skin, hands and feet 500 mSv
B. Public exposures ( annual )
1. Effective dose limit, continuous or frequent exposure 1 mSv
2. Effective dose limit, infrequent exposure 5 mSv
3. Equivalent dose limits for tissues and organs
a) Lens of eye 15 mSv
b) Skin, hands and feet 50 mSv
C. Education and training exposures ( annual )
1. Effective dose limit 1 mSv
2. Equivalent dose limit for tissues and organs
a) Lens of eye 15 mSv
b) Skin, hands and feet 50 mSv
D. Embryo - fetus exposures ( monthly )
1. Equivalent dose limit ` 0.5 mSv
E. Negligible individual dose ( annual ) 0.01 mSv
F. Minors occupational dose limits ( annual ) 10% of adults
( 10 CFR 20.1201 ).
I. The licensee shall make surveys that may be necessary to comply with the regulations.
a. Survey all areas where radiopharmaceuticals are prepared at the end of each day.
b. Weekly survey of areas where radiopharmaceuticals or radioactive wastes are stored.
c. Weekly wipe testing of areas where radiopharmaceuticals are prepared or stored.
d. Establish radiation dose rate trigger levels for each area surveyed
e. Areas should be surveyed with G. M survey meter.
f. Records should be retained for 3 years ( 10 CFR 35.51 ).
Calibration of survey instruments:
Check of survey instruments:
II. Dose Calibrators: The licensee shall ensure that instruments and equipment used for quantitative radiation measurements are calibrated and checked periodically for the radiation measured (Dose Calibrators).
III. Well Counters SCA & MCA should be checked daily with a long-lived standard source such as Cs- 137 due to possible drift in electronics.
IV. All personnel dosimeters must be evaluated periodically ( 10 CFR 20.15 ).
Caution Signs: standard radiation symbol has three bladed design and shall use the colors magenta or purple on yellow background (10 CFR 20.1901 ).
Classification of radiation areas
1. Unrestricted Areas
2. Restricted Areas
3. Controlled Areas
These words and the radiation symbol are used in areas as follows:
1. Caution: High Radiation signs if
2. Caution: High Radiation Area signs if
3. Caution: Very High Radiation area signs if
DOT requires that each package containing radioactive material should bear clearly visible label bearing the radiation symbol and the words Caution Radioactive Material . The label must also provide sufficient information as:
1. The radionuclide(s) present.
2. Estimate of the quantity of radioactivity.
3. The date for which the activity is estimated.
4. Radiation level ( 10 CFR 20.1902 ).
Label Type Surface Reading TI Reading at 1 m.
|White I||0.5 mR||<Bkg|
|Yellow II||0.5 - 50 mR||<1 mR / hr|
|Yellow III||50 - 200 mR||1 - 10 mR / hr|
(49 CFR 172.403).
Receiving radioactive Packages
Package Check-In should be done
The following data should be recorded on the receipt book
Shipping Radioactive packages
1. Shield syringes or vials containing radiopharmaceuticals
2. Label and include the name of the radiopharmaceutical, the procedure to be performed, and the patient name.
3. Use syringe shield when handling the dose.
4. Wipe test the dose to detect any contamination.
5. Place the appropriate DOT label on the shipping container with detailed information about the radionuclides and their radiation level before shipping. Add shielding if surface reading exceeds 200 mR / hr ( 10 CFR 35.60 ).
Keep for 3 years
Keep for 5 years
Keep for duration of use
Keep indefinitely (10 CFR 20.2101-10).
Radiopharmaceutical ( RP ) Dosage Assay
IF THE FOLLOWING HAPPENS!
NOTIFY THE NRC BY THE NEXT CALENDAR DAY
NOTIFY THE MD WITHIN 24 HR.
SEND A WRITTEN REPORT TO NRC, MD, AND THE PATIENT WITHIN 15 DAYS WITH DESCRIPTION, ACTION TAKEN , EFFECT ON PATIENT.