This standard specifies the principles and basic requirements for radiation health protection of patients in clinical nuclear medicine. This standard applies to clinical practice where radioactive drugs are used in vivo. GB ​​16361-1996 Radiation Health Protection Standard for Patients in Clinical Nuclear Medicine GB16361-1996 Standard download decompression password: www.bzxz.net

National Standard of the People's Republic of China
Radiological protection standards for the patient in clinical nuclear medicine
Radiological protection standards for the patient in clinical nuclear medicine 1 Subject content and scope of application
This standard specifies the principles and basic requirements for radiological protection of patients in clinical nuclear medicine. This standard applies to clinical practice where radiopharmaceuticals are used in vivo. 2 Referenced standards
GB4792 Basic standards for radiological protection
3 General
GB163611996
3.1 Before determining a nuclear medicine diagnosis or treatment procedure, a justification must be made to ensure that the expected benefits of the nuclear medicine diagnosis and treatment technology to be used according to clinical needs will exceed the potential risks that may be caused by the medical exposure. The applicant physician must master the characteristics and indications of various medical imaging diagnostic technologies. After comparing the various available examination technologies, the method with less risk should be selected according to the actual situation. 3.2 All unnecessary radiation exposure (including errors and repeated examinations) should be avoided. The medical radiation dose given to clinical nuclear medicine patients for legitimate reasons should not exceed the value required to provide the necessary diagnostic information or achieve the treatment purpose. The radiation dose for adults caused by each unit of drug activity in general nuclear medicine examinations is shown in Appendix A (reference). 3.3 The quality assurance of clinical nuclear medicine must be strengthened to ensure the best diagnosis and treatment results from all aspects such as instruments and equipment, facilities, radioactive drugs, diagnosis and treatment techniques, operations and management.
3.4 ​​Special attention should be paid to strengthening protection for patients such as children, breastfeeding women, pregnant women and women of childbearing age. 3.5 All nuclear medicine staff and relevant medical personnel, in addition to having corresponding professional skills, must also master nuclear medicine protection knowledge. Nuclear medicine physicians, physicists and technicians must conscientiously implement quality assurance requirements in their work. 4 Requirements for nuclear medicine diagnosis and treatment units
4.1 Units that carry out nuclear medicine diagnosis and treatment services must pay attention to the allocation of various professional personnel that are suitable for their service items and have a reasonable structure, and at the same time strengthen business training and assessment of relevant staff, including protection knowledge. 4.2 Various laboratories and waiting areas, examination rooms, injection rooms or treatment wards that are compatible with their service items and meet the protection requirements must be available.
4.3 Nuclear medicine diagnosis and treatment equipment, relevant quality control testing equipment and protective equipment that are compatible with the unit's service items and have qualified performance must be equipped.
4.4 It is necessary to pay attention to the provision of medical radionuclide activity meters and calibration sources required for various inspections, and to conduct regular calibration according to the requirements of the national metrology department.
Approved by the State Administration of Technical Supervision on May 23, 1996 and implemented on December 1, 1996
GB 16361-1996
4.5 A nuclear medicine quality assurance plan must be formulated, and a sound quality management system including strengthening patient protection must be established. 5 Responsibilities of relevant staff
5.1 Responsibilities of the applicant physician
5.1.1 The applicant physician shall make correct clinical judgments based on the patient's medical history, physical examination and laboratory test results, and decide whether to submit a corresponding application after comparing various available diagnostic and treatment technologies. 5.1.2 The applicant physician shall state the patient's current medical history and past medical history, other diagnostic and treatment results, the recommended nuclear medicine diagnosis and treatment items and purposes, etc. on the application form.
5.1.3 For female patients of childbearing age, attention should be paid to their possibility of pregnancy, and necessary explanations should be made on the application form. 5.2 Responsibilities of nuclear medicine physicians
5.2.1 When the information provided in the application form for nuclear medicine diagnosis and treatment is incomplete or insufficient to indicate the necessity of nuclear medicine diagnosis and treatment, the nuclear medicine physician has the responsibility to contact the applicant physician, request additional relevant information, and negotiate for proper handling. 5.2.2 For nuclear medicine diagnosis and treatment that is deemed necessary after evaluation, the nuclear medicine physician shall plan for each case according to the specific clinical problem, and select appropriate radioactive drugs with physical and chemical properties, as well as appropriate diagnosis and treatment procedures and techniques. 5.2.3 Nuclear medicine physicians have the responsibility to promptly inform physicians in other clinical departments of new or improved nuclear medicine techniques so that the best available methods can be used to deal with clinical problems.
5.2.4 If the patient has recently undergone a nuclear medicine examination, especially if the patient has undergone the same examination as the one being applied for, the nuclear medicine physician shall determine whether the residual activity from that examination will interfere with the diagnostic quality of the examination being applied for, and take necessary measures. 5.3 Responsibilities of Nuclear Medicine Physicists
5.3.1 Nuclear medicine physicists shall perform quality control on the acceptance, maintenance and use of nuclear medicine instruments and equipment according to the needs of nuclear medicine practice.
5.3.2 Nuclear medicine physicists shall be responsible for the radiation dosimetry and physical and technical aspects of radiation protection in nuclear medicine diagnosis and treatment. 5.4 Technician's Responsibilities
5.4.1 Technicians should carefully check the application requirements and treatment procedures before performing nuclear medicine diagnosis and treatment. If there are any questions, they should ask the relevant personnel in time.
5.4.2 Technicians must measure the activity of the radioactive drugs used; each clinical nuclear medicine practice must be carried out in strict accordance with the corresponding operating procedures.
5.4.3 Before administering radioactive drugs to patients, technicians must carefully check: a. Whether the patient matches the name on the application form; b. Whether the name, chemical form and activity of the radioactive drug to be administered are consistent with the requirements; c. Whether unconventional procedures are to be used;
d. Whether the patient has made preparations, such as fasting or taking blocking agents; e. The order of arranging multiple examinations. 5.4.4 When injecting radioactive drugs into patients, care must be taken to check whether there is leakage around the vein where the radioactive drugs are injected, and whether the prescribed activity has been fully injected. If an accident occurs, the nuclear medicine physician must be reported immediately. 5.4.5 Before giving patients oral radioactive drugs, check whether they can swallow them normally. When taking drugs, observe whether the drugs have been swallowed and observe whether the patients have any signs of vomiting. 5.4.6 All circumstances of each administration of radioactive drugs (including patient reactions and side effects, etc.) must be recorded. If the administration is unsatisfactory, the reasons for failure should also be recorded.
5.4.7 Preventive measures should be established to avoid giving wrong radioactive drugs or giving radioactive drugs to wrong patients. If a treatment administration error occurs, the nuclear medicine physician should immediately treat the patient properly and report to the relevant departments. 5.4.8 After completing radionuclide imaging, a nuclear medicine physician must be invited to conduct a review. 144
6 Principles of protection of special patients in nuclear medicine diagnosis GB16361-1996
6.1 When applying for nuclear medicine examinations for women of childbearing age, whether they are pregnant should be considered and the indications should be strictly followed. If the menstruation has expired or stopped when the examination is requested, it should generally be regarded as pregnancy. 6.2 There must be a legitimate reason for performing nuclear medicine examinations on pregnant women. In particular, examinations involving radiopharmaceuticals that can be transported across the placenta and enter fetal tissues must be controlled.
6.3 Nuclear medicine examinations of breastfeeding women
6.3.1 Whether to perform nuclear medicine examinations on breastfeeding women should be balanced between the risk of radiation exposure to infants fed with human milk and the benefit of timely diagnosis and treatment of the mother's disease. 6.3.2 Unless absolutely necessary, nuclear medicine examinations involving radiopharmaceuticals in breastfeeding women should generally be postponed. 6.3.3 If breastfeeding women undergo nuclear medicine examinations, the time to suspend breastfeeding should be determined based on the secretion of the radiopharmaceuticals in breast milk. Appendix B (reference) is available for reference.
6.4 Nuclear medicine examinations of children
6.4.1 Nuclear medicine physicians must pay attention to determining the optimal dosage of radiopharmaceuticals based on actual clinical needs and the weight and body surface area of ​​the child. 6.4.2 Nuclear medicine examinations on children should be conducted in collaboration with pediatricians, and effective sedation methods and various immobilization measures can be used cautiously during the examination according to the situation.
7 Principles of patient protection in nuclear medicine treatment
7.1 Whether to use radionuclide treatment for patients should be comprehensively weighed based on the risks caused by the disease and the risks of radiation damage.
Special attention should be paid to assessing the potential benefits and risks of pediatric patients. When applying for radionuclide treatment for women of childbearing age, it should be considered whether they are pregnant. 7.2 Pregnant women are generally not suitable for radionuclide treatment. When it is necessary to use it under special circumstances, termination of pregnancy should be considered. 7.3 To determine the use of radionuclide treatment, the treatment dose must be designed on a case-by-case basis based on the characteristics of the treatment and clinical needs. 7.4 A small number of tests can be used to obtain information on the distribution and metabolism of radionuclides in the body to better help formulate treatment plans. 7.5. For women of childbearing age who are receiving treatment, the control limit for whether they can attempt to become pregnant is that the radioactive drugs remaining in their bodies will not cause the embryo to be irradiated with an absorbed dose of about 1 mGy. For example, women of childbearing age who are treated for hyperthyroidism with 1311 generally need to wait for 6 months before they can become pregnant. Breastfeeding women should stop breastfeeding for a certain period of time after receiving radionuclide treatment. 145
Radioactivity of organs examined
Organ or function
Thyroid
(+gall bladder)
GB16361—1996
Appendix A
Radiation dose for adults per unit of administered activity in general nuclear medicine examinations (reference)
Radioactivity
Phosphonates
O-iodine
Sodium urate
O-iodine
Sodium urate
Periodine
(no blocking)
Iodide
(35% absorption)||tt| |Iodide
(35% uptake)
(Large)
Nanospheres
(Without carrier)
Organ 1
Most irradiated organ, mGy/MBq
Organ 2
(Bone surface)
2.3E—02
(Bladder)
(Bladder)
(Bladder)
(Bladder)
(Kidney)
6.2E—02
(Upper large intestine)
(Thyroid gland)
(Thyroid gland)
7.7E—02
(Spleen)
(Spleen)
1.1E—01
(Gallbladder)
(Liver)
(Urinary bladder)
(Uterus)
1.7E—02
(Uterus)
(Uterus)
7.9E—03
(Uterus)
(Urinary bladder)
(Sky)
(Stomach)
(Sky)
7.4E—02
(Liver)
7.4E—02
9.2E—02
(Upper Large intestine)
(adrenal gland, pancreas)
Organ 3
9.6E—03
(bone marrow)
(kidney)
7.3E—03
(lower large intestine)
3.0E—02
(kidney)
4.4E—03
(kidney)
(adrenal gland, spleen)
(thyroid gland)
(bladder)
(bladder)
(pancreas)
1.5E—02
bone marrow)
6.2E—02
(Lower large intestine)
(Kidney)
Fetal body irradiation
mGy/MBg
6.1E—03
2.8E—03
3.5E—02
7.9E—03
8.1E—03
5.0E—02
1.9E—03
1.3E—02
Effective dose
mSv/MBq
6.6E—02
1.3E—02
1.5E—01
1-4E-02|| tt||2.4E—02
1.8E+005.8E+00
Radioactivity examined
Organ or function
Radioactivity
High salt
(blocking thyroid)
DTPA (lumbar spine)
Gluconate/
Gluceptate
Aerosol
(fast clearance)
(slow clearance)
Gas, 5min
(repeated breathing)
Gas, 30s
-one inhalation)
Thallium ions
Red cells Cells
Leukocytes
Citrate
Organ 1
GB16361—1996
Continued Table A1
Organs most irradiated, mGy/MBq
Organ 2
(Bladder)
4.6E—02
(Spinal cord)
5.6E—02
(Bladder)
(Bladder)
(Lung)
4.7E—02
(Bladder)
(Lung)
1.1E—03
(Lung)||t t||(Lung)
2.1E—04(Lung)
(Testis)
(Spleen)
(Bone surface)
(Uterus)
2.9E—02
(Bone marrow)
4.9E—02
(Kidney)
(Heart)
1.6E—02
(Liver)
(Lung)
(Bladder)
(Bone marrow)
(Bone surface, bone marrow, mammary gland)
(Mammary gland)
(Kidney)
(Spleen)
7. 1E- 01
2.0F—01
(lower large intestine)
Organ 3
4.7E—03
(kidney, ovary)
(kidney, bladder)
(uterus)
2. 6E--02
(brain)
1.0E—02
(bladder)
(uterus)
6.4E—03
(breast)
8.3E—04
(breast)
1.1E—04
(small and large intestine, liver,
|pancreas, spleen, uterus)
(lower large intestine)
1.4E—02
(lung)
6.9E—01
(bone marrow)
1.9E—02
(bone marrow)
fetal irradiation
mGy/MBg
4.5E—03||t t||7.7E—03
2.4E—03
5.9E—03
1.7E—03
1.3E—07
4.7E—03
Effective dose
mSv/MBq
5.3E—03
1.1E—02
9.0E—03
2.7E—02
7.0E—03
1.5E—02
1.2E—01
Examined organ radioactivity
Organ or function
Adrenal gland
Digestive tract
Radioactivity
Fibrinogen||tt ||(Complete
Thyroid blockade)
Platelets
Platelets
Methionine
Methylcholesterol
Deformed erythrocytes
Pertechnetate
(Daily use, without
blocking agent)
Organ 1
GB16361—1996
Continued Table A1
Organs most exposed to radiation, mGy/MBq
Organ 2
(Heart)
(Spleen)
(Spleen)
(Adrenal glands)
(Liver)
(Spleen)
(Upper large intestine)
(Spleen)
7.3E—0 1
(liver)
(hip)
5.9E—01
(bladder)
3.0E—01
(pancreas )
(Stomach)
Organ 3
2.3E—01
(Lung)
6.6E—01
(Pancreas)| |tt||1.9E—01
(bone marrow)
(spleen)
(small intestine, pancreas,
uterus, bone marrow)
(spleen)
(liver)
(small intestine)
Fetal irradiation
mGy/MBq
5.5E—02
9.5E—02
2.8E—02
7.7E—02
Effective dose
mSv/MBq
Note: ①This table is quoted from the International Commission on Radiological Protection (ICRP) Publication No. 52, "Patient Protection in Nuclear Medicine". For more information, please refer to ICRP Publication No. 53, "Radiation Dose Received by Patients from Radioactive Drugs", which collects radiation dose data of patients caused by various types of radioactive drugs in detail.
②The abbreviated drug names in the table are: EDTA-
ethylenediaminetetraacetic acid; DTPA
dithiodiaminepentaacetic acid, DMSA-
dimercaptobutyric acid:
HIDA—N-2,6-dimethylacetoanilide iminodiacetic acid; FDG--2-deoxy-2-fluoro-D-glucose; MAA-segregated albumin; MIBG-——
-meta-iodofuranguanidine.
③The dose values ​​in the table are all given in exponential form, for example: 6.3E-02-6.3×10-2; 5.0E+025.0×102. Appendix B
Classification of radiopharmaceuticals that affect lactation
(reference)
Lactating women who use the following radiopharmaceuticals should stop breastfeeding for at least 3 weeks: B1
Large particle poly
All 1311 and 1251 radiopharmaceuticals except labeled sodium o-iodine hippurate; 22Na, 67Ga, 201T1, 75Se-methionine radiopharmaceuticals.
B2Lactating women who use the following radiopharmaceuticals should stop breastfeeding for at least 12 hours: 131I-, 125I-, and 123I-sodium o-iodine hippurate; all \Tc compounds except labeled red blood cells, phosphates and DTPA. B3Lactating women who use 99Tc-red blood cells, phosphates and DTPA radiopharmaceuticals should stop breastfeeding for at least 4 hours. 148
GB16361—1996
Women who are breastfeeding and taking ICr-EDTA radiopharmaceuticals do not need to stop breastfeeding. B4bzxz.net
Additional Notes:
This standard was proposed by the Ministry of Health of the People's Republic of China. This standard was drafted by the Institute of Radiation Medicine, Chinese Academy of Medical Sciences. The main drafters of this standard are Zheng Junzheng and Lu Zhengfu. This standard is interpreted by the Ministry of Health's Industrial Hygiene Laboratory, the technical unit entrusted by the Ministry of Health. 1.19
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