GBZ 134-2002 Standard for health protection of radionuclide dressing therapy
Some standard content:
Ics13.100
National occupational health standard of the People's Republic of China GBZ134-2002
Radiological protection standard forradionuclideapplicatortherapy2002-04-08Promulgated
Ministry of Health of the People's Republic of China
Implementation on June 1, 2002
Normative referenced documents
3 Terms and definitions
Hygiene protection requirements for radionuclide applicator therapy5
Special protection requirements for 32P applicators
6 Hygiene protection requirements for source storage boxes
Hygiene protection requirements for applicator therapy rooms
Hygiene protection requirements for applicator therapy
9 Hygiene protection testing for applicator therapy
Appendix A (Normative Appendix) Characteristics of commonly used radionuclidesAppendix B (Informative Appendix) Reference method for making 32P simple applicatorsAppendix C (Informative Appendix)
Shielding materialsβ particle range
This standard is formulated in accordance with the "Law of the People's Republic of China on the Prevention and Control of Occupational Diseases". As of the date of implementation of this standard, the original standard WS179-1999 will be invalidated at the same time.
Chapters 4 to 9 and Appendix A of this standard are mandatory appendices, and the rest are recommended contents. In order to strengthen the radiation health protection and supervision and management of clinical radionuclide dressing therapy, and to protect the health and safety of professional staff, patients and the public. This standard is formulated based on a comprehensive investigation and research on the clinical application and health protection status of radionuclide dressing therapy in some provinces and cities, and with reference to relevant domestic and foreign materials. The main contents of this standard are the health protection requirements for radionuclide dressing therapy devices, the health protection requirements for source boxes, the health protection requirements for dressing therapy rooms, and the health protection requirements for dressing therapy. Appendix A of this standard is a normative appendix.
Appendix B and Appendix C of this standard are informative appendices. This standard is proposed and managed by the Ministry of Health.
Drafting unit of this standard: Institute of Radiation Medicine, Shandong Academy of Medical Sciences. The main drafters of this standard: Deng Daping, Zong Xiyuan, Hou Jinpeng, Zhu Jianguo, Qiu Yuhui. This standard is interpreted by the Ministry of Health.
Health protection standard for radionuclide patch therapy 1 Scope
GBZ134-2002
This standard specifies the requirements for radiological health protection of radionuclide patch therapy devices, source boxes, treatment rooms and the implementation of patch therapy, as well as the content and methods of radiological protection detection. This standard applies to the practice of patch therapy for skin and ophthalmic diseases using sealed radionuclide patch therapy devices.
2 Normative references
The following documents become clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties to an agreement based on this standard are encouraged to study whether the latest version of this document can be used. For any undated referenced document, the latest version shall apply to this standard. GB2894 Safety signs
GB4075 Classification of sealed radioactive sources
GB4076 General provisions for sealed radioactive sources
3 Terms and definitions
The following terms and definitions apply to this standard. 3.1
Applicator therapy
A contact radiation therapy method that selects an appropriate radionuclide surface source as an applicator to cover the surface of the patient's lesion and irradiate for a certain period of time to achieve the purpose of treatment. 3.2
Radionuclide applicator Radionuclide applicator A radionuclide with a certain activity and energy is sealed in a certain way to form a surface source with different shapes and areas, which is used as a radiation source for applicator therapy, referred to as an applicator or applicator source. 3.3
Source storage chest
A container for storing radionuclide applicators that has fireproof, anti-theft and radiation-proof properties. Including the source storage device for transportation and the source storage box for storing the application source in the treatment room. 3.4 Source surface absorbed dose rate source surface absorbed dose rate The air absorbed dose rate generated by the sheet radiation source in the radionuclide applicator on the surface of the entire effective area of the applicator (mGy.min).
4 Hygienic protection requirements for radionuclide applicator 4.1 Radionuclides should be selected with a long half-life, high beta ray energy, no gamma radiation or only low-energy gamma radiation, such as "Sr-" Y and P applicators. Their characteristics are shown in Appendix A (Normative Appendix).
4.2 Radionuclide applicators must have the instructions and inspection certificate of the manufacturer or maker, and should have the production batch number and inspection certificate number. The instructions should state the applicator number, nuclide name and chemical symbol, radiation type and energy, radioactivity, source surface irradiation dose rate, surface radioactive contamination and leakage detection, detection date, instructions for use and the name of the production unit. 4.3 In addition to the source foil, source shell, source surface protection film, aluminum alloy protection ring frame and source cover, the commercial applicator must also have a protective screen and handle or other fixing devices. The safety classification of the applicator should meet the requirements of GB4705. 4.4 The applicator source must be tightly packaged and the recommended service life must be specified. Those that have exceeded the service life or the surface contamination exceeds the standard or are suspected of leakage should be sent back to the production unit for inspection and repair before determining whether they can continue to be used. 4.5 Before the applicator source is put into clinical use, except for the P applicator, there must be measurement data of the source surface irradiation uniformity and the source surface air absorption dose rate or the reference point air absorption dose rate approved by the statutory metrology agency, with a total uncertainty of no more than 7%, and a dose verification certificate attached. 4.6 Ophthalmic applicators can be made into different shapes (such as round, boat-shaped, semicircular) according to the needs of the lesion, or protective covers with windows of the above different shapes can meet the needs of treating different corneal and conjunctival lesions. 4.7 If the half-life of the radioactive nuclide used in the applicator is more than one year, the discarded applicator should be sealed in the laboratory or sent to the manufacturer for disposal.
5Special protection requirements for P applicators
5.1\The production unit of the P applicator must hold a license for radioactive isotope work issued by the provincial government health administrative department, and the maker must be a radiation work professional. 5.2\The production unit of the 3P applicator must be equipped with an activity meter and a beta contamination checker, and have special tools for making P applicators.
5.3\The walls, floors and work surfaces of the production room of the P applicator should be covered with materials that are easy to remove contamination. 5.4\The production of the 3P applicator should be carried out in a fume hood, and the maker should wear latex gloves. For the production method, please refer to Appendix B (Informative Appendix).
5.5 During the production of the 3P applicator, the dose should be accurately calculated according to the shape of the lesion, and the dose on the source surface should be evenly distributed; and it should be sealed with three layers of high-quality plastic film and tape to ensure its sealing. The applicator should be used only after the surface is tested for radioactive contamination.
5.6 During treatment, it must be operated by medical staff, and the side that does not contact the patient's skin should be covered with a 3mm thick rubber shield.
5.7 The number, activity, and usage of homemade P applicators should be registered. After use, the 32P applicator should be counted by medical staff and handed over to the production unit for recycling and processing, and records should be made. 6 Sanitary protection requirements for source boxes
6.1 The outer surface of the source box must be marked with the name of the radionuclide, the maximum allowable loading radioactivity, and a firm and eye-catching ionizing radiation warning sign (see GB2894). 6.2 The shielding layer structure of the source box must be divided into two layers, inner and outer. The inner layer is made of low atomic number materials such as aluminum or organic glass, and its thickness must be greater than the maximum range of beta radiation in the corresponding material, see Appendix C (Informative Appendix). The outer layer is made of heavy metal materials such as lead and cast iron with appropriate thickness. It also has fireproof and anti-theft properties. 6.3 The source box must be able to be locked on a fixed object to prevent theft. The air absorption dose rate of material radiation at 5cm and 100cm from the surface of the source box shall not exceed 10μGy·h and 1μGy·h respectively. 7 Hygienic protection requirements for dressing treatment rooms
7.1 The dressing treatment room must be separated from the diagnosis room, registration duty room and waiting room. The usable area in the treatment room should not be less than 10m.
7.2 The shielding thickness of the walls and protective doors of the treatment room should comply with the principles of radiation protection to ensure that the exposure dose of people outside the workplace is below the corresponding annual dose limit. 7.3 The walls below 1.5m in height in the treatment room should have a protective coating that is easy to decontaminate. The floor, especially where the patient is being treated, must be covered with replaceable soft and easily decontaminated materials. 7.4 The patient seats in the treatment room should be kept 1.2m apart or protected by appropriate materials and thickness.
7.5 The treatment room must formulate radiotherapy operation procedures and health management system, and be equipped with detection instruments such as beta contamination detectors.
7.6 The treatment room should be equipped with special cleaning facilities and tools, and must not be mixed with non-treatment rooms. 8 Hygiene protection requirements in patch therapy
8.1 Patch therapy should adhere to the principles of practice justification and protection optimization. A quality assurance plan must be formulated and implemented to ensure accurate treatment doses, so that the treatment lesions can obtain a reasonable dose and its distribution, and the irradiation range and dose of normal tissues can be minimized. 8.2 Before implementing patch therapy, the treatment date, the number of the patch source used, the radiation type, activity, irradiation site and area must be registered in detail, and a treatment card with items such as the patient's name, gender, age, address, diagnosis and number of irradiations must be issued.
8.3 Before each treatment, the patient's treatment card is collected first, and then the patch therapy is implemented. After the treatment is completed, the applicators are collected in full and then the treatment card is issued. The staff will collect the applicators and put them back in the source storage box for storage. 8.4 Before treatment, design a reasonable treatment plan according to the location, shape, area, degree of lesions, effective area of the treatment source and the air absorption dose rate of the source surface, and accurately calculate the fractional irradiation dose (time) and cumulative irradiation dose (time) of the treatment course.
8.5 It is strictly forbidden to take the dressing source out of the treatment room during the application of patch therapy. 8.6 During the treatment, the surrounding normal tissue must be shielded with 3mm thick plasticine or rubber sheet. For lesions in the facial area, shield the surrounding normal skin; for lesions in other parts, expose 0.5cm of normal skin around the lesion. After covering the surrounding shielded skin with a piece of cellophane or plastic film, stick the applicator tightly to the lesion.
8.7 During the application of patch therapy, if the irradiation time is long, it can be fixed with adhesive tape, and the benefactor or accompanying personnel can help press the applicator. If the irradiation time is short, the treatment staff can press and fix the applicator personally. If conditions permit, special devices can be used for remote operation.
8.8 The applicator must be regularly calibrated for decay to adjust the irradiation dose. During each treatment, a dedicated person should use a timer with an alarm to control the irradiation time. During the treatment, the treatment response and the treatment of the lesion should be closely observed, and the irradiation dose should be adjusted in time to prevent complications. 8.9 During the application treatment, medical staff should take effective personal protection measures, such as wearing plexiglass glasses or masks and using long-distance operation tools as much as possible. 8.10 When operating the applicator, the source surface must not be facing people, and the source surface must not be looked directly at. 8.11 When using the applicator, avoid sharp objects damaging the source window surface. The applicator must not be immersed in water, alcohol or other solvents, and should be stored in a dry place after use
8.12 The maximum allowable application area at one time should not exceed 200cm for adults, 100cm for children, and should be reduced as appropriate for infants and young children.
9 Health protection inspection for patch therapy
9.1 Acceptance inspection
Before the newly purchased or repaired applicator is officially used in clinical practice, it must be inspected by the radiation health technical service agency. The acceptance inspection items are as follows: a) Inspection of the surface integrity of the applicator source window and leakage of radioactive materials; b) Inspection of the radiation uniformity of the applicator source surface; c) Inspection of the air absorption dose rate on the applicator source surface or the air absorption dose rate at the reference point; d) Inspection of the effective activity of the applicator and the decay correction of the source surface absorption dose rate; e) Inspection of the air absorption dose rate at 5 cm and 100 cm from the surface of the source storage box; f) Inspection of the β and γ radiation levels in the patch therapy room, and the radioactive contamination of the ground and the surface of the treatment equipment; g) Inspection of the timing error of the patch therapy timer. 9.2 Regular Inspection
During clinical application, the items and cycles that should be regularly inspected are as follows: a) Items a), b), c), e) and g) in Article 9.1, 90Sr-90Y application source once a year, 3P application source once every half month;
b) Item f) in Article 9.1 once every stroke;
c) Item d) in Article 9.1, Sr-Y application source once every two years, 32P once a day; d) When any of the items is suspected of damage or problems, it should be inspected at any time. 9.3 Inspection methods and evaluation indicators
a) Inspection of the surface integrity contamination and leakage of radioactive materials of the source window of the applicator, measure its β radioactivity according to the wiping method recommended by GB4076, and the source with a value less than 200Bg can be regarded as no leakage. b) Inspection of the radiation uniformity of the source surface of the applicator, adopt the film self-development method, use the black meter, and measure at five points, and the percentage deviation is not more than 5%. c) Determination of air absorption dose rate on the source surface of the applicator. The activity meter is used to measure the relative method, and the standard source is accurately measured by an extrapolated ionization chamber, with a total uncertainty of ±5%. Appendix A
(Normative Appendix)
Characteristics of radionuclides commonly used in patch therapy The physical properties and tissue absorption of radioactive P and Sr-Y are shown in Table A1. Table A1
Physical properties and tissue absorption of 9Sr-90Y β-ray energy
1)32p is 0.8mm.
Half-life
Average value
Maximum value
Percentage of energy absorbed in equivalent tissue at different depths as a percentage of total energy (bare source), %
B1 Preparation method
Appendix B
(Informative Appendix)
Reference method for making a simple 3P applicator
B1.1 Use high-quality filter paper (Xinhua No. 1) to cut into paper pieces of different sizes and shapes according to the shape of the lesion, as a support for the 32P solution, and draw a grid on the filter paper. B1.2 Use physiological saline to perform a water absorption test on filter papers of different sizes and shapes to determine the number of milliliters of 32P solution to be added.
B1.3 Use a hand-controlled pipette to absorb the pre-calculated 32P solution mixed with a colorant, and add 32P solution in grids according to the water absorption of each filter paper, and adjust the distribution uniformity of the 32P activity by the depth of the color. B1.4 Bake the filter paper dry and the colorant is evenly distributed. Seal it with three layers of high-quality plastic film and tape. It can be used after the surface is tested for radioactive contamination.
B2 Precautions
Before formally adding 32P, write the name of the nuclide, activity and production date on the filter paper. B2.2 Due to the siphon effect of the edge of the filter paper, the edge radioactivity increases, so a small amount of 32P solution should be added near the edge. B2.3 If the specific radioactivity of 32P is low and it cannot be added all at once, it can be dried with infrared while adding 32P solution. Appendix C
(Informative Appendix)
Shielding material β particle range
The β particle range of several materials is shown in Table C1. Table 1
β particle energy, E
β particle range of several materials
β particle range of different materials,
Tissue or water9 During the patch treatment, medical staff should take effective personal protection measures, such as wearing plexiglass glasses or masks and using remote operation tools as much as possible. 8.10 When operating the applicator, the source surface must not be facing people, and the source surface must not be looked at directly. 8.11 When using the applicator, avoid sharp objects damaging the source window surface. The applicator must not be immersed in water, alcohol or other solvents, and should be stored in a dry place after use.
8.12 The maximum allowable application area at one time should not exceed 200cm for adults and 100cm for children. It should be reduced as appropriate for infants and young children.
9 Health protection inspection for patch therapy
9.1 Acceptance inspection
Before the newly purchased or repaired applicator is officially used in clinical practice, it must be inspected by the radiation health technical service agency. The acceptance inspection items are as follows: a) Inspection of the surface integrity of the applicator source window and leakage of radioactive materials; b) Inspection of the radiation uniformity of the applicator source surface; c) Inspection of the air absorption dose rate on the applicator source surface or the air absorption dose rate at the reference point; d) Inspection of the effective activity of the applicator and the decay correction of the source surface absorption dose rate; e) Inspection of the air absorption dose rate at 5 cm and 100 cm from the surface of the source storage box; f) Inspection of the β and γ radiation levels in the patch therapy room, and the radioactive contamination of the ground and the surface of the treatment equipment; g) Inspection of the timing error of the patch therapy timer. 9.2 Regular Inspection
During clinical application, the items and cycles that should be regularly inspected are as follows: a) Items a), b), c), e) and g) in Article 9.1, 90Sr-90Y application source once a year, 3P application source once every half month;
b) Item f) in Article 9.1 once every stroke;
c) Item d) in Article 9.1, Sr-Y application source once every two years, 32P once a day; d) When any of the items is suspected of damage or problems, it should be inspected at any time. 9.3 Inspection methods and evaluation indicators
a) Inspection of the surface integrity contamination and leakage of radioactive materials of the source window of the applicator, measure its β radioactivity according to the wiping method recommended by GB4076, and the source with a value less than 200Bg can be regarded as no leakage. b) Inspection of the radiation uniformity of the source surface of the applicator, adopt the film self-development method, use the black meter, and measure at five points, and the percentage deviation is not more than 5%. c) Determination of air absorption dose rate on the source surface of the applicator. The activity meter is used to measure the relative method, and the standard source is accurately measured by an extrapolated ionization chamber, with a total uncertainty of ±5%. Appendix A
(Normative Appendix)
Characteristics of radionuclides commonly used in patch therapy The physical properties and tissue absorption of radioactive P and Sr-Y are shown in Table A1. Table A1
Physical properties and tissue absorption of 9Sr-90Y β-ray energy
1)32p is 0.8mm.
Half-life
Average value
Maximum value
Percentage of energy absorbed in equivalent tissue at different depths as a percentage of total energy (bare source), %
B1 Preparation method
Appendix B
(Informative Appendix)
Reference method for making a simple 3P applicator
B1.1 Use high-quality filter paper (Xinhua No. 1) to cut into paper pieces of different sizes and shapes according to the shape of the lesion, as a support for the 32P solution, and draw a grid on the filter paper. B1.2 Use physiological saline to perform a water absorption test on filter papers of different sizes and shapes to determine the number of milliliters of 32P solution to be added.
B1.3 Use a hand-controlled pipette to absorb the pre-calculated 32P solution mixed with a colorant, and add 32P solution in grids according to the water absorption of each filter paper, and adjust the distribution uniformity of the 32P activity by the depth of the color. B1.4 Bake the filter paper dry and the colorant is evenly distributed. Seal it with three layers of high-quality plastic film and tape. It can be used after the surface is tested for radioactive contamination.
B2 Precautions
Before formally adding 32P, write the name of the nuclide, activity and production date on the filter paper. B2.2 Due to the siphon effect of the edge of the filter paper, the edge radioactivity increases, so a small amount of 32P solution should be added near the edge. B2.3 If the specific radioactivity of 32P is low and it cannot be added all at once, it can be dried with infrared while adding 32P solution. Appendix C
(Informative Appendix)
Shielding material β particle range
The β particle range of several materials is shown in Table C1. Table 1
β particle energy, E
β particle range of several materials
β particle range of different materials,
Tissue or water9 During the patch treatment, medical staff should take effective personal protection measures, such as wearing plexiglass glasses or masks and using remote operation tools as much as possible. 8.10 When operating the applicator, the source surface must not be facing people, and the source surface must not be looked at directly. 8.11 When using the applicator, avoid sharp objects damaging the source window surface. The applicator must not be immersed in water, alcohol or other solvents, and should be stored in a dry place after use.
8.12 The maximum allowable application area at one time should not exceed 200cm for adults and 100cm for children. It should be reduced as appropriate for infants and young children.
9 Health protection inspection for patch therapy
9.1 Acceptance inspection
Before the newly purchased or repaired applicator is officially used in clinical practice, it must be inspected by the radiation health technical service agency. The acceptance inspection items are as follows: a) Inspection of the surface integrity of the applicator source window and leakage of radioactive materials; b) Inspection of the radiation uniformity of the applicator source surface; c) Inspection of the air absorption dose rate on the applicator source surface or the air absorption dose rate at the reference point; d) Inspection of the effective activity of the applicator and the decay correction of the source surface absorption dose rate; e) Inspection of the air absorption dose rate at 5 cm and 100 cm from the surface of the source storage box; f) Inspection of the β and γ radiation levels in the patch therapy room, and the radioactive contamination of the ground and the surface of the treatment equipment; g) Inspection of the timing error of the patch therapy timer. 9.2 Regular Inspection
During clinical application, the items and cycles that should be regularly inspected are as follows: a) Items a), b), c), e) and g) in Article 9.1, 90Sr-90Y application source once a year, 3P application source once every half month;
b) Item f) in Article 9.1 once every stroke;
c) Item d) in Article 9.1, Sr-Y application source once every two years, 32P once a day; d) When any of the items is suspected of damage or problems, it should be inspected at any time. 9.3 Inspection methods and evaluation indicators
a) Inspection of the surface integrity contamination and leakage of radioactive materials of the source window of the applicator, measure its β radioactivity according to the wiping method recommended by GB4076, and the source with a value less than 200Bg can be regarded as no leakage. b) Inspection of the radiation uniformity of the source surface of the applicator, adopt the film self-development method, use the black meter, and measure at five points, and the percentage deviation is not more than 5%. c) Determination of air absorption dose rate on the source surface of the applicator. The activity meter is used to measure the relative method, and the standard source is accurately measured by an extrapolated ionization chamber, with a total uncertainty of ±5%. Appendix A
(Normative Appendix)
Characteristics of radionuclides commonly used in patch therapy The physical properties and tissue absorption of radioactive P and Sr-Y are shown in Table A1. Table A1
Physical properties and tissue absorption of 9Sr-90Y β-ray energy
1)32p is 0.8mm.
Half-life
Average value
Maximum value
Percentage of energy absorbed in equivalent tissue at different depths as a percentage of total energy (bare source), %
B1 Preparation method
Appendix B
(Informative Appendix)
Reference method for making a simple 3P applicator
B1.1 Use high-quality filter paper (Xinhua No. 1) to cut into paper pieces of different sizes and shapes according to the shape of the lesion, as a support for the 32P solution, and draw a grid on the filter paper. B1.2 Use physiological saline to perform a water absorption test on filter papers of different sizes and shapes to determine the number of milliliters of 32P solution to be added.
B1.3 Use a hand-controlled pipette to absorb the pre-calculated 32P solution mixed with a colorant, and add 32P solution in grids according to the water absorption of each filter paper, and adjust the distribution uniformity of the 32P activity by the depth of the color. B1.4 Bake the filter paper dry and the colorant is evenly distributed. Seal it with three layers of high-quality plastic film and tape. It can be used after the surface is tested for radioactive contamination.
B2 Precautions
Before formally adding 32P, write the name of the nuclide, activity and production date on the filter paper. B2.2 Due to the siphon effect of the edge of the filter paper, the edge radioactivity increases, so a small amount of 32P solution should be added near the edge. B2.3 If the specific radioactivity of 32P is low and it cannot be added all at once, it can be dried with infrared while adding 32P solution. Appendix C
(Informative Appendix)
Shielding material β particle range
The β particle range of several materials is shown in Table C1. Table 1
β particle energy, E
β particle range of several materials
β particle range of different materials,
Tissue or water3 If the specific radioactivity of 32P is low and it cannot be added all at once, infrared rays can be used to dry it while adding 32P solution. Appendix C
(Informative Appendix)
Shielding material β particle range
The β particle ranges of several materials are shown in Table C1. Table 1
β particle energy, E
β particle ranges of several materialsbzxZ.net
β particle ranges of different materials,
Tissue or water3 If the specific radioactivity of 32P is low and it cannot be added all at once, infrared rays can be used to dry it while adding 32P solution. Appendix C
(Informative Appendix)
Shielding material β particle range
The β particle ranges of several materials are shown in Table C1. Table 1
β particle energy, E
β particle ranges of several materials
β particle ranges of different materials,
Tissue or water
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