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HJ 1198-2021: Requirements of radiation safety and protection for radiotherapy
HJ 1198-2021
HJ
ECOLOGICAL ENVIRONMENT STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Requirements of radiation safety and protection for
radiotherapy
ISSUED ON: OCTOBER 17, 2021
IMPLEMENTED ON: DECEMBER 01, 2021
Issued by: Ministry of Ecology and Environment
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 General requirements ... 5
5 Site selection, layout, zoning requirements ... 6
6 Radiation safety and protection requirements for radiotherapy sites ... 7
7 Operational radiation safety and protection requirements ... 10
8 Radioactive waste management requirements ... 11
9 Radiation monitoring requirements ... 13
Appendix A (Normative) Residence factors in different places ... 15
Appendix B (Normative) Activity and activity concentration of radioactive waste
exemption ... 16
Requirements of radiation safety and protection for
radiotherapy
1 Scope
This standard specifies the radiation safety and protection requirements for medical
institutions to carry out radiotherapy.
This standard applies to radiation safety and protection management of radiation
workers and the public, in radiation therapy-related activities in medical institutions.
This standard does not apply to radionuclide therapy, patch therapy, radioactive seed
implantation therapy, boron neutron capture therapy, radiotherapy simulation diagnosis.
The production, commissioning, repair and maintenance activities and scientific
research activities of radiotherapy equipment can be carried out, with reference to this
standard.
2 Normative references
This standard refers to the following documents or their clauses. For dated references,
only the dated version applies to this standard. For undated references, the latest edition
(including all amendments) applies to this standard.
GB 18871-2002 Basic standards for protection against ionizing radiation and for the
safety of radiation sources
"Radioactive waste classification" (Announcement of Ministry of Environmental
Protection, No.65 of 2017)
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
Radiation worker
Those who are or may be exposed to ionizing radiation, in medical institutions,
engaged in radiation therapy-related activities, including physicians, medical
physicists, technicians and nurses, as well as formal staff, temporary staff and interns,
such as radiation therapy equipment installation and commissioning engineers,
maintenance engineers, radiation protection managers, etc.
3.2
Survey system
A system, through which the radiation workers use reset buttons and other methods
to clear and inspect the areas accessible to personnel in the accelerator hall or
treatment room according to a certain line sequence, meanwhile verify personnel
retained or other abnormal situations, before the beams of large accelerator devices,
such as proton/heavy ion accelerators, are released. It is generally set up in areas
related to large accelerators, such as proton/heavy ion accelerators.
4 General requirements
4.1 Medical institutions, that are engaged in radiotherapy, shall be fully responsible for
the radiation safety and protection of radiotherapy activities; achieve the goal of
protecting radiation workers engaged in radiotherapy, public health and environmental
safety.
4.2 Medical institutions engaged in radiation therapy shall establish a sound radiation
safety and protection management system; formulate a radiation safety and protection
program; implement management systems such as job responsibilities and operating
procedures.
4.3 In the process of planning, designing, constructing radiotherapy workplaces and
carrying out radiotherapy activities, medical institutions engaged in radiotherapy shall
follow the justification of practice, optimization of safety and protection, dose
limitation and potential exposure risk limitation, to ensure that radiation doses exposed
by the radiation workers and the public involved in the treatment are at a safe and
reasonable level.
4.4 Medical institutions engaged in radiotherapy shall set up appropriate multi-layer
protection and safety measures, according to the potential exposure hazard level of
radiotherapy activities and the principle of defense in depth, so as to ensure that when
a certain level of defense measures fails, the defensive measures of the next level are
used for remedy or correction, so as to:
a) Prevent accidents that may cause false exposure;
b) Mitigate the radiological consequences of accidents;
c) Restore radiotherapy equipment to a safe state.
4.5 The items constituting the safety interlocking system of radiotherapy-related
radiation workplaces shall meet the following requirements:
a) It shall meet the redundancy requirements; the items used shall be the minimum
number of items necessary to complete a certain safety function, so as to ensure
that the whole function will not be lost, when an item fails or does not work during
operation;
b) It shall meet the diversity requirements, including system diversity and multiple
dose monitoring, using different operating principles, different physical variables,
different operating conditions, different components, etc.;
c) It shall meet the independence requirements. When a certain safety component
fails, it will not cause the failure or loss of function of other safety components;
d) It shall meet the requirements of failure safety. When a certain safety item or
component fails, it shall ensure that the radiotherapy device returns to a safe state.
4.6 Medical institutions engaged in radiotherapy shall standardize the collection, proper
temporary storage, disposal of radioactive waste, which is generated in radiotherapy
activities.
4.7 Medical institutions engaged in radiotherapy shall conduct regular radiation
monitoring and evaluation of the radiotherapy site and surrounding environment, to
prove the effectiveness of the radiation safety and protection measures taken.
4.8 The radiation exposure of radiation workers and members of the public shall comply
with the relevant requirements on dose limits in GB 18871-2002.
4.9 The dose constraint values for occupational exposure of staff engaged in
radiotherapy and public exposure shall meet the following requirements:
a) In general, the dose constraint value for occupational exposure of workers
engaged in radiotherapy is 5 mSv/a.
b) The dose constraint value for public exposure shall not exceed 0.1 mSv/a.
4.10 Medical institutions carrying out radiotherapy activities shall formulate
corresponding emergency plans for radiation accidents; do a good job in emergency
preparations, emergency drills, emergency responses for radiation accidents, to ensure
effective prevention of radiation accidents or mitigation of the consequences of
radiation accidents.
5 Site selection, layout, zoning requirements
5.1 Site selection and layout
5.1.1 The site selection of radiotherapy sites shall fully consider its radiation impact on
structural performance and protective performance; meet the optimization requirements.
Neutron shielding must be considered, when using neutron source radiotherapy
equipment, proton/heavy ion accelerators or X-ray radiotherapy equipment greater than
10 MV.
6.1.3 When the pipeline passes through the shielding object, the method that does not
affect its shielding effect shall be adopted, meanwhile sh...