GB 16362-2010Requirements for quality assurance and radiological protection for patients in teletherapy (English PDF)

Foreword

4,5,6 this standard are mandatory, the rest are recommended. Rules of the draft standard is based on the preparation of GB/T 1.1-2009 "Standardization Guide Part 1. Standard structure and write." This standard replaces GB 16362-1996 "external beam radiation therapy in patients with radiation health protection standards." This standard compared with GB 16362-1996, the main changes are as follows:

--- Teletherapy unit will be renamed using the unit to carry out long-range radiation therapy unit (hereinafter referred to as radiotherapy units), amended on Its requirements, the introduction of the "Radiation treatment regulations," and supporting standards in terms of radiation conditions on the unit personnel, equipment and Claim;

--- Modify the general requirements for teletherapy patient protection, the introduction of the relevant provisions of GB Z179-2006;

--- Will merge the relevant provisions require radiation therapy equipment, radiation therapy and operating requirements for radiation dose measurement requirements for Quality assurance requirements;

--- Increased requirements on the quality of radiotherapy simulators and other auxiliary equipment control;

--- Increased the radiation treatment planning system quality control requirements;

--- Added Appendix A, Appendix B. This standard is proposed and administered by the People's Republic of China Ministry of Health. This standard by the People's Republic of China Ministry of Health is responsible for interpretation. This standard was drafted. Shandong Academy of Medical Sciences Institute of Radiation Medicine. The main drafters of this standard. Song Gang, Lu Feng, Deng Daping, Zhu Jianguo, Chen Yingmin, Li Hailiang, Cheng Yufeng, LIU Li-ping. This standard replaces the standards previously issued as follows:

--- GB 16362-1996. Teletherapy radiological protection and quality assurance requirements of patients

1 Scope

GB 16362 covers external beam radiotherapy - the linear accelerators, the medical gamma units, the X-knife and the gamma-knife that deliver a prescribed dose to a tumour from outside the body, where the margin between an effective treatment and an injury is narrow and the errors are systematic rather than random. Clause 4 fixes the conditions the radiotherapy unit must satisfy before it treats anyone: a protection and quality control organisation headed by the director of radiation oncology, verified dosimetry instruments, a justification assessment made by an oncologist holding at least an intermediate qualification, written information to the patient on the risk, and working interlocks with anti-crushing protection on the door. Clause 5 follows the patient through treatment - the plan countersigned by an oncologist and a medical physicist, the estimate of the dose to organs outside the target, the caution required for children and pregnant women, the immobilisation during X-knife and gamma-knife irradiation, and what is to be recorded when a source fails to return to its shielded position. Clause 6 is the quality assurance programme: validated planning software, acceptance testing after installation and after a key repair, an annual status test, stability testing against the acceptance baselines, the daily-weekly-monthly-annual schedule of checks, and participation in the TLD postal dose comparison. Issued on 14 January 2011, in force since 1 May 2011, replacing GB 16362-1996. This page is published from the official record of the standard and from its published table of contents. The full clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

This standard specifies the teletherapy in patients with quality assurance and protection of basic principles and requirements. This standard applies to the medical electron accelerators and medical gamma-ray devices for external beam therapy and X, gamma-ray stereotactic put Radiation therapy (hereinafter referred to as X knife, gamma knife) and other teletherapy Practice, practice does not apply to the treatment of deep X-ray therapy machine.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 17856 radiotherapy simulator performance and test methods

GB 18871 ionizing radiation protection and safety of radiation sources basic standards

GB/T 19046 Medical Electron Accelerator acceptance tests and periodic inspection procedures GB Z126 Medical Electron Accelerator health protection standards GB Z161 Medical gamma beam teletherapy protection and safety standards GB Z168 X, gamma-ray head of stereotactic surgical treatment of radiation protection standards GB Z179 basic requirements for medical exposure Radiological Protection GB Z/T 201.1 radiotherapy treatment rooms - Part

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Teletherapy teletherapy Between the radiation source to skin distance is greater than 50cm in vitro radiation beam radiation therapy.

3.2 Teletherapy quality assurance qualityassuranceinteletherapy Implementation teletherapy, in order to ensure the accuracy of the location and geometry of the target dose of irradiation to reduce the radiation dose to normal tissues and organs, Exposed personnel to prevent a series of measures taken by mistake irradiation formed.

4 Basic Principles

4.1 units to carry out long-range radiation therapy (hereinafter referred to as radiotherapy units) shall comply with national regulations and relevant radiation treatment radiation Other personnel and equipment conditions and requirements supporting standard treatment prescribed.

4.2 Radiotherapy Unit shall establish radiological protection and quality control management organizations, radiation oncologists, medical physicists and radiotherapy technicians and other personnel Medical technicians to implement protection and quality control measures in their work, and to assume corresponding responsibilities.

4.3 radiotherapy units should be in accordance with GB 18871 and GB Z179 requirements, develop system of protection of patients and radiotherapy quality assurance program, and Staff engaged in teletherapy protection of patients undergoing regular training and quality control to ensure that from the management system and quality control procedures Radiation therapy is implemented correctly.

4.4 radiotherapy units should be equipped with appropriate protection of patients and quality control testing equipment, and in accordance with the provisions of verification or calibration on a regular basis, get together Grid certificate. After detection equipment within the validity period after major repairs may involve measurement scale, should be re-verification or calibration.

4.5 for patients with prior radiation therapy, radiation oncologists should be more than mid-level professional and technical qualifications by-Example legitimacy sentence Off. Only when the advantages outweigh the disadvantages, the order for radiation therapy, and should take the largest relative benefits of treatment options, and each case treated Process data archiving. Radiation oncologist before radiation therapy should be informed in writing of the possible risks of patients or their families.

4.6 Radiation therapy should be strictly controlled indications, benign try not to use radiation therapy, radiation therapy to strictly control sensitive benign disease Disease in vitro radiotherapy.

4.7 radiotherapy apparatus (including radiation therapy simulation and other auxiliary equipment), places and the environment should be consistent with GB 18871, GB Z126, GB Z161, GB Z168, GB Z/T 201.1 and other relevant radiological protection standards, should ensure that the interlock system to work properly, the door should have anti-extrusion protection And forced manual measures.

4.8 radiotherapy unit to deal with possible implementation of radiotherapy failure or mistakes, development of contingency plans, and training and emergency drills.

5 Patient protection requirements

General requirements

5.1 teletherapy patient protection should comply with the relevant provisions of GB Z179. It should develop detailed radiotherapy treatment planning based on clinical findings

5.2 before radiation therapy, including the type of radiation therapy, the target tissue dose fractionated Cloth, split mode, the treatment cycle. For radiation treatment planning of orders to be checked, signature recognition and archiving. Intermediate professional treatment plan should be And technical qualifications more radiation oncologists and medical physicists who co-signed.

5.3 developing radiation therapy plans for addressing the absorbed dose outside the target vital organs were estimated by lesions, including the use of Organ shield, including appropriate technologies and measures to protect the normal tissues and organs, to ensure treatment requirements under the premise that it is reasonable to It reached the lowest possible level.

5.4 Unless there are good reasons and obvious on clinical indications, pregnant or may become pregnant women and children should be careful using radiation therapy. in Radiation therapy for pregnant women should be carried out to implement any more careful treatment planning, so that the embryo or fetus suffered radiation dose is minimized.

5.5 In the course of treatment, patients should be regularly checked and analyzed to adjust the treatment plan as required changes in condition, pay close attention to in vitro Radiotherapy radiation damage effects that appear with possible radiation injury, to take the necessary measures for the protection of health.

5.6 therapeutic radiographers precautions should be receiving radiation therapy when inform patients, including radiotherapy when holding position, breathing regulator, How does the body appears timely schematic staff and so on.

5.7 first radiotherapy, competent radiation oncologists should guide therapeutic radiographers correct positioning, the implementation of the treatment plan.

5.8 during irradiation in particular X knife, gamma knife precision radiotherapy process should take measures to maintain the patient's position unchanged for pediatric patients can Appropriate use of sedatives or anesthetics. Irradiation process should be closely observed in patients, and found that postural change or other circumstances, should promptly stop photo Radio, and record the time and dose has been irradiated after treatment ended, for continued treatment should be re-positioning, the planned dose.

5.9 irradiation process, equipment operation should be closely observed, abnormal, should immediately stop the irradiation, detailed records and to identify the causes and timely Correction, before the completion of correction should not treat patients.

5.10 after completion of radiation therapy, if found radioactive source teletherapy gamma-ray apparatus unreturned storage position, shall promptly patient from treatment Indoor transferred out, therapeutic radiographers should be a detailed record of irradiated patients after completion of the normal residence time in the room and location information such as estimated Operators excessive radiation doses in patients keep detailed records.

5.11 radiotherapy apparatus self-protection performance should meet GB Z126, GB Z161, GB Z168 to be self-protection device performance begging. Safety performance radiotherapy apparatus should be ordering, installation and commissioning, acceptance testing, periodic testing, routine maintenance and corrective maintenance to be Guarantee.

6 Quality assurance requirements

6.1 Radiotherapy Unit Radiological Protection and Quality Control management organizations should have a clear job responsibilities, the person in charge of the general director of Radiation Oncology, Persons, including radiation oncologists, medical physicist, radiation therapy technicians and nurses. Radiological Protection and Quality Control Manager

6.2 The organization shall establish a complete quality control and organize the implementation procedures, including radiation therapy device Quality (radioactive sources or radiation devices), analog positioning device, radiation treatment planning system, such as radiotherapy dosimeter control.

6.3 system design software program for radiotherapy should be validated and access to national drug regulatory authorities officially licensed original product. User software should be factory-trained and fully master the use of the software. After the software is upgraded before use should be re-verified.

6.4 radiotherapy apparatus (including radiotherapy simulator equipment and other auxiliary equipment) quality control tests include the following three categories.

6.4.1 radiotherapy apparatus detecting means after a new installation or repair of key components, the replacement should have the appropriate qualifications for acceptance Testing.

6.4.2 radiotherapy apparatus detecting mechanism in normal operation should be carried out once a year by a qualified status detection. Detection check Test personnel and Pijiandanwei medical physicist or radiation protection management personnel should also be present and sign it. State detection and record format Content may refer to Appendix A.

6.4.3 Radiotherapy Radiotherapy Unit in accordance with relevant quality control testing specifications or standards for radiation treatment device periodically stable Detection, corresponding baseline values and test results obtained with the acceptance testing of comparison, if the two deviations exceed the permitted levels should identify the cause and Promptly corrected, stability testing results should be fully documented and archived.

6.5 radiotherapy apparatus quality control testing should be in accordance with GB/T 17856, GB/T 19046, GB Z126, GB Z161 with GB Z168, etc. Carry out the standard provisions. Quality

6.6 radiotherapy devices and radiation treatment planning system control test items based on the detection period can be divided into daily inspection, weekly inspection, monthly inspection And inspection programs, details of which are related to radiotherapy quality control testing specifications or standards.

6.7 radiotherapy apparatus, analog positioning device and radiation treatment planning system found unstable or quality control testing indicators in use When not meet the standards and regulatory requirements, should stop using, in order to carry out the work after passing through the detection and repair.

6.8 clinical data of various doses of radiotherapy units used, for example, the total treatment time, planning target volume description, percentage depth dose, etc. Data, wedge factor, by qualified medical personnel physical collection, recording, and after the person in charge can be applied to clinical governance review Therapy. Clinical data should be regularly re-examination, general inspection once a year, a key component of the equipment maintenance, replacement, also need to re-examination, such as parameters Non-compliance, should be re-acquisition.

6.9 The total distance of the uncertainty of radiation therapy targeting should conform to appropriate standards. The overall uncertainty of factors affect the allocation shown Example See Appendix B.

6.10 radiotherapy units should actively participate in national, international or regional TLD postal dose ratio of activities.

Appendix A

(Informative) Format and content of state inspection records Format and content of state inspection records radiotherapy apparatus shown in Table A.1. Table A.1 state inspection records table Device Name. Model. Manufacturer. Serial number. Detecting environmental conditions. temperature °C% relative humidity air pressure hPa Testing equipment. testing equipment verification/calibration date and validity. testing base. Test items value of the reference Detection conclusions and recommendations. A medical physicist (Signature). Radiological Protection Management (signature). year month day Radiological Protection and Quality Control Leader (Signature). year month day

Appendix B

(Informative) The overall uncertainty of the location and target dose factors allocation map Each impact B.1 remote radiotherapy target geometry factor allocation Figure B.1. Figure B.1 geometry factors of deviation requirements Each physical impact B.2 remote radiotherapy dose distribution factors shown in Figure B.2. Uncertainty physical dose distribution in Figure B.2 Factors Affecting