How long will the true-PDF of English version of WS 667-2019 be delivered?

Upon your order, we will start to translate WS 667-2019_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Can I share the purchased PDF of WS 667-2019_English with my colleagues?

Yes. The purchased PDF of WS 667-2019_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Does the price include tax/VAT?

Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries). Avoidance of Double Taxation Agreements (DTAs) between Singapore and 100+ Countries: https://www.iras.gov.sg/taxes/international-tax

Do you accept my currency other than USD?

Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Path: Home > MISC > Page350 > WS 667-2019 || Home > Standard_List > MISC > Page350 > WS 667-2019

WS 667-2019 PDF English

Price & Delivery

US$499.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
WS 667-2019: Specification for testing of quality control in robotic arm radiotherapy device
Status: Valid

Std ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status
WS 667-2019	English	499	Add to Cart	4 days [Need to translate]	Specification for testing of quality control in robotic arm radiotherapy device	Valid

Standard similar to WS 667-2019

GBZ 130 | GBZ/T 250 | GBZ/T 201.1 | WS/T 675 | WS 674 | WS/T 668 |

Basic data

Standard ID	WS 667-2019 (WS667-2019)
Description (Translated English)	Specification for testing of quality control in robotic arm radiotherapy device
Sector / Industry	Health Industry Standard
Classification of Chinese Standard	C57
Word Count Estimation	20,27
Date of Issue	2019-09-27
Date of Implementation	2020-04-01
Regulation (derived from)	National Health Communication (2019) No. 11
Issuing agency(ies)	National Health Commission

WS 667-2019: Specification for testing of quality control in robotic arm radiotherapy device

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Specification for testing of quality control in robotic arm radiotherapy device ICS 13.280 C 57 WS People's Republic of China Health Industry Standard Specification for quality control testing of robotic arm radiation therapy equipment 2019-09-27 posted 2020-04-01 implementation Published by the National Health Committee of the People's Republic of China

Foreword ... II 1 Scope ... 1 2 Terms and definitions ... 1 3 General requirements ... 2 4 Dose interlocking and indication performance test methods ... 2 5 Detection methods ... 3 Appendix A (Normative Appendix) Testing Items, Testing Conditions and Requirements ... 9 Appendix B (informative) Test reference phantom selected ... 11 Appendix C (informative) Calculation formula for laterally charged particle equilibrium distance ... 15 References ... 17

Foreword

Chapter 3 and Appendix A of this standard are mandatory, and the rest are recommended. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was drafted. Institute of Radiation Medicine, Shandong Academy of Medical Sciences, Peking University Cancer Hospital, Beijing Center for Disease Control and Prevention heart. The main drafters of this standard. Deng Daping, Lu Feng, Wu Hao, Ma Yongzhong, and Li Hailiang. Specification for quality control testing of robotic arm radiation therapy equipment

1 Scope

This standard specifies the quality control and protective performance testing items, testing methods and requirements of robotic arm radiation therapy devices. This standard applies to quality control and protective performance testing of robotic arm radiation therapy devices.

2 terms and definitions

The following terms and definitions apply to this document. 2.1 Robotic arm radiotherapy device A radiotherapy device for concentrating multiple high-energy X-ray beams to a target area by a robotic arm for treating lesions in various parts of the human body. Note. The device contains three main components. a linear accelerator, a robotic arm, and an X-ray imaging system. 2.2 End-to-End (E2E) test By using the phantom to simulate the clinical radiotherapy process, from scanning the phantom to formulating the radiotherapy plan (starting end) to completing the irradiation (ending end), A quality control test for the positioning and tracking accuracy of a robotic arm radiation therapy device. Note. The purpose is to determine the overall position deviation of each tracking mode of the robotic radiation therapy device. 2.3 Ball cube One of the quality control testing phantoms of a robotic arm radiation therapy device, used to measure positioning and tracking accuracy. Is a square phantom containing A film of acrylic spheres was placed, which in the measurement represented the illuminated target area. 2.4 Dose output stability The dose output by the robotic radiotherapy device maintains stable performance relative to the baseline value in the initial state. 2.5 Tracking method Robotic arm radiation therapy device automatically corrects real-time images of exposure acquisition of the X-ray imaging system by moving the position of the robotic arm or treatment table Image and treatment planning method of computer tomography (CT) scan-generated digitally reconstructed image (DRR) deviation in the six-dimensional direction of space. Note. Tracking methods generally include six-dimensional skull tracking methods, gold label tracking methods, spine tracking methods, synchronized breathing tracking methods, and lung tracking methods.

3 General requirements

3.1 The quality control and protective performance testing items, testing conditions and requirements of the robotic arm radiation therapy device are shown in Appendix A. 3.2 After new installation or overhaul of the robotic arm radiation therapy device, acceptance inspection should be carried out, and condition inspection and stability inspection should be performed regularly during use. Measurement. The testing items of acceptance testing and status testing shall cover the items specified in this standard. The corresponding test items of the tested equipment shall be explained in the test report. 3.3 The contents of the report of the acceptance test and status test shall include at least. the basic information of the inspected unit, the basic information of the inspected equipment, the test items, Test conditions, test results and test conclusions. 3.4 The results of the acceptance test and status test are qualified when they meet or exceed the corresponding requirements in Appendix A. 3.5 The stability testing items shall include at least the items specified in Appendix A, and the frequency of testing shall not be less than the period specified in Appendix A. Make The unit shall record and archive the corresponding information such as the date of the stability test, the test personnel, and the test results.

4 Functional test method for dose interlock and indication

4.1 Number and function of dose monitoring systems 4.1.1 Place the robotic arm radiation therapy device during the irradiation process, observe whether the console interface has a dual-channel dose monitoring system and display positive often. 4.1.2 Test the two dose monitoring systems separately. After one dose monitoring system is artificially closed, observe whether the other one works normally The output dose is displayed and the irradiation can be stopped immediately. 4.2 Low dose rate interlocking 4.2.1 In physical mode, preset the robot arm radiation therapy device to output 1000 MU. 4.2.2 Observe whether the dose can be terminated immediately when the dose rate is artificially lower than 85% of the normal dose rate. 4.3 Treatment bed collision indication 4.3.1 Use a phantom to create a treatment plan for the head or body; in demo mode, this plan is allowed to be executed. 4.3.2 Close the door-machine interlock to enter the treatment room; use the hand control box to raise the treatment bed or move it to the left and right for a certain distance (for example 15 cm). 4.3.3 In demo mode, execute the created treatment plan; observe if the execution can be terminated at a location that may cause a collision Make a treatment plan and give a collision warning message. 4.4 Fixed collimator picking error indication 4.4.1 In the treatment room, manually change the placement of any fixed collimator. 4.4.2 On the console, drive the robotic arm to pick up the collimator whose placement has been changed, and observe if a fixed collimator pick-up appears on the console Get the error message. 4.5 Console display, password protection and interlock 4.5.1 Observe whether the console interface can display the irradiation dose and irradiation time parameters. 4.5.2 Using the phantom, create a treatment plan for the head or body, and observe whether the treatment plan output is password protected. 4.5.3 In the physical mode, the artificial default console irradiation parameter pre-selected value, observe whether the irradiation can be started; when the key switch is not turned on, Observe whether the irradiation can be started.

5 Detection methods

5.1 Dose output stability deviation 5.1.1 Place the equivalent plate phantom or other equivalent phantom of the robotic arm radiation therapy device on the treatment table, and use the front pointer to determine the phantom And then insert it into the ionization chamber. 5.1.2 Connect the electrometer to the ionization chamber and preheat it. 5.1.3 Preheat the accelerator. 5.1.4 After the warm-up is complete, use a 60 mm collimator to obtain an electrometer reading at.200 MU three times. 5.1.5 Take the average of the three electrometer readings, and use the temperature and pressure correction to obtain the dose output value. 5.1.6 Compare the dose output value with the baseline value (usually obtained from the initial performance test) and calculate the dose output stability according to formula (1) Deviation S.    DDS BA ... (1) In the formula. S-deviation of dose output stability,%; AD-Absorbed dose output value in gray (Gy); BD-baseline value of absorbed dose in grays (Gy). 5.2 Imaging system positioning deviation 5.2.1 Place an isocenter column (a cylinder with a diameter of about 4.5 cm and a height of about 92 cm) for the robotic radiation therapy device, with an equal center at the top (Cardiac point) to the image detector bracket. 5.2.2 In the Treatment Planning System (TPS), create a treatment plan. X-ray imaging systems set appropriate exposure conditions (such as 60 kV, 50 mA), expose and acquire an isocenter cue point image. 5.2.3 Use the zoom tool to enlarge the image to clearly observe the crosshairs at the center of the image and take a snapshot of the image. 5.2.4 Measure and record the deviation between the position of the isocenter and the baseline position. 5.3 Treatment table position deviation 5.3.1 Place the treatment bed in the home position. 5.3.2 Use a digital angle measuring instrument to measure the horizontal angle deviation in the X-axis (left-right) and Y-axis (front-back) directions of the treatment table. 5.3.3 When the treatment bed is in the home position, make a mark on the base of the treatment bed, and at the same time on the corresponding position on the removable cover Make a mark. 5.3.4 Use the hand control box to translate the treatment bed by 5.0 cm and press the home button until the treatment bed stops moving. Measure the mark on the base of the treatment table Note the deviation from the mark on the removable cover. 5.4 Target Tracking System Tracking Deviation 5.4.1 Obtain a CT scan image of the special phantom (head and neck phantom) (scan layer thickness is not greater than 1.25 mm) and import it into TPS. See Appendix B for the material, structure, and shape of the head and neck phantoms. 5.4.2 In TPS, create a treatment plan and save it as an executable plan to generate a DRR. 5.4.3 Place the phantom on the treatment table. In phantom mode, you go to the treatment execution interface through a series of user interface windows. Reset Position the phantom so that the deviation of the treatment bed is close to zero. 5.4.4 Use the treatment table movement function of the treatment execution interface to translate or rotate the phantom into multiple different positions and record the actual value of the movement. 5.4.5 Expose the X-ray imaging system at each position, compare the acquired real-time image with DRR, and record the target location System displacement estimates (ie correction values for the treatment table displayed on the treatment execution interface). 5.4.6 Compare the correction value of the treatment table with the actual value of the movement using the automatic bed function, and record the deviation. 5.5 Automatic Quality Assurance (AQA) Bias 5.5.1 Obtain a CT scan image of the special phantom (AQA phantom) for automatic quality assurance (the thickness of the scan layer is not greater than 1.25 mm), and guide Into TPS. See Appendix B for the material, structure, and appearance of the AQA phantom. 5.5.2 In TPS, outline the spherical target area in the mold body, use the gold label tracking method to develop an AQA test plan and save it. 5.5.3 Load no-rinsing film into the mold and place it at the center of the imaging system on the treatment table. 5.5.4 Execute the saved AQA test plan. 5.5.5 Remove the film from the phantom and mark the direction. 5.5.6 Scan the film and import the image into the film analysis software; by analyzing the kiss between the center of the circular dose area on the film and the center of the ball in the phantom The degree of integration gives the AQA deviation. 5.6 End-to-end (E2E) deviation of the static tracking method 5.6.1 Obtain a CT scan image of the special phantom (head and neck phantom) with a sphere (the thickness of the scan layer is not greater than 1.25 mm), and Import TPS. See Appendix B for the material, structure and shape of the sphere. 5.6.2 In TPS, outline the relevant treatment volume in the phantom, using the six-dimensional skull tracking method, gold label tracking method, and spinal tracking Trace method to develop and save E2E test plan. 5.6.3 Fill the mold with no-rinsing film and place on the treatment table. 5.6.4 Execute the saved E2E test plan. 5.6.5 Remove the film from the phantom and mark the direction. 5.6.6 Scan the film and import the image into the film analysis software; by analyzing the coincidence between the center of the isodose curve on the film and the center of the spherical phantom The degree of E2E deviation of the three static tracking methods. 5.7 End-to-end (E2E) deviation of the synchronized breathing tracking method 5.7.1 Obtain a CT scan image of the special phantom (dome phantom) with a sphere (the thickness of the scan layer is not greater than 1.25 mm) and import it into TPS. See Appendix B for the material, structure, and appearance of the dome phantom. 5.7.2 In TPS, use the synchronized breathing tracking method to develop an E2E test plan and get the dose in each direction through the center of the target area Distribution. 5.7.3 Fill the mold with no-rinsing film and place it on the treatment bed. 5.7.4 Execute the saved E2E test plan without movement. 5.7.5 Use a 5 cm thick styrofoam pad under the phantom and place it on the synchronized breathing movement tracking tool; Large forward and backward movements use at least two LED tracking marks. 5.7.6 In the case of synchronous breathing movement tracking tool movement (phase shift does not exceed 10 °, speed is between 15 r/min and 16 r/min) Perform an E2E test plan. 5.7.7 Remove the film from the phantom and mark the direction. 5.7.8 Scan the film and import the image into the film analysis software; overlap the static and dynamic test dose distribution maps, Combined to obtain the E2E deviation of the synchronized breathing tracking method. 5.8 End-to-end (E2E) bias of the lung tracking method 5.8.1 Obtain a CT scan image of the special phantom (chest phantom) (the thickness of the scan layer is not greater than 1.25 mm) and import it into TPS. chest See Appendix B for the material, structure, and shape of the phantom. 5.8.2 In TPS, use the lung tracking method to develop an E2E test plan and save it. 5.8.3 Install the non-rinsing film into the ball side, and place the ball side in the cavity of the moving rod. Insert one end of the moving rod into the chest phantom and the other One end is connected to the motion controller. 5.8.4 After placing the phantom on the treatment bed, first use the spine tracking method to adjust the phantom, and then use the lung tracking method to adjust the target area. Then use the synchronous tracking method to track the target area during the treatment. 5.8.5 After execution of the treatment plan, remove the film from the phantom and mark the direction. 5.8.6 Scan the film and import the image into the film analysis software; overlap the static and dynamic test dose distribution maps, Combined to obtain the E2E bias of the lung tracking method. 5.9 Deviation of planned dose from measured dose 5.9.1 Obtain a CT scan image of a marker-dosing phantom or other equivalent phantom inserted into the ionization chamber (scan layer thickness No more than 1.25 mm) and import TPS. The distance between the boundary of the effective collection volume of the ionization chamber detector and the boundary of the measured irradiation field should be Meet the distance requirements for laterally charged particle balance. See Appendix C for the formula for calculating the equilibrium distance of laterally charged particles. 5.9.2 In TPS, use the gold standard tracking method to develop an E2E test plan for the 60 mm collimator and save it. Read ionization from TPS The chamber measures the planned dose at the reference point. 5.9.3 Transfer the phantom to the treatment table and execute the radiation treatment plan. The actual absorbed dose was measured using a dosimeter. 5.9.4 Calculate the deviation 1vD between the planned dose and the measured dose according to formula (2).   Pl Pl1 1  D DDD av ... (2) In the formula. 1vD-the relative deviation between the planned dose and the measured dose,%; 1aD-actual measurement of absorbed dose in Gy; 1PD-Radiation therapy plan dose value in Gy. 5.10 Deviation of absorbed dose 5.10.1 Place a water tank or other equivalent phantom on the ground. Adjust to keep it level. 5.10.2 Move the robot arm so that the central axis of the radiation beam is perpendicular to the horizontal plane. 5.10.3 Using the front pointer, adjust the distance from the accelerator target to the detector to 80 cm. 5.10.4 After the accelerator is warmed up, irradiate.200 MU and measure the absorber at the depth of 10 cm on the central axis of the radiation beam of the 60 mm collimator And absorbed dose at the maximum dose point depth (typically 1.5 cm). 5.10.5 Calculate the tissue phantom ratio 10TPR at a depth of 10 cm according to formula (3). max 10  D DTPR ... (3) In the formula. 10TPR-Tissue phantom ratio at a depth of 10 cm,%; 10D-absorbed dose at a depth of 10 cm, in Gy; maxD-Absorbed dose at maximum dose point depth in Gy. 5.10.6 Compare the measured TPR10 with the nominal TPR10 in TPS to calculate the deviation in the absorbed dose. 5.11 Indication deviation of dose monitoring system 5.11.1 Place a water tank or other equivalent phantom on the ground. Adjust to keep it level. 5.11.2 Move the robot arm so that the central axis of the radiation beam is perpendicular to the horizontal plane. Place the effective measurement point of the ionization chamber horizontally on the central axis of the radiation beam 5.0 cm below. Using the front pointer, adjust the distance from the accelerator target to the horizontal plane to 75 cm. 5.11.3 Connect the dosimeter to the ionization chamber and preheat it. 5.11.4 Preheat the accelerator. 5.11.5 After the warm-up is complete, use a 60 mm collimator to obtain the dosimeter readings at three outputs of.200 MU. 5.11.6 Take the average of the three dosimeter readings and use the temperature, pressure, TPR and other factors to obtain the absorbent at the calibrated depth. the amount. 5.11.7 Compare the absorbed dose at the calibration depth with the value indicated by the dose monitoring system and calculate the deviation according to formula (4).   2   pa v D DD D ... (4) In the formula. 2vD-deviation of the indicated value of the dose monitoring system,%; 2aD-average value of absorbed dose measurements at calibrated depth in Gy; 2pD-The indicated value of the dose monitoring system in Gy. 5.12 Irradiation field size deviation 5.12.1 Place the solid water phantom on the ground. Adjust to keep it level. 5.12.2 Move the mechanical arm so that the central axis of the radiation beam is perpendicular to the surface of the solid water phantom. 5.12.3 Place a non-rinsing film 5.0 cm below the surface of solid water. Using the front pointer, adjust the distance from the accelerator target to the non-rinsing film 80 cm. 5.12.4 After the accelerator is warmed up, use collimators with different nominal sizes for irradiation. Exposure dose can keep film exposure dose Measure the best linear range of the grayscale curve. 5.12.5 Take out the film and mark the direction of the irradiation field. Scan the film with a film scanner and save the image. 5.12.6 Use the film analysis software to open the image and find the axis (X-axis, Y-axis) passing through the center of the irradiation field on the film and 50% equivalent Measure the intersection point of the curve, measure the distance between the two intersection points, compare it with the corresponding size in the TPS database, and calculate the photo according to formula (5) Shooting field size deviation vsS. pavs SSS  ... (5) In the formula. vsS-the deviation of the irradiation field size in millimeters (mm) aS-the distance between the intersection of the axis (X-axis, Y-axis) of the center of the irradiation field and the 50% isodose curve on the film analysis software Distance in millimeters (mm); pS --The corresponding dimensions given in TPS, in millimeters (mm). 5.13 Illumination field penumbra width 5.13.1 Same as 5.12.1 ～ 5.12.3. 5.13.2 After the accelerator is warmed up, use a 40 mm collimator for irradiation. Exposure dose keeps film exposure dose at dose gray Within the best linear region of the curve. 5.13.3 Take out the film and mark the direction of the irradiation field. Scan the film with a film scanner and save the image. 5.13.4 Use the film analysis software to open the image and find out the axes (X-axis, Y-axis) passing through the center of the irradiation field on the film and 80% Intersection of isodose curve, 20% isodose curve. Measure the distance between two intersections. 5.14 Leak emissivity through the collimator 5.14.1 Same as 5.10.1 ～ 5.10.3. 5.14.2 After the accelerator is warmed up, irradiate 1000 MU, and measure the position of the solid collimator and the 60 mm collimator on the central axis of the radiation beam. Absorbed dose at a depth of 1.5 cm. When measuring a variable collimator, the collimator should be completely closed and placed at a distance of about 1 cm away from the central axis of the radiation beam Take measurements. 5.14.3 Calculate the leakage radiation rate through the collimator according to formula (6). 0R  open close coll D ... (6) In the formula. collR-leakage radiation rate through the collimator,%; closeD-solid collimator (or close collimator), absorbed dose at a depth of 1.5 cm, in Gy; openD --60 mm collimator (fixed collimator or variable collimator), absorbed dose at 1.5 cm depth in Gy. AA

Appendix A

(Normative appendix) Testing items, testing conditions and requirements See Table A.1 for quality control and protective performance testing items, testing conditions and requirements of the robotic arm radiation therapy device. Table A.1 Quality control and protective performance testing items, testing conditions and requirements Terms testing items Acceptance test State test Stability test Test conditions require test conditions 5.1 Dose output stability deviation 60 mm Collimator establishes baseline value-- 60 mm collimation ± 2% of baseline value Within a day 5.2 Imaging system positioning deviation-within ± 1.0 mm-within ± 1.0 mm-within ± 1.0 mm for one month 5.3 Treatment bed position deviation- Angle deviation ± 0.3 ° Within Translation deviation ± 1.0 within mm Angle deviation ± 0.3 ° Within Translation deviation ± 1.0 within mm Angular deviation Within ± 0.3 °; Translation deviation ± 1.0 within mm A month 5.4 Tracking deviation of target positioning system-within ± 2.0 mm-within ± 2.0 mm-within ± 2.0 mm for three months 5.5 Automatic quality assurance (AQA) deviation a Automatic quality assurance phantom ≤ 1.0 mm-- Automatic quality assurance Card phantom ≤ 1.0 mm a day 5.6 End-to-end (E2E) for static tracking methods Deviation a Head and neck Motif ≤0.95 mm--Head and neck phantom ≤0.95 mm per month 5.7 End-to-end synchronous breath tracking method (E2E) Deviation a Dome Phantom ≤1.5 mm--Dome phantom ≤1.5 mm per month 5.8 End-to-end (E2E) lung tracking methods Deviation a chest phantom ≤1.5 mm--Chest phantom ≤1.5 mm per month 5.9 Deviation of planned dose from measured dose a 60 mm collimator 60 mm collimator within ± 5% 60 mm collimator within ± 5% Within ± 5% a month 5.10 Depth of Absorbed Dose a 60 mm Collimator 60 mm collimator within ± 3% 60 mm collimator within ± 3% Within 6 months within ± 3% 5.11 Indication deviation of dose monitoring system a 60 mm collimator Within ± 3% 60 mm collimator Within ± 3%--- 5.12 Irradiation field size a 5.13 Radiation field penumbra width a 40 mm collimator ≤4.5 mm 40 mm collimator≤4.5 mm 40 mm collimator ≤4.5 mm per month 5.14 Leakage radiation rate through the collimator a-≤1.0%----- a Robotic arm radiation therapy device equipped with fixed collimator and variable collimator. The fixed collimator and variable collimator should be tested separately. The functional test items and requirements of the dose interlocking and indication of the robotic radiation therapy device are shown in Table A.2. Table A.2 Functional test items and requirements for dose interlocking and indication of robotic arm radiation therapy devices Article test items require acceptance testing status testing stability testing cycle 4.1 Number of Dose Monitoring Systems There is a dual-channel dose monitoring system. √-- 4.1 Function of the dose monitoring system Any one of these dose monitoring ...

WS 667-2019 PDF English

Price & Delivery

Standard similar to WS 667-2019

Basic data

WS 667-2019: Specification for testing of quality control in robotic arm radiotherapy device

Contents

Foreword

1 Scope

2 terms and definitions

3 General requirements

4 Functional test method for dose interlock and indication

5 Detection methods

Appendix A

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of WS 667-2019_English be delivered?

Question 2: Can I share the purchased PDF of WS 667-2019_English with my colleagues?

Question 3: Does the price include tax/VAT?

Question 4: Do you accept my currency other than USD?