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YY/T 1537-2017Laser positioning system in radiation therapy—Functional-performance characteristics and test methods (English PDF)

放射治疗用激光定位系统性能和试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 2, 2017

Implementation date

April 1, 2018

Scope

YY/T 1537-2017 is the English-translated version of 放射治疗用激光定位系统性能和试验方法.

YY/T 1537-2017 is the Chinese pharmaceutical industry standard for the laser positioning system used in radiotherapy, the external lasers by which the patient is aligned to the treatment isocentre.

It specifies the functional and performance characteristics and the test methods, covering the straightness and width of the laser lines, their orthogonality and their coincidence with the isocentre, the stability of the alignment over time and after movement, and the safety of the laser sources. Issued on 2 May 2017, it has applied since 1 April 2018.

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Document preview — YY/T 1537-2017

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword4
  • 1 Scope5
  • 2 Normative references5
  • 3 Terms and definitions6
  • 4 Requirements6
  • 4.1 Accompanying documents6
  • 4.2 Coordinate system6
  • 4.3 Laser classification of laser positioning system in radiation therapy7
  • 4.4 Positioning-line width of laser positioning system in radiation therapy7
  • 4.5 Length of laser positioning-line7
  • 4.6 Straightness of laser line7
  • 4.7 Verticality of laser cross positioning-line (if applicable)7
  • 4.8 Positioning accuracy of laser positioning system in radiation therapy7
  • 4.9 Moving range of laser positioning system in mobile radiation therapy8
  • 4.10 Software functions (if applicable)8
  • 4.11 MRI compatibility (if applicable)8
  • 5 Test methods8
  • 5.1 Accompanying documents8
  • 5.2 Coordinate system8
  • 5.3 Classification of laser positioning system in radiation therapy9
  • 5.4 Positioning-line width of laser positioning system in radiation therapy9
  • 5.5 Length of laser line9
  • 5.6 Straightness of laser line9
  • 5.7 Verticality of laser cross positioning-line (if applicable)10
  • 5.8 Positioning accuracy of laser positioning system in radiation therapy10
  • 5.9 Moving range of laser positioning system in mobile radiation therapy11
  • 5.10 Positioning software of laser positioning system in radiation therapy11
  • 5.11 MRI compatibility (if applicable)11
  • Appendix A (Informative) Test phantom12

1 Scope

This Standard specifies functional-performance characteristics and test methods for laser positioning system in radiation therapy.

This Standard is applicable to the matched external laser positioning systems used in different types of radiation therapy and positioning equipment (such as cobalt-60 teletherapy machine, medical electron accelerator, radiation therapy simulator, radiation therapy CT simulator, radiation therapy MRI simulator, etc.), which are used to project a positional reference mark on the patient's skin, the patient fixing device, the stereotactic frame, and other registration devices, to position the patient during radiation therapy.

2 Normative references

The following documents are indispensable for the application of this document.

For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.

GB 7247.1-2012 Safety of laser products - Part 1. Equipment classification and requirements

GB 9706.5 Medical electrical equipment - Part 2-1. Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV

GB/T 13739-2011 Test methods for laser beam widths, divergence angle and transverse mode

GB 15213 Medical electron accelerators - Functional performance characteristics and test methods

GB/T 17857 Medical radiology - Terminology (Equipment for radiotherapy, nuclear medicine and radiation dosimetry)

4 Requirements

4.4 Positioning-line width of laser positioning system in radiation therapy At a distance of 3 m from the laser emitting window, the laser positioning-line width shall not exceed 1.0 mm.

4.3 Laser classification of laser positioning system in radiation therapy... 7

The classification of radiation therapy laser shall not be higher than the 2 M category specified in GB 7247.1-2012.

4.5 Length of laser positioning-line... 7

At a distance of 3 m from the laser emitting window, it shall not be less than 1 m.

4.6 Straightness of laser line... 7

At a distance of 3 m from the laser emitting window, within a range of not less than 1 m, the straightness shall not exceed 0.5 mm.

4.7 Verticality of laser cross positioning-line (if applicable)... 7

At a distance of 3 m from the laser emitting window, the verticality of laser projection cross positioning-line shall not be greater than 0.2 degrees.

4.8 Positioning accuracy of laser positioning system in radiation therapy

4.8.1 Consistency with reference point

The position of laser positioning-line shall be adjustable. After adjusting, the deviation between the indication position and the actual position of reference point shall not exceed ±0.5 mm.

4.8.2 Consistency with reference plane (if applicable)

The following requirements shall be met.

a) The plane formed by laser positioning-line shall be able to identify the scanning plane (such as the imaging plane of CT simulator);

b) The laser positioning system shall be adjustable. After adjusting, the laser positioning-line projected by each laser lamp shall be parallel or coincident or perpendicular to the reference plane.

4.8.3 Mobile positioning accuracy of laser positioning system in mobile

accuracy of laser positioning system in radiation therapy (if applicable)

5 Test methods

5.4 Positioning-line width of laser positioning system in radiation therapy The test method is as follows.

5.3 Classification of laser positioning system in radiation therapy... 9

TEST according to the methods given in Clause 8 and Clause 9 of GB 7247.1- 2012. It shall meet the requirements of 4.3.

a) Test environment. Ambient illumination shall be between 50 lx~500 lx. Other test environmental conditions shall meet the manufacturer's requirements;

b) Measuring plane. 3 m away from the laser emitting window;

c) Method. MEASURE according to the density distribution method given in 5.1 of GB/T 13739-2011. The measurement result shall meet the requirements of 4.4.

5.5 Length of laser line... 9

At a distance of 3 m from the laser emitting window, MAKE the laser light directly irradiated on the plane; USE a universal measuring tool to measure the line length. It shall meet the requirements of 4.5.

5.6 Straightness of laser line... 9

The test method specified in Method 1 or Method 2 can be selected for testing. Method 1.

a) USE a CCD detector to receive the positioning-line from the laser;

RECORD the position of the peak value; REPEAT sampling 10 times; and OBTAIN the average of the peak position;

b) On a precision guide rail or other equivalent devices, MOVE the detector. The moving spacing distance is 10 cm. REPEAT Step a), until the moving distance is not less than 1 m;

c) FIT the data points to obtain a straight line. The maximum deviation of each point from the straight line shall meet the requirements of 4.6.

Method 2. The coordinate paper is fixed on a vertical surface. The distance between the laser and the coordinate paper is 3 m. The laser line is projected onto the coordinate paper. Within a range of 1 m, on the coordinate paper, the degree of bending of laser line is measured. It shall meet the

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

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