YY/T 0889-2013 English PDF (YYT0889-2013)

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YY/T 0889-2013: Intensity-modulated radiation treatment planning system - Functional performance characteristics and test methods
YY/T  0889‐2013 
YY
ICS 11.040.60
C 43
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Intensity-modulated radiation treatment
planning system — Functional performance
characteristics and test methods
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Terms and Definitions ... 5 
4  Performance Requirements ... 6 
5  Test Methods ... 6 
Annex A (Normative) Test Cases ... 9 
Annex B (Informative) Test Data ... 17 
Bibliography ... 18 
Foreword 
This Standard is drafted according to the rules specified in GB/T 1.1-2009.
Please note that some content in the Document may involve patents. The issuing
authority of this Document does not undertake the responsibility of identifying these
patents.
The Standard was proposed by State Food and Drug Administration.
The Standard shall be under the jurisdiction of National Standardization Technical
Committee of Medical Appliances Radiotherapy and Technical Committee of Nuclear
Medicine and Radiation Dosimetry Equipment (SAC/TC10/SC3).
Drafting organizations of this Standard. Beijing Institute of Medical Device Testing, Cancer
Hospital of Chinese Academy of Medical Sciences, Nuclear Science and Technology
Research Institute of Sichuan University, and Beijing Cancer Hospital.
The main drafters of this Standard. Jiao Chunying, Zhang Xin, Dai Jianrong, Li Minghui,
Gou Chengjun, and Wu Hao.
Intensity-modulated radiation treatment planning
system — Functional performance characteristics and
test methods
1  Scope 
This Standard specifies the terms, definitions, performance requirements and test
methods of intensity-modulated radiation treatment planning system.
This Standard is applicable to intensity-modulated radiation treatment planning system
with a high-energy X-beam dose calculation function (hereinafter referred to as the
System). The System is used for designing intensity-modulated radiation treatment plans
for patients.
If the system has the plan design features of radiotherapy techniques other than
intensity-modulated radiation treatment, it shall also comply with the corresponding
standards.
2  Normative references 
The articles contained in the following documents have become part of this Document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
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 15213 Medical electron accelerators - Functional performance characteristics
and test methods
GB/T 17857 Medical radiology - Terminology (Equipment for radiotherapy, nuclear
medicine and radiation dosimetry)
YY 0637 Medical electrical equipment - Requirements for the safety of radiotherapy
treatment planning systems
3.6
Organs at risk; OAR
The important normal tissues or organs. Their radiosensitivity (tolerated dose) will
significantly affect the design of therapeutic schedule or quantity of prescribed dose.
4  Performance Requirements 
4.1 Point-dose calculation accuracy
Each IMRT specified in Appendix A shall be tested.
a) For the measurement points in the target volume, deviation between dose values
calculated by system and actual measured dose shall not exceed ± 4.5%;
b) For the measurement points in OAR, deviation between dose values calculated by
system and actual measured dose shall not exceed ± 4.7%.
4.2 Dose distribution calculation accuracy
Each IMRT specified in Appendix A shall be tested.
a) Measure the dose distribution of composite field within a plane predetermined by
die body. Calculate according to the test method specified in 5.3. The points
complying with the requirements of ± 3% / 3mm shall not be less than 88% of all
points being taken into calculation;
b) Measure the dose distribution of each single field within a plane predetermined by
die body. Calculate according to the test method specified in 5.3. The points
complying with the requirements of ± 3%/3mm shall not be less than 93% of all
points being taken into calculation.
4.3 Dose target of treatment plan
For each IMRT test case specified in Appendix A, DESIGN the treatment plan in
accordance with the dose target specified in this Standard; REPORT the actual situations
that meet dose target.
Note. Dose target is expressed as certain target volume OAR or the dose radiation that can be accepted
by the organs at risk’s volume.
5  Test Methods 
5.1 Test conditions
of each test case.
c) Register and contrast the dose distribution obtained from film measurement WITH
that calculated by the system. Dose distribution obtained from the film within the
measuring plane shall be unified to a dose at certain point measured by ionization
chamber. The point shall be an appropriate point in the area of high dose and low
gradient. Assess the accuracy of the dose distribution calculation of the system,
through analyzing and measuring the percentage - the points within the plane
complying with the requirement of ± 3% / 3mm OF all points being taken into
calculation.
d) In the measured plane, the points to participate in the region of interest shall be
limited, so as to avoid including low dose region. This object can be reached in two
ways. The first is to set a dose threshold to determine the interest area; and it shall
be set to 10% of the maximum dose. The second is, if the analysis software only
supports to set rectangular interest area, the area is set as 10% of circumscribed
rectangle of isodose lines.
e) For any point within measuring area, if the deviation between measuring dose value
of such-point and calculated dose value of the system is within ±3%; or within the
dose distribution plane of system calculation AND within such circular area of which
such-point is the center of the circle, the radius is 3 mm, if there exists a point
having the same measuring dose with such-point, then such-point shall be deemed
to meet the deviation requirement of ±3%/3 mm. The percentage of points that meet
the deviation requirement of ±3%/3 mm OF all points being taken into calculation
shall meet the requirements of 4.2 a).
f) Accelerator rack shall be placed at 0°. Each single field of IMRT test cases as
specified in Appendix A shall be used for radiation. Film shall be placed at the plane
specified by each test case for the purpose of measuring the dose distribution of
each single field. The percentage of points meeting the deviation requirement of
±3%/3 mm OF all points being taken into calculation shall be analyzed according to
requirements of c)-e). It shall meet the requirements of 4.2 b).
Note. If test requirements can be fully met, other testing tools (e.g. two-dimensional array
radiation detector) may also be used for experiment to replace the film. Whether the testing tools
can fully meet the requirements of experiment, it shall be determined by all parties who reach an
agreement in accordance with the document through research and evaluation.
5.4 Dose target of treatment plan
Treatment plan shall be designed according to the requirements as stated in Appendix A.
The conformance of dose target of each IMRT test case shall be checked. Dose target of
test cas...