YY/T 0310-2015 (YY/T0310-2015, YYT 0310-2015, YYT0310-2015)
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General specifications for X-ray equipment for computed tomography
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YY/T 0310-2015
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Standards related to: YY/T 0310-2015
| Standard ID | YY/T 0310-2015 (YY/T0310-2015) | | Description (Translated English) | General specifications for X-ray equipment for computed tomography | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 13,170 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Older Standard (superseded by this standard) | YY 0310-2005 | | Quoted Standard | GB 9706.1; GB 9706.11; GB 9706.12; GB 9706.14; GB 9706.15; GB 9706.18; GB/T 10149; GB/T 10151; GB/T 19042.5-2006; YY 0076-1992; YY/T 0291; YY 0505; YY 0637; YY/T 0708 | | Drafting Organization | Liaoning Province Medical Device Testing | | Administrative Organization | National Medical Electrical Standardization Technical Committee medical X-ray equipment and utensils Standardization Sub-Technical Committee | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This Standard specifies the X-ray computed tomography apparatus (hereinafter referred to as CT scanning device) terms and definitions, classification, composition, requirements and test methods. This Standard applies to CT scanning device, including the provision of image data into radiotherapy planning CT scanning device. | YY/T 0310-2015
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
Replacing YY 0310-2005
General specifications for X-ray equipment for
computer tomography
ISSUED ON. MARCH 2, 2015
IMPLEMENTED ON. JANUARY 1, 2016
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Classification and composition ... 5
5 Requirements ... 6
6 Test methods ... 13
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY 0310-2005 General specifications for X-ray
equipment for computed tomography.
Compared with YY 0310-2005, the main technical changes are as follows.
- Modified the description of application scope, including CT scanner which
provides image data for radiation treatment planning;
- Added YY 0505 and YY/T 0708 as normative references;
- Modified environmental conditions in requirements to conditions required
by GB 9706.1;
- Added requirements for scanning frame rotation speed;
- Modified the original scanning time to exposure time;
- Deleted indicating instrument (5.5.5 of 2005 edition);
- Added requirements and test methods of radiation treatment planning
(RTP).
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of Sub-committee on Medical X-
ray Equipment and Utensils of National Technical Committee on Medical
Appliances of Standardization Administration of China (SAC/TC 10/SC 1).
Drafting organizations of this Standard. Liaoning Provincial Medical Device
Testing Institute, and GE Healthcare.
Main drafters of this Standard. Wang Jianjun, Hao Suli, Mou Li, Han Qiang, and
Wang Shoumin.
This Standard replaces the following previous standards.
- YY 0310-1998, YY 0310-2005.
General specifications for X-ray equipment for
computer tomography
1 Scope
This Standard specifies the terms and definitions, classification, composition,
requirements and test methods of X-ray equipment for computed tomography
(hereinafter referred to as CT scanner).
This Standard is applicable to CT scanner, including CT scanner which provides
image data for radiation treatment planning.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for
safety
GB 9706.11 Medical electrical equipment - Part 2. Particular requirements
for the safety of X-ray source assemblies and X-ray tube assemblies for
medical diagnosis
GB 9706.12 Medical electrical equipment - Part 1. General requirements
for safety 3.collateral STANDARD. General requirements for radiation
protection in diagnostic X-ray equipment
GB 9706.14 Medical electrical equipment - Part 2. Particular requirements
for the safety of associated equipment of X-ray equipment
GB 9706.15 Medical electrical equipment - Part 1. General requirements
for safety - 1. Collateral standard. Safety requirements for medical electrical
systems
GB 9706.18 Medical electrical equipment - Part 2. Particular requirements
for the safety of X-ray equipment for computed tomography
GB/T 10149 Terminology and symbol for medical X-ray equipment
GB/T 10151 Medical diagnostic X-ray equipment - Specifications for high
voltage cable plugs and sockets
GB/T 19042.5-2006 Evaluation and routine testing in medical imaging
departments - Part 3-5. Acceptance tests-Imaging performances of
computed tomography X-ray equipment
YY 0076-1992 Coating classifications for metal product - Technical
conditions
YY/T 0291 Environmental requirements and test methods for medical x-ray
equipment
YY 0505 Medical electrical equipment Part 1-2. General requirements for
safety Collateral standards. Electromagnetic compatibility Requirements and
tests
YY 0637 Medical electrical equipment - Requirements for the safety of
radiotherapy treatment planning systems
YY/T 0708 Medical electrical equipment - Part 1-4.General requirements
for safety - collateral standard. programmable electrical medical systems
3 Terms and definitions
Terms and definitions defined in GB/T 10149, GB 9706.18, GB/T 19042.5-2006
and YY 0637 apply to this document.
4 Classification and composition
4.1 Classification
Security classification shall comply with the requirements on classification in
GB 9706.1.
4.2 Composition
CT scanner shall be composed of the following parts.
a) Scanning frame;
b) X-ray generator;
c) Patient support;
d) Console;
M1, M2 - Marks on patient support surface;
d1, d2 - Distance between marking point and Z-axis.
Figure 2 Positioning at Z-axis of patient support on level plane
5.7.2 Patient support surface
Patient support surface shall be plane, or the attachment which can make it as
plane shall be indicated in accompanying file and make it obtained.
Positioning aids of therapy system are allowed to use by patient support.
5.7.3 Diagnostic bed sag (patient support rigidity)
It shall stipulate the diagnostic bed sag within 40 cm (typical scan length plus
the amount of movement of scanning plane).
5.7.4 Integrated positioning light used for patient positioning
If positioning light is integrated in CT scanner, accompanying file shall verify if
the intended use of positioning light can be used for patient positioning in RTP.
If the intended use of positioning light can be used for patient positioning in RTP,
it shall have the following accuracy.
The accuracy of axial positioning light at isocenter shall be ± 1 mm. The
accuracy at ± 250 mm in X direction shall be ± 2 mm.
Sagittal and coronal positioning lights shall be extended to within scanning
plane. The accuracy related to rotation axis shall be ± 1 mm.
Marking line width of positioning light at isocenter (FWHM) shall not exceed 1
mm.
5.7.5 Typical scanning mode that generates RTP
The accompanying file shall stipulate the typical CT operating conditions which
generate images for RTP. The agreement not applicable to generate RTP image
shall be indicated in the accompanying file.
For RTP’s typical CT operating conditions, the accompanying file shall provide
measurement results of noise, average CT value and uniformity measured by
the methods in GB/T 19042.5-2006.
5.7.6 HU value conversion
HU value of each model measured under CT operating conditions indicated in
5.7.5, and the conversion of electronic and mass density values related to
a) CT scanner appearance shall look neat, beautiful; the surface shall be
smooth and clean; the color shall be even; there must no damage spots,
cracks and other defects;
b) The main electroplating pieces of CT scanner shall comply with
requirements on grade 2 appearance in YY 0076-1992.
5.9 Environment test
It shall comply with requirements of YY/T 0291. The final test items shall at least
contain 5.2.1, 5.2.2, 5.2.3, 5.2.5, 5.2.8 and 5.5.3.
5.10 Safety
It shall comply with requirements of GB 9706.1, GB 9706.11, GB 9706.12, GB
9706.14, GB 9706.15, GB 9706.18, YY 0505 and YY/T 0708.
6 Test methods
6.1 Test conditions
CT scanner shall be tested under the following conditions.
a) Unless otherwise specified, all performance tests shall be conducted
under conditions stipulated in 5.1;
b) CT body model which complies with American Association of Physicists
in Medicine (AAPM) standard is recommended;
c) Unless otherwise specified, it shall use CT conditions of typical head and
body to scan.
6.2 Performance
6.2.1 Image noise
Under typical head scanning conditions (recommended to use 10 mm slice
thickness), use head CTDI body model to measure center dose.
If the equipment does not have 10 mm slice thickness, the product standard
shall stipulate the conversion factor of image noise.
Place the homogeneous medium body model (20 cm water model) within scan
field of view. Make body model axis coincide with the rotation axis of scanning
frame. After scanning, select a region of interest of which the diameter is about
40% of image diameter. Measure the standard deviation SD of CT value in this
region. Use formula (1) to calculate noise value N.
reconstruct. Adjust the window width and window level. Observe the image
through monitor. Take the diameter of the distinguishable minimum hole group
as reference.
6.2.6 Operating noise
In the fastest scan state, use sound level meter to respectively measure the
operating noise at 1.5 m height from ground, 1 m from the front, back, left and
right of scanning frame surface. Take the maximum.
6.2.7 Artifact
Place water model within scan field of view. Make body model axis coincide
with the rotation axis of scanning frame. Select a group of CT operating
conditions to scan. Observe water model’s CT image when window level is 0,
window width are respectively 50 HU, 100 HU.
6.2.8 Slice thickness
This Standard recommends the following method.
Place measurement sli...
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