This standard applies to optoelectronic X-ray image intensifiers as components of medical X-ray diagnostic equipment and describes a method for determining the size of the incident field of an X-ray image intensifier. YY/T 0457.1-2003 Characteristics of optoelectronic X-ray image intensifiers for medical electrical equipment Part 1: Determination of the size of the incident field YY/T0457.1-2003 Standard download decompression password: www.bzxz.net

YY/T 0457.12003/IEC 61262-1:1994YY/T0457 "Characteristics of optoelectronic X-ray image intensifiers for medical electrical equipment" is divided into seven parts: Part 1: Determination of human field size; Part 2: Determination of conversion coefficient; Part 3: Determination of brightness distribution and brightness non-uniformity; Part 4: Determination of image distortion; Part 5: Determination of detection quantum efficiency; Part 6: Determination of contrast and glare coefficient; Part 7: Determination of modulation transfer function. This part is the first part of YY/T0457. The consistency of this part is equivalent to IEC61262-1:1994 "Medical electrical equipment - Characteristics of photoelectric X-ray image intensifiers - Part 1: Determination of human radiation field" (English version). The main differences are as follows: some formatting formats have been modified according to Chinese habits; some expressions applicable to international standards have been changed to expressions applicable to Chinese standards; - The foreword of international standards has been deleted;
- IEC788 has been changed to IEC60788.
Appendix A and Appendix B of this part are informative appendices. This part was proposed by the State Food and Drug Administration. This part is under the jurisdiction of the National Standardization Technical Committee for Medical X-ray Equipment and Appliances. Drafting unit of this part: Liaoning Medical Device Product Quality Supervision and Inspection Institute. The main drafters of this part: Jie Yan and Mu Li. YY/T 0457.1—2003/IEC61262-1:1994 Introduction
The human field size of an optoelectronic X-ray image intensifier can be specified in several ways based on a specific source-to-surface distance (SED). Typical specifications are nominal incident field size and effective human field size. For the nominal human field size, there are an infinite number of source-to-surface distances, while the effective X-ray human field size is measured at a specific SED, usually -1 m. In this part, both the nominal human field size and the effective human field size are considered. The nominal human field size is calculated from several effective human field sizes.
This part also considers the measurement of the effective human field size of optoelectronic X-ray image intensifiers in the magnification mode. Ⅱ
1 Scope
Medical electrical equipment
YY/T0457.1--2003/IEC61262-1:1994 Characteristics of optoelectronic X-ray image intensifiers
Part 1: Determination of incident field size
This part of YY/T0457 applies to optoelectronic X-ray image intensifiers as components of medical X-ray diagnostic equipment. This part describes a method for determining the incident field size of X-ray image intensifiers. 2 Normative references
The clauses in the following documents become clauses of this part through reference in this part of YY/T0457. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to an agreement based on this part are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version of the document applies to this part.
IEC60788:1984 Medical radiology - Terminology 3 Terms
3.1 Definitions
For the purpose of this standard, the terms and definitions defined in IEC60788 and the following apply. In case of any ambiguity between the definitions, the following definitions shall prevail.
English abbreviation for electro-optical X-ray image intensifier. 3.1.2
entrance plane
The plane perpendicular to the axis of symmetry of the XRII and tangent to the most protruding part of the XRII in the direction of the radiation source (including the protective shell of the XRII).
entrance field
For XRII, the area in the entrance plane that can be used for the transmission of the X-ray pattern under specific conditions. 3.1.4
entrance field sizeFor XRII, the diameter of the area in the entrance plane that can be used for the transmission of the X-ray pattern at a specified source distance (SED). For an XRII with more than one magnification mode, the output image diameter corresponding to each magnification mode of the human field size shall be consistent with the output image diameter of the XRII at the maximum human field size. 3.1.5
source to entrance plane distance(SED)The distance between the focus of the X-ray tube and the entrance plane of the XRII. 3.1.6
centre of the output imagecentre of the output imageYY/T 0457.1---2003/IEC 61262-1 : 1994The center of the smallest circle circumscribing the output image.
centre of the entrance fieldcentre of the entrance fieldpoint on the entrance plane imaged at the center of the output image. 3.1.8
central axiscentral axis
The straight line passing through the center of the human field and perpendicular to the entrance plane. 3.1.9
Not used.
Nominal entrance field size The size of the human entrance field of an image intensifier obtained with a collimated beam of ionizing radiation from a source approaching infinity. 3.1.11
Useful entrance field size The size of the human entrance field measured on the XRII entrance plane under specified SED conditions. 3.2 Degree of requirement
Auxiliary verbs in this standard:
“shall” indicates that compliance with a requirement is necessary. “should” indicates that compliance with a requirement is strongly recommended but not mandatory. “may” indicates that compliance with a requirement is permitted in a particular way in order to comply with this standard. The following words have the following meanings:
“specific” when used with parameter or condition: refers to a particular value or standardized arrangement, usually those required by IEC standards or laws; see IEC 60788, RM-74-01. "specified" when used with parameter or condition: a value or arrangement usually indicated in the accompanying documents or selected for the purpose under consideration; see IEC60788, rm-74-02. "designed for" when used in a standard to describe the characteristics of equipment, devices, components or arrangements: indicates the intended and usually obvious application purpose or use of the product. 4 Requirements
The characteristics and settings of the measuring instruments required to measure the human field size are as follows. 4.1 Test settings
a) The SED should be 100 cm ± 1 cm.
In order to determine the nominal incident field size, additional measurements are required under conditions of SED different from 100 cm. A SED of 50 cm is recommended.
b) The focus of the X-ray tube should be on the central axis of the image intensifier. c) The X-ray field should completely cover the incident field. 4.2 X-ray image intensifier - working conditions a) The X-ray image intensifier shall be operated under the normal use conditions specified by the manufacturer; b) Not used;
c) For multi-field X-ray image intensifiers, the specified maximum human field size shall be measured, and other field sizes may be measured optionally. 4.3 Input radiation
The combination of the radiation quality used to measure the magnification and the attenuation equivalent of the test device shall give the image of the test device a high contrast. The radiation intensity shall be sufficient to obtain a low-noise image. 2
4.4 Test device
YY/T 0457.1—2003/IEC 61262-1:1994 a) The test device shall have a scale that is opaque to radiation and is of sufficient size to cover the X-ray image intensifier in normal mode. The minimum division of the scale shall not exceed 2.0 mm; b) The test device shall have two orthogonal scales to facilitate the centering of the device on the human field; c) The test device shall be placed tangential to the incident surface. 4.5 Measuring equipment
In order to center the test device in the incident field, it is recommended to use a telescope or microscope to observe the output image. In order to accurately measure the size of the human incident field, it is also recommended to use a telescope or microscope for measurement. 5 Determination of effective incident field size and nominal incident field size 5.1 Preparation
a) The test device should be placed on a plane as close to and parallel to the incident surface as possible, and should not exceed 10mm from the incident surface. b) The center of the test device should be on the central axis. c) When measuring the size of the effective human incident field, the SED should be adjusted to 100cm±1cm, see 4.1a). 5.2 Measurements
a) When illuminating the image intensifier, measure the maximum dimension of the test device used on the output image, where the SED is 100 cm ± 1 cm. To improve the accuracy of the measurement, it is recommended to use a telescope or microscope to observe the output image. In order to measure the effective human field size in the magnified mode, it is necessary to make a relative or absolute measurement of the output image diameter in the normal mode or in the non-magnified mode. The effective human field size in each magnification mode should correspond to the same output image diameter, that is, the output image diameter produced by the image intensifier in the normal mode. b) To determine the nominal human field size, set the SED to approximately 50 cm and repeat the measurements in 5.2a). 5.3 Correction
Not applicable.
5.4 Determination
The effective human field size is measured directly and does not require calculation or correction. However, the determination of the nominal human field size requires calculation based on the data measured at two different SEDs. The nominal human field size is calculated according to the following formula: d = [d, Xd × (AB) / [(AXd) - (BXd,)} In the formula:
di——-effective human field size corresponding to /2 (SED = B); d2—effective human field size corresponding to /2 (SEDA); d3—nominal human field size of the image intensifier. See Appendix B and Figure B.1 for the derived nominal human field size. 6 Description of the incident field size
The description of the incident field size should include the following information: image intensifier marking, such as type, model or number; effective human field size under each magnification mode. 3
YY/T0457.1—2003/IEC61262-1:1994 Optionally, the following can be added:
nominal human field size.
Declaration of Conformity
If it is stated that the measurement of the incident field size of the X-ray image intensifier complies with this standard, it should be expressed as: Effective human incident field size: YY/T0457.1—2003. Optionally add:
--Nominal human entrance field size: YY/T0457.1—2003.4
IEC60788
Unit name in international units
Undefined derived terms
Undefined terms
Early unit names
Abbreviations
3.1 in YY/T0457.1--2003
Accompanying documents Attenuation equivalent central axis
Centre of the entrance field ...centre of the output image Appendix A
(Informative Appendix)
Term index
YY/T 0457.1—-2003/IEC 61262-1:1994rm-..*.
rm-82-01
rm-13-37
electro-opticalX-ray imageintensifierelectro-opticalX-ray imageintensifierentrance field
entrance field sizeentrance field sizeentrance plane
focalspot
ionizing radiation
normal use
normal entrance field sizenormal focal spot valueoutput image
radiation qualityradiation source
radiation source to entrance plane distancespecific ....
specified
test devicetest device
useful entrance field sizeX-ray equipment
X-ray fieldX-ray field
Yingdiandian
X-ray image intensifierX-ray pattern
X-ray tubeX-ray tube
Photoelectric .....
rm-20-01
rm-74-01
rm-74-02
rm-71-04
rm-2 0-20
rm-37-07+
rm-32-39
rm-32-01
rm-22-03
YY/T 0457.1-2003/IEC 61262-1:1994 Appendix B
(Informative Appendix)
Derivation of nominal incident field size
Refer to Figure B.1 and then calculate the nominal human field. Incident plane
=incident plane
d—…—corresponding to the effective human field size (SED=B) when \ /2; d2
=corresponding to the effective human field size (SED-A) when π/2; d-nominal human field size of the intensifier.
Figure B.1 Geometric dimensions of the test setup
It can be seen from the figure:
(1) tan($/2)=(d2/2)/A(ds/2)/(y+A)(2) tan(Φ'/2)=(di /2)/B=(ds/2)/(y+B)In the above equation, y is:
(3) y=[(d:XA)/d2]JA
(4)-[(d,XB)/d,］-B
From equations (3) and (4), ds is obtained
(5)[(dXA)/dz］-A=[(d:XB)/d,]-B(6) d =[di Xd2 X(AB)]/[(AXdi)-(BXd2)]Here d: is the nominal human field size.1994 Optionally add:
Nominal human field size.
Conformity statement
If it is stated that the measurement of the incident field size of the X-ray image intensifier complies with this standard, it should be expressed as: Effective human field size: YY/T0457.1—2003. Optionally add:
--Nominal human entrance field size: YY/T0457.1—2003.4
IEC60788
Unit name in international units
Undefined derived terms
Undefined terms
Early unit names
Abbreviations
3.1 in YY/T0457.1--2003
Accompanying documents Attenuation equivalent central axis
Centre of the entrance field ...centre of the output image Appendix A
(Informative Appendix)
Term index
YY/T 0457.1—-2003/IEC 61262-1:1994rm-..*.
rm-82-01
rm-13-37
electro-opticalX-ray imageintensifierelectro-opticalX-ray imageintensifierentrance field
entrance field sizeentrance field sizeentrance plane
focalspot
ionizing radiation
normal use
normal entrance field sizenormal focal spot valueoutput image
radiation qualityradiation source
radiation source to entrance plane distancespecific ....
specified
test devicetest device
useful entrance field sizeX-ray equipment
X-ray fieldX-ray field
Yingdiandian
X-ray image intensifierX-ray pattern
X-ray tubeX-ray tube
Photoelectric .....
rm-20-01
rm-74-01
rm-74-02
rm-71-04
rm-2 0-20
rm-37-07+
rm-32-39
rm-32-01
rm-22-03
YY/T 0457.1-2003/IEC 61262-1:1994 Appendix B
(Informative Appendix)
Derivation of nominal incident field size
Refer to Figure B.1 and then calculate the nominal human field. Incident plane
=incident plane
d—…—corresponding to the effective human field size (SED=B) when \ /2; d2
=corresponding to the effective human field size (SED-A) when π/2; d-nominal human field size of the intensifier.
Figure B.1 Geometric dimensions of the test setup
It can be seen from the figure:
(1) tan($/2)=(d2/2)/A(ds/2)/(y+A)(2) tan(Φ'/2)=(di /2)/B=(ds/2)/(y+B)In the above equation, y is:
(3) y=[(d:XA)/d2]JA
(4)-[(d,XB)/d,］-B
From equations (3) and (4), ds is obtained
(5)[(dXA)/dz］-A=[(d:XB)/d,]-B(6) d =[di Xd2 X(AB)]/[(AXdi)-(BXd2)]Here d: is the nominal human field size.1994 Optionally add:
Nominal human field size.
Conformity statement
If it is stated that the measurement of the incident field size of the X-ray image intensifier complies with this standard, it should be expressed as: Effective human field size: YY/T0457.1—2003. Optionally add:
--Nominal human entrance field size: YY/T0457.1—2003.4
IEC60788
Unit name in international units
Undefined derived terms
Undefined terms
Early unit names
Abbreviations
3.1 in YY/T0457.1--2003
Accompanying documents Attenuation equivalent central axis
Centre of the entrance field ...centre of the output image Appendix A
(Informative Appendix)
Term index
YY/T 0457.1—-2003/IEC 61262-1:1994rm-..*.
rm-82-01
rm-13-37
electro-opticalX-ray imageintensifierelectro-opticalX-ray imageintensifierentrance field
entrance field sizeentrance field sizeentrance plane
focalspot
ionizing radiation
normal usebzxz.net
normal entrance field sizenormal focal spot valueoutput image
radiation qualityradiation source
radiation source to entrance plane distancespecific ....
specified
test devicetest device
useful entrance field sizeX-ray equipment
X-ray fieldX-ray field
Yingdiandian
X-ray image intensifierX-ray pattern
X-ray tubeX-ray tube
Photoelectric .....
rm-20-01
rm-74-01
rm-74-02
rm-71-04
rm-2 0-20
rm-37-07+
rm-32-39
rm-32-01
rm-22-03
YY/T 0457.1-2003/IEC 61262-1:1994 Appendix B
(Informative Appendix)
Derivation of nominal incident field size
Refer to Figure B.1 and then calculate the nominal human field. Incident plane
=incident plane
d—…—corresponding to the effective human field size (SED=B) when \ /2; d2
=corresponding to the effective human field size (SED-A) when π/2; d-nominal human field size of the intensifier.
Figure B.1 Geometric dimensions of the test setup
It can be seen from the figure:
(1) tan($/2)=(d2/2)/A(ds/2)/(y+A)(2) tan(Φ'/2)=(di /2)/B=(ds/2)/(y+B)In the above equation, y is:
(3) y=[(d:XA)/d2]JA
(4)-[(d,XB)/d,］-B
From equations (3) and (4), ds is obtained
(5)[(dXA)/dz］-A=[(d:XB)/d,]-B(6) d =[di Xd2 X(AB)]/[(AXdi)-(BXd2)]Here d: is the nominal human field size.
rm-20-01
rm-74-01
rm-74-02
rm-71-04
rm-20-20
rm-37-07+
rm-32-39
rm-32-01
rm-22-03
YY/T 0457.1—2003/IEC 61262-1:1994 Appendix B
(Informative Appendix)
Derivation of nominal incident field size
See Figure B.1 and then calculate the nominal human radiation field. Incident plane
=incident plane
d—…—corresponds to the effective human radiation field size (SED=B) when \ /2; d2
=corresponds to the effective human radiation field size (SED-A) when medium/2; d-nominal human radiation field size of the enhancer.
Figure B.1 Geometric dimensions of the test setup
It can be seen from the figure:
(1) tan($/2)=(d2/2)/A(ds/2)/(y+A)(2) tan(Φ'/2)=(di /2)/B=(ds/2)/(y+B)In the above equation, y is:
(3) y=[(d:XA)/d2]JA
(4)-[(d,XB)/d,］-B
From equations (3) and (4), ds is obtained
(5)[(dXA)/dz］-A=[(d:XB)/d,]-B(6) d =[di Xd2 X(AB)]/[(AXdi)-(BXd2)]Here d: is the nominal human field size.
rm-20-01
rm-74-01
rm-74-02
rm-71-04
rm-20-20
rm-37-07+
rm-32-39
rm-32-01
rm-22-03
YY/T 0457.1—2003/IEC 61262-1:1994 Appendix B
(Informative Appendix)
Derivation of nominal incident field size
See Figure B.1 and then calculate the nominal human radiation field. Incident plane
=incident plane
d—…—corresponds to the effective human radiation field size (SED=B) when \ /2; d2
=corresponds to the effective human radiation field size (SED-A) when medium/2; d-nominal human radiation field size of the enhancer.
Figure B.1 Geometric dimensions of the test setup
It can be seen from the figure:
(1) tan($/2)=(d2/2)/A(ds/2)/(y+A)(2) tan(Φ'/2)=(di /2)/B=(ds/2)/(y+B)In the above equation, y is:
(3) y=[(d:XA)/d2]JA
(4)-[(d,XB)/d,］-B
From equations (3) and (4), ds is obtained
(5)[(dXA)/dz］-A=[(d:XB)/d,]-B(6) d =[di Xd2 X(AB)]/[(AXdi)-(BXd2)]Here d: is the nominal human field size.
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