Example of Product technical requirement 

Breast X -ray system

1. Product model / specification and its division description

1.1 Product model

1.2 Configuration table (see Appendix B , including a list of options and accessories)

1.3 Software information

1.3.1 Software name:

1.3.2 Software specifications and models: (if applicable)

1.3.3 Software release version:

1.3.4 Naming rules for the complete version of the software: ABCD

A : Field definition. For example: (Each field should provide specific examples).

B : (same as above);

C : (same as above requirements);

D : (same as above).

All fields and their meanings of the complete version of the software should be clarified. Three or more examples for each field are recommended.

2. Performance indicators

2.1 Working conditions

2.1.1 Environmental conditions

The working environment conditions of the product should be clarified, such as: ambient temperature, relative humidity, atmospheric pressure, etc.

2.1.2 Power supply conditions

The power supply voltage, frequency, resistance and power capacity of the product should be specified.

Shall comply with YY / T 0706-2017 of 5.2.1 requires clause.

2.2 Electric power

2.2.1 Maximum output power

The range of maximum output electric power should be specified.

Shall comply with YY / T 0706-2017 of 5.2.1 requires clause.

2.2.2 Nominal output power

The range of nominal output electric power should be specified.

Shall comply with YY / T 0706-2017 of 5.2.2 requires clause.

2.3 Load factor control and display

2.3.1 X -ray tube voltage

The X -ray tube voltage and error range supported by the system should be specified.

Shall comply with GB 9706.24-2005 of 50.103.1a requirements of clause.

If applicable, the tube voltage requirements for different collection modes should be stated, and other considerations should be similar. 

E.g.: Low-energy acquisition mode: 20 ~ 40 kV

High-energy acquisition mode: 40 ~ 60 kV

2.3.2 Current time product

The value and range of the current time product should be provided.

If the available X -ray tube current display, should be in line with GB 9706.24-2005 of 50.103.2 requirements of clause.

2.3.3 Anti-overload

The equipment shall be provided with anti-overload measures.

It shall meet the requirements of 5.3.5 of YY/T 0706-2017.

2.3.4 Focus

It shall meet the requirements of 5.3.6 of YY/T 0706-2017.

2.3.5 Target surface material

It shall meet the requirements of 5.3.7 of YY/T 0706-2017.

2.3.6 Additional filtration

Shall comply with YY / T 0706-2017 of 5.3.8 requires clause.

2.4 Imaging performance

2.4.1 Automatic exposure control (AEC) system

Shall comply with YY / T 0706-2017 of 5.4.1 requires clause.

2.4.2 Artifacts

Shall comply with YY / T 0706-2017 of 5.4.2 requires clause.

2.4.3 Afterimage

Shall comply with YY / T 0706-2017 of 5.4.3 requires clause.

2.4.4 Anti-scatter grid

Shall comply with YY / T 0706-2017 of 5.4.4 requires clause.

2.4.5 Spatial resolution

Shall comply with YY / T 0706-2017 of 5.4.5 requires clause.

2.4.6 Low contrast resolution

It shall meet the requirements of 5.4.6 of YY/T 0706-2017 .

2.4.7 Average breast dose

Shall comply with YY / T 0706-2017 of 5.4.7 requires clause.

2.4.8 Uniformity of digital image receiver

Shall comply with YY / T 0706-2017 of 5.4.8 requires clause.

2.4.9 The material attenuation rate between the upper surface of the breast support plate and the plane of the image receptor

The specified value and range of the material attenuation rate between the upper surface of the breast support plate and the plane of the image receptor should be specified.

2.4.10 The imaging performance of the mammary gland tomosynthesis photography mode

2.4.10.1 AEC system: repeatability

Typical acquisition conditions should be specified.

Tested under typical acquisition conditions, the test results meet the declared value range.

Shall comply with IEC61233-3-6 the 9.2.1 clause requirements.

2.4.10.2 AEC performance

Typical acquisition conditions should be specified.

Tested under typical acquisition conditions, the test results meet the declared value range.

Shall comply with IEC61233-3-6 the 9.4.1 clause requirements.

2.4.10.3 Image Receiver: Response Function

Typical acquisition conditions should be specified.

Tested under typical acquisition conditions, the test results meet the declared value range.

Shall comply with IEC61233-3-6 of 10.1.2 requirements of clause.

2.4.10.4 Image receiver: defective detector

Typical acquisition conditions should be specified.

The type and number range of the detector's dead pixels should be specified.

Tested under typical acquisition conditions, the test results meet the declared value requirements.

Shall comply with IEC61233-3-6 of 10.2.1 requirements of clause.

2.4.10.5 Image receiver: uncorrected dead pixels

Typical acquisition conditions should be specified.

It should be stipulated that the captured image has no dead pixels.

Tested under typical acquisition conditions, the test results meet the declared value requirements.

Shall comply with IEC61233-3-6 of 10.3.2 requirements of clause.

2.4.10.6 Projected image MTF

Typical acquisition conditions should be specified.

The range of modulation transfer function ( MTF ) should be specified

Tested under typical acquisition conditions, the test results meet the declared value requirements.

Shall comply with IEC61233-3-6 of 10.4.2 requirements of clause.

2.4.10.7 ACR phantom test

Typical acquisition conditions should be specified.

Using ACR phantom, according to the typical acquisition conditions tested, should be consistent with IEC61233-3-6 of 11.1.2 required terms.

2.4.10.8 Z axis resolution

Typical acquisition conditions should be specified.

According to the typical acquisition conditions, it should meet the requirements of 11.2.1 of IEC61233-3-6.

2.4.10.9 The tissue on the breast wall side of the reconstructed image is lost

Typical acquisition conditions should be specified.

The requirements regarding image quality should be specified.

Tested under typical acquisition conditions, the test results meet the declared value requirements.

Shall comply with IEC61233-3-6 of 12.2.1 requirements of clause.

2.4.10.10 The organization of the top and bottom layers of the reconstructed image is lost

Typical acquisition conditions should be specified.

The requirements regarding image quality should be specified.

Tested under typical acquisition conditions, the test results meet the declared value requirements.

Shall comply with IEC61233-3-6 of 12.3.1 requirements of clause.

2.4.10.11 Artifacts of volume data

Typical acquisition conditions should be specified.

Requirements regarding artifacts should be specified.

Tested under typical acquisition conditions, the test results meet the declared value requirements.

Shall comply with IEC61233-3-6 of 13.2.1 requirements of clause.

2.4.10.12 Geometric distortion

Typical acquisition conditions should be specified.

According to the typical acquisition conditions, the test results should meet the declared value range.

Shall comply with IEC61233-3-6 of 13.3.1 requirements of clause.

2.4.10.13 Dose of breast tomographic photography

Typical acquisition conditions should be specified.

The requirements for the average gland dose index should be specified.

Tested under typical acquisition conditions, the test results meet the declared value requirements.

Shall comply with IEC61233-3-6 of 14.1 required provisions.

2.4.10.14 Imaging angle range

The scope of rotation of the cast hood frame should be specified.

Test according to the acquisition conditions, and the test results meet the declared value and error range.

2.5 Mechanical device performance

2.5.1 Mechanical movement

2.5.1.1 The vertical travel range and error of the projection frame should be specified.

2.5.1.2 The rotation angle range and error of the projection frame shall be specified.

2.5.1.3 It should be specified that the projection frame can be locked at any position in the full stroke.

2.5.1.4 The focal point - image receiving surface ( FID ) distance and error shall be specified .

2.5.1.5 The motion state of the mechanical device should be specified when the power supply is interrupted.

2.5.1.6 According to the change of the acquisition mode, if other mechanical devices move, the result should also meet the declared value and error range.

2.5.2 Compression device

It shall meet the requirements of Clause 5.5.2 of YY/T 0706-2017.

The results of other parameters should meet the declared value and error range.

2.5.3 Compression plate

Should meet the relevant requirements of GB 9706.24-2005.

If special reconstruction or image processing technology is used, a compression plate is required for imaging, and the specific requirements of the compression plate should be stated.

2.5.4 Braking force

It shall meet the requirements of Clause 5.5.4 of YY/T 0706-2017.

2.5.5 Length indication value

The deviation between the indicated value of the length and the actual value shall be specified.

2.5.6 Angle indication value

The deviation of the angle indication value and the actual deviation value should be specified.

2.5.7 Noise

It shall meet the requirements of Clause 5.5.9 of YY/T 0706-2017.

2.5.8 Protective shielding

The requirements for protective shielding shall be specified.

2.6 Software function

2.6.1 Network communication

The function of network communication should be specified.

2.6.2 Information Management

The functions of information management should be specified.

For basic software functions such as patient management, patient registration, shooting and reconstruction, 2D image browsing and processing, 3D image browsing and processing, and film printing, the applicant should specify at least a description of the menu functions.

2.6.3 Other software application functions

For other application functions, a software function outline (if applicable) should be specified.

2.7 Acquisition mode

The typical image acquisition mode of the product should be listed, for example:

1 ) Two-dimensional X -ray photography of breast (for example: FFDM mode);

2 ) Three-dimensional tomography of the breast (for example: tomography mode, combined imaging mode, two-dimensional composite image mode).

2.8 Cybersecurity

2.8.1 Data interface

The standard that the data interface should comply with and the type of communication protocol used should be specified.

2.8.2 User Access Control

2.8.2.1 Local user access control

The types and conditions of local user access control should be specified.

2.8.2.2 Remote user access control

The types and conditions of remote user access control should be specified.

Necessary explanations (if any) should be made regarding restrictions.

2.9 High-voltage cable plugs and sockets

It shall meet the requirements of YY/T1541 on type and basic dimensions, markings and connections. If there are other requirements, specific requirements should be stated.

2.10 Appearance

Should meet the requirements of YY/T 0706-2017 Clause 5.8.

2.11 Foot switch

Should meet the requirements of YY 1057-2016.

2.12 Stereotaxic

2.12.1 Stereotactic performance (including different modes) 

2.12.2 Needle guide

1 ) Appearance

2 ) Mechanical properties

3 ) Sterile

If applicable, it should be sterile.

2.12.3 Adapter

2.12.3.1 Appearance

1 ) The surface coating and electroplating should be free of scratches, and there should be no defects that may affect the appearance, fit or function.

2 ) The connectors should be matched and tightened without looseness.

3 ) The slider should be flexible and not locked.

2.12.3.2 Assembling the puncture needle / revolving needle

The adapter locks the pin holder, and the pin should remain fixed in all directions.

Unlock the adapter and remove the needle. The needle should remain in the adapter or be released from the adapter.

2.12.3.3 Rotation

The direction and range of rotation of the adapter when the needle is left in the adapter.

2.12.3.4 ejection

The needle is placed in the adapter, and the adapter should be able to eject the needle upwards.

2.13 Energy spectrum imaging

Through the energy spectrum imaging function, low-energy and high-energy images are collected, and the reconstructed energy spectrum image should not produce artifacts.

2.14 Environmental test

Should meet the requirements of YY/T 0291-2016. The climatic environmental conditions are group I, and the mechanical environmental conditions are group I (if applicable).

2.15.1 Electrical safety

It shall meet the requirements of GB 9706.1, GB 9706.11, GB 9706.12, GB 9706.14, GB 9706.1 and GB 9706.24 . See Appendix A for product safety features.

2.15.2 Electromagnetic compatibility

Should meet the requirements of YY 0505-2012.

3. Method

3.1 Working conditions

Should meet the requirements of 2.1.

3.2 Electric power

3.2.1 Maximum output power

Press YY / T 0706-2017 the 6.2.1 test method provisions.

3.2.2 Nominal electric power

Press YY / T 0706-2017 the 6.2.2 test method provisions.

3.3 Load factor control and display

3.3.1 X -ray tube voltage

Press YY / T 0706-2017 the 6.3.1 test method provisions.

3.3.2 Current time product

Press the 0706-2017 YY / T of 6.3.4 test method provisions.

3.3.3 Anti-overload

Press the 0706-2017 YY / T of 6.3.5 test method provisions.

3.3.4 Focus

Press the 0706-2017 YY / T of 6.3.6 test method provisions.

3.3.5 Target surface material

Press the 0706-2017 YY / T of 6.3.7 test method provisions.

3.3.6 Additional filtration

Press YY / T 0706-2017 the 6.3.8 test method provisions.

3.4 Imaging performance

3.4.1 Automatic exposure control (AEC) system

Press YY / T 0706-2017 the 6.4.1 test method provisions.

3.4.2 Artifacts

Press YY / T 0706-2017 the 6.4.2 test method provisions.

3.4.3 Afterimage

Press the 0706-2017 YY / T of 6.4.3 test method provisions.

3.4.4 Anti-scatter grid

Press the 0706-2017 YY / T of 6.4.4 test method provisions.

3.4.5 Spatial resolution

Press the 0706-2017 YY / T of 6.4.5 test method provisions.

3.4.6 Low contrast resolution

Press the 0706-2017 YY / T of 6.4.6 test method provisions.

3.4.7 Average breast dose

Press the 0706-2017 YY / T of 6.4.7 test method provisions.

3.4.8 Digital image uniformity

Press YY / T 0706-2017 the 6.4.8 test method provisions.

        3.4.9 The attenuation rate of the material between the upper surface of the breast support plate and the plane of the image receptor

According to GB / T 19042.2-2005 the 5.8.2 test method provisions.

3.4.10 System performance of mammary gland tomosynthesis photography mode

3.4.10.1 AEC system repeatability

Typical acquisition conditions should be specified. According to IEC61233-3-6 the 9.2.2 test method provisions.

3.4.10.2 AEC performance

Typical acquisition conditions should be specified. According to IEC61233-3-6 the 9.4.2 test method provisions.

3.4.10.3 Image Receiver: Response Function

Typical acquisition conditions should be specified. Carry out the test according to the method of 10.1.3 of IEC61233-3-6.

3.4.10.4 Image receiver: defective detector

Typical acquisition conditions should be specified. Carry out the test according to the method of 10.2.2 of IEC61233-3-6.

3.4.10.5 Image receiver: uncorrected dead pixels

Typical acquisition conditions should be specified. Carry out the test according to the method of 10.3.3 of IEC61233-3-6.

3.4.10.6 Projected image MTF

Typical acquisition conditions should be specified. Carry out the test according to the method of 10.4.3 of IEC61233-3-6 .

3.4.10.7 Phantom test

Typical acquisition conditions should be specified. Carry out the test according to the method of 11.1.3 of IEC61233-3-6.

3.4.10.8 Z axis resolution

Typical acquisition conditions should be specified. Carry out the test according to the method of 11.2.2 of IEC61233-3-6.

3.4.10.9 Loss of tissue on the chest wall side of the reconstructed image

Typical acquisition conditions should be specified. According to IEC61233-3-6 of 12.2.2 test method provisions.

3.4.10.10 The organization of the top and bottom layers of the reconstructed image is lost

Typical acquisition conditions should be specified. According to IEC61233-3-6 of 12.3.2 test method provisions.

3.4.10.11 Artifacts in tomographic volume data

Typical acquisition conditions should be specified. Carry out the test in accordance with 13.2.2 of IEC61233-3-6.

3.4.10.12 Geometric distortion

Typical acquisition conditions should be specified. Carry out the test according to the method of 13.3.2 of IEC61233-3-6 .

3.4.10.13 Dose of breast tomographic photography

Typical acquisition conditions should be specified. According to IEC61233-3-6 of 14.2 test method provisions.

3.4.10.14 Acquisition angle range

Methods that have been methodologically validated should be used for inspection.

3.5 Mechanical device performance

3.5.1 Mechanical movement

3.5.1.1 The vertical travel range of the projection frame

Use length measuring tool to measure.

3.5.1.2 The rotation angle range of the projection frame

Use angle measuring tools to measure.

3.5.1.3 The projection frame should be locked at any position in the full stroke.

Press YY / T 0706-2017 of 6.5.1.3 test method.

3.5.14 Focus - distance of image receiving surface ( FID )

Use length measuring tool to measure.

3.5.1.5 When the power supply is interrupted, the movement state of the mechanical device

Press YY / T 0706-2017 of 6.5.1.5 test method.

3.5.1.6 Carry out the inspection according to the method provided by the applicant.

3.5.2 Compression device

Use a dynamometer to measure.

3.5.3 Compression plate

Actual operation check.

3.5.4 Braking force

Use a dynamometer to measure.

3.5.5 Length indication value

Use length measuring tool to measure.

3.5.6 Angle indication value

Use angle measuring tools to measure.

3.5.7 Noise

The test shall be carried out in accordance with the method in YY/T 0706-2017 clause 6.5.9.

3.5.8 Protective shielding

The equivalent equivalent of the protective shielding shall be tested in accordance with the method in Clause 6.4 of YY 0292.1-1997.

3.6 Software function

3.6.1 Network communication

Check the standard declaration that the product complies with.

3.6.2 Information Management

Actual operation check.

3.6.3 Other software application functions

Actual operation check.

3.7 Acquisition mode

Actual exposure operation, observe the image display.

3.8 Cybersecurity

3.8.1 Data interface

Actual operation check.

3.8.2 User access control

1 ) Local user access control

Actual operation check.

2 ) Remote user access control

Actual operation check.

3.9 High-voltage cable plugs and sockets

Test according to the method of YY/T 1541.

3.10 Appearance

Visual inspection.

3.11 Foot switch

Press YY 1057-2016 testing requirements.

3.12 Stereotaxic

3.12.1 Stereotactic performance (including different modes)

2D stereo positioning: select appropriate exposure conditions for FFDM photography, and use an angle measuring tool to measure the angle of the position, which should meet the requirements of 2.12.1.

3D stereo positioning: select appropriate exposure conditions for Tomo photography, use an angle measuring tool to measure the angle of the position, which should meet the requirements of 2.12.1.

3.12.2 Needle guide

1 ) Appearance

Actual operation check.

2 ) Mechanical properties

Actual operation check.

3 ) Sterile

It should be sterile.

3.12.3 Adapter

3.12.3.1 Appearance

Actual operation check.

3.12.3.2 Assembling the puncture needle / revolving needle

Actual operation check.

3.12.3.3 Rotation

Actual operation check.

3.12.3.4 ejection

Actual operation check.

3.13 Energy spectrum imaging

Use a textured test phantom to obtain an energy spectrum image. Viewing the low-energy image and the subtracted image, there should be no related visible artifacts, and the subtracted image should have no visible texture.

3.14 Environmental test

Carry out the test according to the method specified in YY/T 0291-2016.

3.15 Product safety

3.15.1 Electrical safety

It should be tested according to the methods of GB 9706.1, GB 9706.11 , GB 9706.12 , GB 9706.14 , GB 9706.15 , and GB 9706.24 .

3.15.2 Electromagnetic compatibility

Test according to the method of YY 0505-2012.

4. Terminology

5. Appendix

Appendix A. Product safety features

Appendix B. Product Configuration Table

Appendix C. Calculation of average mammary gland dose

Appendix D. Test Phantom

Appendix E. Compatible Needle Biopsy Instruments