1 Scope
This standard specifies the definitions, requirements, test methods, and inspection rules for B-mode ultrasonic diagnostic equipment (hereinafter abbreviated “B-mode ultrasound”).
This standard is applicable to B-mode ultrasonic diagnostic equipment with a nominal frequency range of 1.5 MHz - 15 MHz and includes the two-dimensional greyscale imaging part of color Doppler ultrasonic diagnostic equipment (color ultrasound).
This standard is not applicable to ultrasonic diagnostic equipment used in ophthalmology or to intravascular ultrasonic diagnostic equipment.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding amending error in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of the normative document is applicable. For undated references, the latest edition of the normative document applies.
GB 9706.1 Medical electrical equipment--Part 1:General requirements for safety(GB 9706.1—2007, idt IEC 60601-1：1988)
GB 9706.9 Medical electrical equipment-Parts 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment(GB 9706.9—2008, idt IEC 60601-2-37：2001)
GB 9706.15 Medical electrical equipment-Part 1-1: General requirements for safety-Collateral standard: Safety requirements for medical electrical systems(GB 9706.15—2008, idt IEC 60601-1-1：2000)
GB/T 14710 The environmental requirements and test methods for medical electrical equipment
YY/T O108—2008 M-mode test methods for ultrasonic diagnostic equipment
YY/T 1142—2003 Methods of measuring frequency characteristics of ultrasonic diagnostic and monitoring equipment
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Axial resolution
At a specified depth of a phantom, the minimum distance between two targets that can be displayed as two echo signals along the ultrasound beam axis.
Unit: mm.
3.2
Lateral resolution
At a specified depth of a phantom, perpendicular to the ultrasonic beam in the scan plane, the minimum distance between two target lines that can be displayed as two clear echo signals.
Unit: mm.
3.3
Depth of penetration
The distance between the farthest target line and the acoustic window in the longitudinal linear target cluster that can be clearly imaged in a phantom.
Unit: mm.
3.4
Dead zone
The distance between the phantom scanning surface (acoustic window) and the closest phantom target line that can be clearly imaged.
Unit: mm.
3.5
Slice thickness
At a specified depth of a phantom, the thickness of the tissue-mimicking material which displays acoustic information perpendicular to the scan plane.
Unit: mm.
3.6
Nominal frequency
The system ultrasonic operating frequency announced by the designer or manufacturer.
3.7
Scan plane
The plane in which the ultrasonic scan lines are located.
3.8
Phantom
The B-mode ultrasound performance testing device consisting of tissue-mimicking material and one or more target structures embedded therein.
3.9
Phantom scanning surface
During testing, the surface where the phantom is coupled to the probe.
3.10
Tissue-mimicking material, TMM
A material whose ultrasonic propagation speed (acoustic speed), reflection, diffusion, and attenuation characteristics are similar to those of soft tissue in the 0.5 MHz to 15 MHz frequency range.
