GB 10152-2009 PDF English
US$155.00 · In stock · Download in 9 secondsGB 10152-2009: B mode ultrasonic diagnostic equipment Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB 10152: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 10152-2009 | English | 155 |
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B mode ultrasonic diagnostic equipment
| Valid |
| GB 10152-1997 | English | 799 |
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5 days
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B mode ultrasonic diagnostic equipment
| Obsolete |
| GB 10152-1988 | English | RFQ |
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3 days
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B mode linear electronic scan ultrasonic diagnostic equipment
| Obsolete |
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GB 10152-2009: B mode ultrasonic diagnostic equipment---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB10152-2009
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.40.55; 11.040.50
C 41
Replacing GB 10152-1997
B mode ultrasonic diagnostic equipment
Issued on. NOVEMBER 15, 2009
Implemented on. DECEMBER 01, 2010
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of PRC;
Standardization Administration of PRC.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Requirements... 7
5 Test method... 12
6 Inspection rules... 18
Appendix A (Informative) Technical requirements for phantoms... 20
Appendix B (Informative) B-ultrasonics setting for performance test... 22
Foreword
All technical content of this standard is mandatory.
This standard replaces GB 10152-1997 "B mode ultrasonic diagnostic equipment".
The main changes of this standard, as compared with GB 10152-1997, are as follows.
- ADD 8 new definitions;
- In Chapter 4 "Requirements", ADD 5 technical index, including slice thickness,
perimeter and area measurement deviation, M-mode time display error, 3D
reconstruction volume calculation deviation, use functional requirements;
- The technical requirements in Table 1 are the minimum requirements for the
technical performance of the equipment, according to the probe type and nominal
frequency; the manufacturer can publish the requirements, which are better than
the above index, in the accompanying document;
- In Chapter 5 "Test methods", SPECIFY the corresponding test methods, for the
added technical index;
- SIMPLIFY Chapter 6 "Inspection rules"; DELETE the content of exit-factory
inspection;
- DELETE the contents of Chapter 7 "Marking and instructions for use", from the
original standard;
- Fully IMPLEMENT the general safety standard GB 9706.1; DELETE the original
normative appendix A "Safety"; CHANGE the original informative appendix C
"Technical requirements for phantoms" to appendix A, making certain
modifications;
- DELETE the original normative appendix B "Grading and performance
requirements of B mode ultrasonic diagnostic equipment". ADD the informative
appendix B "B-ultrasound settings during performance testing".
Appendix A and Appendix B of this standard are informative appendixes.
This standard was proposed by the State Food and Drug Administration.
This standard shall be under the jurisdiction of the National Standardization Technical
Committee of Medical Electrical Appliances (SAC/TC 10).
Drafting organization of this standard. National Wuhan Medical Ultrasonic Instrument
Quality Supervision and Testing Center.
The main drafters of this standard. Wang Zhijian, busy Anshi.
This standard replaces the standard previously issued as follows.
- GB 10152-1988, GB 10153-1988;
- GB 10152-1997.
B mode ultrasonic diagnostic equipment
1 Scope
This standard specifies the definition, requirements, test methods, inspection rules of B
mode ultrasonic diagnostic equipment (hereinafter referred to as B-ultrasonics).
This standard applies to B mode ultrasound diagnostic equipment, which has a nominal
frequency in the range of 1.5 MHz ~ 15 MHz, including the two-dimensional grayscale
imaging part of color Doppler ultrasonic diagnostic equipment (color ultrasonics).
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For the dated references, the subsequent amendments
(excluding corrections) or revisions do not apply to this Standard; however, parties who
reach an agreement based on this Standard are encouraged to study if the latest versions
of these documents are applicable. For undated references, the latest edition of the
referenced document applies.
GB 9706.1 Medical electrical equipment - Part 1.General requirements for safety
(GB 9706.1-2007, idt IEC 60601-1.1988)
3 Terms and definitions
The following terms and definitions apply to this standard.
The distance, between the phantom scanning surface (acoustic window) and the
nearest clearly imaged phantom target line.
4 Requirements
The deviation, between the acoustic operating frequency and the nominal frequency,
shall be within ±15%.
5 Test method
For variable frequency probes or broadband probes, if the manufacturer has special
requirements in the instruction manual, the probe frequency can also be set to the
optimum state for testing, according to the requirements of the instruction manual.
The measurement of the acoustic operating frequency and frequency range shall be
carried out, in accordance with the provisions of YY/T 1142.
6 Inspection rules
Product inspection is divided into exit-factory inspection and type inspection.
The inspection items and judgment rules of the exit-factory inspection are stipulated by
the manufacturer.
Appendix A
(Informative)
Technical requirements for phantoms
When carrying out the test of B-ultrasonics dead zone, penetration depth, axial
resolution, lateral resolution, accuracy of longitudinal and lateral geometrical position,
the technical parameters of the phantom, which is used in the test, are as follows.
Appendix B
(Informative)
B-ultrasonics setting for performance test
Various combinations of B-ultrasonics settings and probes make it impossible to test in
all combinations. Therefore, for each probe, it is only tested at the specified settings.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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