GB 10152-2009 PDF English
GB 10152: Historical versions
| Standard ID | USD | BUY PDF | Delivery | Standard Title (Description) | Status |
| GB 10152-2009 | 155 | Add to Cart | Auto, 9 seconds. | B mode ultrasonic diagnostic equipment | Valid |
| GB 10152-1997 | 799 | Add to Cart | 5 days | B mode ultrasonic diagnostic equipment | Obsolete |
| GB 10152-1988 | RFQ | ASK | 3 days | 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/GB10152-2009NATIONAL 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... 22Foreword
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 equipment1 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.
