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YY/T 0906-2013 English PDF

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YY/T 0906-2013: Performance testing methods for B-mode ultrasonic diagnostic equipment with intra-cavity probe
Status: Valid
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YY/T 0906-2013209 Add to Cart 3 days Performance testing methods for B-mode ultrasonic diagnostic equipment with intra-cavity probe Valid

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Basic data

Standard ID: YY/T 0906-2013 (YY/T0906-2013)
Description (Translated English): Performance testing methods for B-mode ultrasonic diagnostic equipment with intra-cavity probe
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C41
Classification of International Standard: 11.040.50; 11.040.55
Word Count Estimation: 9,982
Quoted Standard: GB 10152-2009
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the terms and definitions, test conditions and test methods for intracavitary probe connected with B-mode ultrasound diagnostic equipment. This standard applies to the nominal frequency ultrasound in the 1. 5MHz ~ 15. 0MHz range, m

YY/T 0906-2013: Performance testing methods for B-mode ultrasonic diagnostic equipment with intra-cavity probe


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Performance testing methods for B-mode ultrasonic diagnostic equipment with intra-cavity probe ICS 11.040.50; 11.040.55 C41 People's Republic of China pharmaceutical industry standards B-mode ultrasound diagnostic equipment performance test method Mating cavity probe Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Foreword

This section Press GB/T 1.1-2009 given rule drafting. This standard was proposed by the China Food and Drug Administration. This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2) Centralized. This standard was drafted. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Wang Zhijian, Jiang Shilin. B-mode ultrasound diagnostic equipment performance test method Mating cavity probe

1 Scope

This standard specifies the terms and definitions, test conditions and test methods for mating cavity probe B-mode ultrasound diagnostic equipment. This standard applies to nominal frequency ultrasound in the range of 1.5MHz ~ 15.0MHz, mating cavity probe B-type ultrasonic diagnostic equipment (Hereinafter referred to as B -).

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 10152-2009 B-type ultrasonic diagnostic equipment

3 Terms and Definitions

GB 10152-2009 define the following terms and definitions apply to this document. 3.1 Intracavitary probe intra-cavityprobe And B-mode ultrasound diagnostic equipment, for ease of use and specially designed body cavity of a class of ultrasonic probe. Common cavity probe are. Vaginal probe (intra-vaginalultrasoundprobe), rectal probe (trans-rectalultrasoundprobe), transesophageal probe (Trans-esophagealechocardiographyultrasoundprobe).

4 Test Conditions

4.1 Overview Particularity cavity probe, the probe cavity to facilitate the specification of test methods, formulated standards. Standard test method provided Is the GB 10152 test method specified in supplementary and refined. Performance test methods not covered by this standard, a direct reference to the GB 10152 content. 4.2 Test phantom Target structure and arrangement of the phantom should be able to meet the requirements of this standard test method, see informative Annex A. 4.3 Test Settings The performance at the nominal frequency of the probe under test. Operation, the ultrasonic diagnostic apparatus in accordance with the instructions of all kinds Control terminal is set in place, the equipment in the normal clinical diagnostic use, throughout the performance measurement process to keep control End system to the best condition. Transducer probe lumen having a plurality of imaging were tested for each imaging transducer.
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