YY/T 0906-2013Performance testing methods for B-mode ultrasonic diagnostic equipment with intra-cavity probe (English PDF)
B型超声诊断设备性能试验方法配接腔内探头
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 0906-2013 is the English-translated version of B型超声诊断设备性能试验方法配接腔内探头.
YY/T 0906-2013 is the Chinese pharmaceutical industry standard that gives the performance testing methods for B-mode ultrasonic diagnostic equipment fitted with an intra-cavity probe.
It specifies the terms and definitions, the test conditions and the test methods for equipment whose nominal frequency lies between 1.5 MHz and 15.0 MHz, covering the detail and contrast resolution, the depth of penetration, the geometric accuracy of the image, the dead zone and the uniformity of the display. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 0906-2013
National Standard of the People's Republic of China
- ICS
- 11.040.50; 11.040.55
- Classification
- C 41
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions GB 10152-2009 define the following
- 4 Test Conditions
Foreword
This section Press GB/T 1.1-2009 given rule drafting.
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
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB 10152-2009 — B mode ultrasonic diagnostic equipment
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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