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YY 0830-2011 English PDF

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YY 0830-2011: Ultrasonic therapy equipment for superficial tissue
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY 0830-2011229 Add to Cart 3 days Ultrasonic therapy equipment for superficial tissue Valid

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Basic data

Standard ID: YY 0830-2011 (YY0830-2011)
Description (Translated English): Ultrasonic therapy equipment for superficial tissue
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C41
Classification of International Standard: 11.040.60
Word Count Estimation: 10,184
Date of Issue: 2011-12-31
Date of Implementation: 2013-06-01
Quoted Standard: GB 9706.1; GB/T 7966-1-2009; GB/T 14710; GB/T 16540-1996; GB/T 19890-2005; GB 9706.15
Regulation (derived from): State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the superficial tissue ultrasound therapy equipment terminology and definitions, requirements, composition and basic parameters, test methods, inspection rules. 3. 1 This standard applies to the definition of superficial tissue ultrasound therapy equipment. This standard does not apply to YY 1090 involving ultrasound physiotherapy equipment. This standard does not apply to YY 0592 involving high-intensity focused ultrasound (HIFU) therapy system. This standard does not apply to YY/T 0644 involving ultrasound surgery system.

YY 0830-2011: Ultrasonic therapy equipment for superficial tissue

---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.
Ultrasonic therapy equipment for superficial tissue ICS 11.040.60 C41 People's Republic of China pharmaceutical industry standards Superficial tissue ultrasound treatment device Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard was proposed by the State Food and Drug Administration. This standard by the medical ultrasound equipment Standardization Technical Committee of the National Standardization Technical Committee centralized medical appliances. This standard was drafted. Chongqing into the sea of Ultrasound in Medicine Engineering Research Center Co., Ltd., Hubei State Food and Drug Administration medical devices Mechanical Quality Supervision and Inspection Center, Mianyang Sonic Electronics Co., Ltd. The main drafters of this standard. Yefang Wei, Wang Zhijian Chen Temple Song, Jiang Shilin, Regulus Kai, Li Tao, Su Qiang Hua. Superficial tissue ultrasound treatment device

1 Scope

This standard specifies the terms and definitions superficial tissue ultrasound treatment equipment, requirements, composition and basic parameters, test methods, inspection rules. 3.1 This standard applies to the definition of superficial tissue ultrasound treatment device (hereinafter referred to as "equipment"). This standard does not apply to ultrasound physiotherapy equipment YY 1090 involved. This standard does not apply to high-intensity focused ultrasound YY 0592 involved (HIFU) therapy system. This standard does not apply to the ultrasonic surgical system YY/T 0644 involved.

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 9706.1 Medical Electrical Equipment Part 1. General requirements for safety GB/T 7966-2009 of acoustic radiation force balance power measurement methods and performance requirements GB/T 14710 Medical electrical equipment environmental requirements and test methods Characterization of ultrasonic fields in the GB/T 16540-1996 Acoustics 0.5 ~ 15MHz frequency range and its measurement method hydrophone Measurement GB/T 19890-2005 Acoustics High Intensity Focused Ultrasound (HIFU) acoustic power field characteristics GB 9706.15 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard. Safety requirements for medical electrical systems

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Using Piezoelectric ultrasonic transducer as a sound source, emitting ultrasonic energy to the target tissue superficial to achieve tissue degeneration and (or) Necrosis treatment characteristics, and does not belong YY 1090, YY 0592 ultrasound treatment devices within and YY/T 0644 range. 3.2 Treatment head treatmenthead The ultrasonic transducer and the ultrasound assembly in a patient associated member constituted. Note. The first treatment is also known as application head. 3.3 Focal Plane focalsurface Focused ultrasound transducer sound field, perpendicular to the acoustic axis and including a sound pressure maximum point of the plane. 3.4 Focal plane distance focalsurfacedistance Treatment of head end face of the ultrasonic transmission from the window, and the treatment of head and focal plane. Symbol. d Unit. mm, mm.
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