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YY 0830-2011: Ultrasonic therapy equipment for superficial tissue
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0830-2011 | English | 229 |
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Ultrasonic therapy equipment for superficial tissue
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YY 0830-2011
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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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