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YY 0830-2011Ultrasonic therapy equipment for superficial tissue (English PDF)

浅表组织超声治疗设备

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY 0830-2011 is the English-translated version of 浅表组织超声治疗设备.

YY 0830-2011 is the Chinese standard "Ultrasonic therapy equipment for superficial tissue". Its scope clause reads: This standard specifies the terms and definitions superficial tissue ultrasound treatment equipment, requirements, composition and basic parameters, test methods, inspection rules. Its clauses include terms and definitions.

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Document preview — YY 0830-2011

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: C41

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and Definitions
3.

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

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY 0789|YY/T 0767|YY 0844|YY/T 0750|YY 0599

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