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YY/T 0750-2018: Ultrasonics--Physiotherapy systems--Field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz
Status: Valid YY/T 0750: Evolution and historical versions
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Ultrasonics--Physiotherapy systems--Field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz
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YY/T 0750-2018
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Ultrasonics. Physiotherapy systems. Field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz
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Basic data | Standard ID | YY/T 0750-2018 (YY/T0750-2018) | | Description (Translated English) | Ultrasonics--Physiotherapy systems--Field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 46,472 | | Date of Issue | 2018-09-21 | | Date of Implementation | 2019-09-26 | | Older Standard (superseded by this standard) | YY/T 0750-2009 | | Issuing agency(ies) | State Drug Administration | YY/T 0750-2018: Ultrasonics--Physiotherapy systems--Field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz
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Ultrasonics--Physiotherapy systems--Field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz
ICS 11.040.60
C41
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0750-2009
Ultrasound therapy equipment 0.5MHz~5MHz
Sound field requirements and measurement methods in the frequency range
(IEC 61689.2013, MOD)
Published on.2018-09-21
Implementation of.2019-09-26
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces the sound field requirements and measurements in the frequency range of 0.5MHz~5MHz for ultrasonic physiotherapy equipment of YY/T 0750-2009
method".
Compared with YY/T 0750-2009, the main technical changes of this standard are as follows.
--- In order to limit the possible cavitation, for the treatment head with ka≤20, the effective sound intensity is limited to 0.2W/cm2 during the hydrophone measurement;
--- Determine the coefficient of effective radiation area Fac, from 1.354 to 1.333;
--- Adopt the International System of Units in terms and definitions;
---Re-proofreading and sorting, the update definition is consistent with the YY/T 0865 series;
--- Correct a small number of calculation errors in data analysis;
--- Removed the use of inconsistencies and errors in the full text;
--- Revised references.
This standard uses the redrafting method to modify the frequency range of 0.5MHz~5MHz using IEC 61689.2013 "ultrasound physiotherapy equipment".
Sound field requirements and measurement methods.
The technical differences between this standard and IEC 61689.2013 and their reasons are as follows.
---About the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory References”, and the specific adjustments are as follows.
● Replace the IEC 60601-1 referenced by IEC 61689.2013 with GB 9706.1 modified;
● Replace IEC 60601-2-5 referenced by IEC 61689.2013 with GB 9706.7 modified.
The documents in China that have a consistent correspondence in the normatively cited international documents in this standard are as follows.
---GB/T 7966-2009 Acoustic ultrasonic power measurement radiation balance method and performance requirements (IEC 61161.2006,
IDT);
---YY/T 0865.1-2011 Ultrasonic hydrophones - Part 1. Measurement and characterization of medical ultrasound fields below 40 MHz
(IEC 62127-1.2007, IDT).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is determined by the National Medical Electrical Apparatus Standardization Technical Committee Medical Ultrasound Equipment Standardization Subcommittee (SAC/TC10/SC2)
Return to the mouth.
This standard was drafted. Hubei Medical Device Quality Supervision and Inspection Institute.
The main drafters of this standard. Wang Zhiwei, Jiang Shilin, warm.
The previous versions of the standards replaced by this standard are.
---YY/T 0750-2009.
Introduction
In the medical field, low megahertz ultrasound is widely used for physiotherapy purposes. This type of equipment is commonly called a high frequency electric power generator.
It is constructed for the hand-held treatment head of the application head. The treatment head contains a transducer that typically uses a disk-shaped piezoelectric material to convert electrical energy into super
Sound waves, the treatment head is often designed to come into contact with the human body.
Ultrasound therapy equipment 0.5MHz~5MHz
Sound field requirements and measurement methods in the frequency range
1 Scope
This standard specifies the measurement and characterization methods for the output of ultrasonic physiotherapy equipment based on the benchmark test method, based on the benchmark test method
Characteristics specified by the manufacturer of acoustic physiotherapy equipment, safety guidelines for ultrasonic sound fields generated by ultrasonic physiotherapy equipment, super based on routine test methods
Measurement and characterization methods for the output of acoustic physiotherapy equipment and acceptance criteria for the output of ultrasonic physiotherapy equipment based on conventional test methods.
This standard is applicable to the continuous or quasi-continuous wave generated by the ultrasonic transducer in the frequency range of 0.5MHz~5MHz.
Ultrasound equipment for therapeutic purposes.
This standard only covers the use of a single planar circular non-focusing transducer in each treatment head to produce a non-scan perpendicular to the end of the treatment head.
Ultrasound physiotherapy equipment for beams.
This standard does not include the treatment parameters and methods of use of ultrasound physiotherapy equipment.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1.1988, IDT)
GB 9706.7 Medical electrical equipment - Part 2-5. Particular requirements for safety of physiotherapy equipment (IEC 60601-2-5.2000, IDT)
IEC 61161.2013 Ultrasonic sound power measurement Radiation balance and performance requirements (Ultrasonics-Powermeasure-
ment-Radiationforcebalancesandperformancerequirements)
IEC 62127-1.2007 Amendment 1.2013 Ultrasonic hydrophones - Part 1 . Measurements of medical ultrasonic fields below 40 MHz
And feature depiction (Ultrasonics-Hydrophones-Part 1. Measurementand characterizationofmedicalultra-
sonicfieldsupto40MHzAmendment1.2013)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Absolute maximum rated output power absolutemaximumratedoutputpower
Rated output power, total uncertainty of rated output power at 95% probability of inclusion, rated network voltage fluctuation ±10%
The sum of the three of the maximum increase in rated output power.
Note 1. The possibility of fluctuation of rated output power under the condition of rated network voltage fluctuation ±10% should be adjusted by adjusting the power supply between the network and the ultrasonic physiotherapy equipment.
The output transformer is verified for verification. See A.2 for detailed guidelines.
Note 2. The absolute maximum rated output power unit is expressed in watts (W).
3.2
Effective area factor activeareacoefficient
The effective working area gradient m is divided by the quotient of the beam cross-sectional area ABCS (0.3) at 0.3 cm from the end face of the treatment head.
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