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YY 0592-2016 (YY0592-2016)

YY 0592-2016_English: PDF (YY0592-2016)
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BASIC DATA
Standard ID YY 0592-2016 (YY0592-2016)
Description (Translated English) High intensity focused ultrasound therapy system
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C41
Classification of International Standard 11.040.50
Word Count Estimation 13,189
Date of Issue 1/26/2016
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY 0592-2005
Quoted Standard GB/T 191; GB/T 3947-1996; GB 9706.1-2007; GB/T 14710; GB/T 19890-2005; YY/T 0162.1-2009; YY 0505
Drafting Organization The State Food and Drug Administration Hubei Medical Device Quality Supervision and Inspection Center, Chongqing Haifu Medical Technology Co., Ltd., Wuxi Haiying Electronic Medical System Co., Ltd.
Administrative Organization National Standardization Technical Committee for Medical Electrical Equipment Standardization Technical Committee for Medical Ultrasound Equipment (SAC/TC 10/SC 2)
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This International Standard specifies the terminology and definitions, classification, requirements, test methods, inspection rules and labeling, packaging, transport and storage of high intensity focused ultrasound (HIFU) treatment systems. This standard applies to high-intensity focused ultrasound (HIFU) treatment systems that are used for in vitro focused high-intensity focused ultrasound ablation.

Standards related to: YY 0592-2016

YY 0592-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 41
Replacing YY 0592-2005
High intensity focused ultrasound therapy system
高强度聚焦超声(HIFU)治疗系统
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2018
Issued by. China Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Classification ... 6 
5 Requirements ... 7 
6 Test methods ... 10 
7 Inspection rules ... 17 
8 Marks, packaging, transport, storage ... 18 
Foreword
This Standard was drafted in accordance with the rules given in GB/T
1.1-2009.
Compared with YY 0592-2005, in addition to editorial modifications, the main
technical changes in this Standard are as follows.
This Standard replaces YY 0592-2005 High intensity focused ultrasound
(HIFU) therapy system.
- deleted the terms and definitions that overlap with other reference
standards (3.2, 3.3, 3.4, 3.5, 3.6, 3.7 of Edition 2005);
- added requirements for longitudinal positioning accuracy (see 5.5.2 of
this Edition);
- added relevant requirements for electromagnetic compatibility (see 5.11
of this Edition);
- deleted Annex A of Edition 2005.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of Subcommittee on Medical
Ultrasound Equipment of National Technical Committee on Medical
Appliances of Standardization Administration of China (SAC/TC10/SC2).
The drafting organizations of this Standard. China Food and Drug
Administration Hubei Medical Device Quality Supervision and Inspection
Center, Chongqing Haifu Medical Technology Co., Ltd., Wuxi Haiying
Electronic Medical System Co., Ltd.
Main drafters of this Standard. Jiang Shilin, Ye Fangwei, Wang Guoying, Li
Tao.
This Standard was issued on December 2005 for the first time.
High intensity focused ultrasound therapy system
1 Scope
This Standard specifies the terms and definitions, classification, requirements,
test methods, inspection rules as well as marks, packaging, transport and
storage for high intensity focused ultrasound therapy system.
This Standard applies to in-vitro focus high intensity focused ultrasound
(HIFU) therapy system (hereinafter referred to as HIFU therapy system). The
system is used for in-vitro high intensity focused ultrasound ablation therapy.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including
any amendments) applies.
GB/T 191, Packaging and storage marks
GB/T 3947-1996, Acoustical terminology
GB 9706.1-2007, Medical electrical equipment - Part 1. General
requirements for safety
GB/T 14710, Environmental requirement and test methods for medical
electrical equipment
GB/T 19890-2005, Acoustics - High intensity focused ultrasound (HIFU)
measurements of acoustic power and field characteristics
YY/T 0162.1-2009, Medical ultrasound equipment class series - Part 1. B
mode ultrasound diagnostic equipment
YY 0505, Medical electrical equipment - Part 1-2. General requirements for
safety - Collateral standards. Electromagnetic compatibility - Requirements
and tests
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB/T
3947-1996 and GB/T 19890-2005 and the followings apply.
3.1 high intensity focused ultrasound therapy system
a therapy system that focused ultrasound source consisting of cell transducer
or multivariate transducer array sends ultrasound; after the ultrasound gets
through acoustic media, it penetrates patient's body surface in an acceptable
sound intensity by human normal tissue and gathers energy on the target
tissue to cause its coagulation necrosis (or instantaneous inactivation)
3.2 acoustic pressure focal region
focal domain
it includes the space body surrounded by the interfaces in which the acoustic
pressure focus and its acoustic pressure value are 6 dB lower than acoustic
pressure peak (0 dB)
3.3 acoustic pressure focal area
on the acoustic pressure focal plane, the area enclosed by the focal point of
the acoustic pressure and its acoustic pressure level 6 dB lower than the
acoustic pressure peak (0 dB)
unit. square millimeter, mm2
3.4 transverse size of focal region
on an acoustic pressure focal plane, the distance between two points where
the straight line passing through the peak of the acoustic pressure crosses
the focal area interface
unit. millimeter, mm
NOTE. Focal domain horizontal size and vertical size of the focal field are called by a
joint name as “-6dB focal domain size (FWHM)” in GB/T 19890-2005.
3.5 longitudinal size of focal region
distance between two points where the beam axis intersects the focal field
interface
unit. millimeter, mm
3.6 major lobe (main lobe)
in acoustic pressure distribution of acoustic pressure in the focal plane,
including the lobe of the maximum of pulse acoustic pressure square integral
5.9 Water treatment facility
For HIFU therapy system with medium temperature control, degassing device,
the effects after therapy are required as follows.
a) water temperature control range and error shall comply with the
manufacturer's requirements;
b) oxygen dissolved of degassing water is not more than 4 mg/L.
5.10 Electrical safety requirements
In accordance with relevant requirements of GB 9706.1-2007 and other
applicable parallel or special safety standards.
5.11 Electromagnetic compatibility
In accordance with relevant requirements of YY 0505.
5.12 Environmental test requirements
The environmental test conditions for HIFU therapy system shall be in
accordance with GB/T 14710. The manufacturer shall specify the appropriate
test groups and test items in its corporate product standard. When the overall
environmental test is not feasible, the climatic environmental test and the
mechanical environmental test under the working conditions may not be
carried out. It shall only carry out the storage test for key parts (such as
ultrasonic power source, control part). Then check if the machine works
properly after assembly.
6 Test methods
6.1 Test environment
6.1.1 Ambient temperature. +10°C ~ +40°C; relative humidity. 30% ~ 75%;
atmospheric pressure range. 700hPa ~ 1060hPa; water cooling equipment
inlet temperature not higher than 25°C.
6.1.2 Test shall avoid external vibration, electromagnetic fields and other
interference.
6.2 Measurement system requirements
In accordance with Clause 5 of GB/T 19890-2005.
NOTE. The stability of the electrical power of testing HIFU therapy system is changed
from 10%/4h specified in GB/T 19890-2005 to 15%/4h.
the average acoustic intensity of special peak value according to equation (4).
where,
Ispta - the average acoustic intensity of special peak value, in Watts per square
meter (W/m2);
Urms,max2 - root mean square value of hydrophone output voltage at acoustic
pressure focus within pulse duration, in volts (V);
ρ - water density, in kilograms per cubic meter (kg/m3);
c - sound velocity in water, in meters per second (m/s);
ML - load sensitivity of free field cable end at acoustic working frequency of
hydrophone, in volts per pascal.
NOTE. In the actual measurements, the corresponding Urms,max2 can be calculated first
by the Ispta nominated by HIFU therapy system. Stop the test after the test value reaches
this value so as to protect the measuring hydrophone.
6.4.2 Measurement of spatial average value of time average acoustic
intensity within -6 dB acoustic beam area
Carry out according to the method specified in GB/T 19890-2005.
For HIFU therapy system working by continuous wave, when the maximum
acoustic pressure value of the calibrated hydrophone cannot meet the rated
output value of HIFU therapy system, in order to ensure the safety and
service life of the hydrophone, the testing system shall set a particular pulse
measurement working state in which the pulse duration is less than or equal
to 100 μs, pulse repetition frequency is less than 1 kHz (or working by
manually triggering a single pulse).
If the HIFU therapy system working by continuous wave cannot set a
particular pulse measurement working state, it shall measure the spatial
average value of time average acoustic intensity within -6 dB acoustic beam
area according to the following steps.
a) measure the maximum output acoustic power according to the method
in GB/T 19890-2005;
b) use hydrophone to perform two-dimensional linear step-by-step
scanning within focal plane of acoustic pressure (it may use the
hydrophone with uncalibrated sensitivity ...
...