YY 0592-2016 English PDF (YY0592-2016)

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YY 0592-2016: High intensity focused ultrasound therapy system
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
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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 sec...