YY 0592-2016 PDF English
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| YY 0592-2016 | English | 165 |
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High intensity focused ultrasound therapy system
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| YY 0592-2005 | English | 839 |
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YY 0592-2016: High intensity focused ultrasound therapy system---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0592-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.50
C 41
Replacing YY 0592-2005
High intensity focused ultrasound therapy system
Issued on. JANUARY 26, 2016
Implemented on. JANUARY 1, 2018
Issued by. China Food and Drug Administration
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
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;
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
4 Classification
4.1 Product classification
4.2 Product composition
HIFU therapy system generally consists of the following devices (or parts).
5 Requirements
5.1 Sound field characteristics
5.1.2 Longitudinal size of focal region
It shall not exceed the nominal value announced by the manufacturer.
5.1.3 Maximum side lobe level
The side lobe amplitude at the acoustic pressure focal plane shall be more
than 8 dB less than the main lobe amplitude (focal acoustic pressure).
5.2 Sound working frequency deviation
The manufacturer shall publish the nominal operating frequency of the
transducer sound. The maximum deviation of the sound operating frequency
shall not exceed ±15% of the nominal value.
5.3 Ultrasonic power and control
5.3.1 The manufacturers shall publish the maximum output sound power
and deviation.
5.4 Localization device
5.4.1 If using ultrasound imaging equipment as localization device, the main
technical performance requirements are as follows.
5.4.2 If using other medical imaging equipment as localization device, its
technical performance shall meet the requirements for localization of HIFU
therapy system.
5.5 Positioning device
5.5.1 Movement range and error
The maximum stroke in each axis, the cumulative error and treatment head,
ultrasonic imaging equipment probe angle of the positioning device
(treatment head or patient support device) shall be consistent with the
manufacturer's instructions.
5.8 Appearance and structure
5.8.1 It shall look neat, in uniform color, no scars, scratches or other defects.
5.8.2 The control and adjustment mechanism shall be flexible and reliable,
no loose fastening parts.
5.8.3 Rubber, plastic parts shall have no blistering, cracking, deformation.
5.8.4 Sinks, water bags and water connections shall have no media
leakage.
5.9 Water treatment facility
For HIFU therapy system with medium temperature control, degassing device,
the effects after therapy are required as follows.
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.
6 Test methods
6.1 Test environment
6.2 Measurement system requirements
In accordance with Clause 5 of GB/T 19890-2005.
6.3 Measurement of acoustic field distribution characteristics
Since only the acoustic pressure relative value is required by the sound field
distribution characteristic test, it shall use hydrophone with uncorrected
sensitivity but less than 10% nonlinear distortion.
6.3.3 Measurement of maximum side lobe level
Find the second maximum (secondary maximum) in the distribution of
acoustic pressure effective value in the acoustic pressure focal plane.
Calculate the maximum side lobe level according to equation (2) in
accordance with requirements of 5.1.3.
6.4 Measurement of maximum acoustic intensity of focal region
6.4.1 Measurement of average acoustic intensity of special peak time
It shall use the hydrophone with calibrated sensitivity. Set the pulse duration
of testing HIFU therapy system less than or equal to 100 µs, pulse repetition
frequency less than 1 kHz.
6.5 Measurement of acoustic operating frequency deviation
The measurement of acoustic operating frequency shall be carried out
according to the method specified in 7.3.1.2 of GB/T 19890-2005.Its
deviation meets requirements of 5.2.
6.6 Ultrasound power and control
Respectively set the maximum value and the minimum value for output
acoustic intensity or acoustic power of HIFU therapy system. Detect the
acoustic intensity or acoustic power according to the method of GB/T 19890.
Calculate the detected data. The result shall comply with the requirements of
5.3.1 and 5.3.2.
6.13 Safety performance
Carry out according to relevant method of GB 9706.1-2007 and other
applicable parallel or particular safety standards.
6.14 Electromagnetic compatibility
Carry out in accordance with YY 0505.
6.15 Environmental test
Carry out according to the method and procedures specified in GB/T 14710.
7 Inspection rules
7.1 Exit-factory inspection
The number of sample, inspection items, determination rules of exit-factory
inspection shall be stipulated by the manufacturer in the corporate product
standard.
7.2 Type inspection
7.2.1 The type inspection shall be conducted in one of the following cases.
7.2.2 The number for type inspection is one. The inspection sample shall be
extracted from the qualified batches in exit-factory inspection.
7.2.3 The items of type inspection are all requirements specified in this
Standard.
8 Marks, packaging, transport, storage
8.1 Marks
8.1.1 Product mark
Each set of HIFU therapy system (or each part) shall be marked with the
following information in an appropriate and eye-catching place.
8.1.3 Random document
8.1.3.1 When each HIFU therapy system exits factory, the following
accompanying documents shall be included in the package.
8.2 Packaging
Packaging methods shall be specified by the manufacturer to ensure the
safety of the product during normal transport, storage.
8.3 Transport
The transport method shall be specified by the contract. It nevertheless shall
avoid rain and snow splashing and mechanical collision.
8.4 Storage
The warehouse for storage of HIFU therapy system shall be dry,
well-ventilated, with an ambient temperature of -5°C ~ 40°C, a relative
humidity less than 80%.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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