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YY 1475-2016: Laser therapeutic equipment - Q-Switched Nd: YAG laser equipment
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 1475-2016 | English | 259 |
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Laser therapeutic equipment - Q-Switched Nd: YAG laser equipment
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YY 1475-2016
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Basic data | Standard ID | YY 1475-2016 (YY1475-2016) | | Description (Translated English) | Laser therapeutic equipment - Q-Switched Nd: YAG laser equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 13,119 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2018-01-01 | | Quoted Standard | GB/T 191; GB 7247.1; GB 9706.1; GB 9706.20; GB/T 14710; GB/T 16886.1; GB/T 17736-1999; GB/T 26599.1; YY 1057 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the basic parameters and product composition, technical requirements, test methods, marking labels and packaging requirements of Q-switched Nd: YAG laser therapy machine. This standard applies to the wavelength of 1064 nm or multiplier 532 nm Q switch (using Q technology) doped neodymium yttrium aluminum garnet laser treatment machine. The treatment machine using laser and biological tissue selective absorption mechanism, the emblem of blasting to achieve therapeutic purposes. | YY 1475-2016: Laser therapeutic equipment - Q-Switched Nd: YAG laser equipment---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Laser treatment equipment - Q-Switched Nd. YAG laser equipment
ICS 11.040.60
C41
People's Republic of China Pharmaceutical Industry Standard
Laser treatment equipment Q switch doped neodymium yttrium aluminum garnet
Laser treatment machine
2016-01-26 release
2018-01-01 implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 product composition and basic parameters 1
4 requirements 2
5 Test Method 5
6 Inspection rules 8
7 logo, label, instruction manual 8
8 Packaging, transportation, storage 9
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1).
The drafting of this standard unit. Zhejiang Medical Device Testing Institute.
The main drafters of this standard. Ye Yue Shun, Du Kun, He Tao, Yu Zhenhua.
Laser treatment equipment Q switch doped neodymium yttrium aluminum garnet
Laser treatment machine
1 Scope
This standard specifies the basic parameters and product composition, technical requirements and test methods of Q-switched neodymium-yttrium aluminum garnet laser treatment machine.
And logo labels, packaging and other requirements.
This standard applies to the wavelength of 1064nm or frequency 532nm Q switch (using Q-switched technology) doped neodymium yttrium aluminum garnet laser treatment
Treatment machine (hereinafter referred to as treatment machine). The treatment machine uses laser and biological tissue selective absorption mechanism, micro-blasting to achieve treatment
purpose.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 packaging and storage icon
GB 7247.1 Safety of laser products - Part 1. Classification of equipment, requirements
Medical electrical equipment - Part 1. General requirements for safety GB 9706.1
GB 9706.20 Medical electrical equipment - Part 2. Diagnostic and therapeutic requirements for laser equipment safety
Environmental requirements and test methods for medical appliances GB/T
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
Methods for testing the main parameters of laser goggles GB/T 17736-1999
GB/T 26599.1 Laser and laser related equipment - Test methods for laser beam width, divergence angle and beam transmission ratio - Part 1
Points. no astigmatism and simple astigmatism
General technical condition of YY 1057 medical foot switch
3 product composition and basic parameters
3.1 part of the treatment machine
The components of the treatment machine are as follows.
a) Host. Nd-doped yttrium aluminum garnet solid-state lasers, laser power and control systems, Q-switching devices and cooling systems;
b) beam transmission system;
c) Application accessories. various application of hand tools;
d) laser goggles;
e) laser emission control switch.
3.2 basic parameters of the treatment machine
The manufacturer shall list the following basic parameters in the registered product standard.
a) treatment of laser wavelengths and patterns;
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