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YY 0983-2016: Therapeutic laser equipment. Ruby Laser equipment for therapy
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| YY 0983-2016 | English | 239 |
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Therapeutic laser equipment. Ruby Laser equipment for therapy
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YY 0983-2016
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Basic data | Standard ID | YY 0983-2016 (YY0983-2016) | | Description (Translated English) | Therapeutic laser equipment. Ruby Laser equipment for therapy | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 12,195 | | Date of Issue | 2016-03-23 | | 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 91057-1999 | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the ruby ??(Cr3 +: A12O3) laser treatment machine composition and basic parameters, requirements, test methods, inspection rules and signs, labels, packaging and other requirements. This standard applies to the wavelength of 694.3nm ruby ??laser therapy machine (hereinafter referred to as the treatment machine). The treatment machine utilizes the selective photothermal principle of the ruby ??laser for surface treatment. | YY 0983-2016: Therapeutic laser equipment. Ruby Laser equipment for therapy---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.
Therapeutic laser equipment.Ruby Laser equipment for therapy
ICS 11.040.60
C41
People's Republic of China Pharmaceutical Industry Standard
Laser treatment equipment ruby laser treatment machine
2016-03-23 release
2018-01-01 implementation
State Food and Drug Administration issued
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 release of this document
The Agency does not assume responsibility for identifying 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. Zhejiang Medical Devices Testing Institute, Tianjin Tian Da Precision Technology Co., Ltd.
The main drafters of this standard. Du Kun, Ye Yue Shun, Sa Yu, Ye Zhisheng, Ren Guoquan.
Laser treatment equipment ruby laser treatment machine
1 Scope
This standard specifies the composition and basic parameters, requirements, test methods, inspection rules and standards of the ruby (Cr3. Al2O3) laser treatment machine.
Chi, labels, packaging and other requirements.
This standard applies to the wavelength of 694.3nm ruby laser treatment machine (hereinafter referred to as treatment machine). The treatment machine utilizes ruby lasers
The principle of selective light and heat, for the surface treatment.
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 conditions for medical foot switch
3 composition with basic parameters
3.1 composition of the treatment machine
The composition of the treatment machine is as follows.
a) ruby lasers;
b) laser power supply;
c) beam transmission system;
d) control and safety protection systems;
e) cooling system;
f) application of accessories (including application of hand tools, etc.);
g) aiming optical device (if any);
h) Other accessories (which may include goggles, foot switches, etc.).
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 wavelength;
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