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YY 1301-2016 English PDF

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YY 1301-2016: Therapeutic laser equipment - Er: YAG laser equipment for therapy
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Basic data

Standard ID YY 1301-2016 (YY1301-2016)
Description (Translated English) Therapeutic laser equipment - Er: YAG 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 14,159
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; YY/T 0758; YY 1057; ISO 11146-1; ISO 11146-2; ISO/TR 11146-3
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 basic parameters and product composition, technical requirements, test face methods, marking labels and packaging requirements of erbium (Er: YAG) laser treatment machines. This standard applies to erbium (Er: YAG) laser therapy machine (hereinafter referred to as the therapeutic machine) with a wavelength of 2.94 m. The treatment machine through the erbium laser pulse on human tissue vaporization, carbonation and coagulation, to achieve the purpose of treatment.

YY 1301-2016: Therapeutic laser equipment - Er: YAG 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 - Er. YAG laser equipment for therapy ICS 11.040.60 C41 People's Republic of China Pharmaceutical Industry Standard Laser treatment equipment erbium laser treatment machine 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued

Foreword

The technical content of this standard is mandatory. 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 unit. Zhejiang Medical Device Testing Institute. The main drafters of this standard. Ye Yueshun, Du Kun, Jia Xiaohang, Han Jiancheng, Sun Yu. Laser treatment equipment erbium laser treatment machine

1 Scope

This standard specifies the basic parameters and product composition of erbium (Er. YAG) laser treatment machine, technical requirements, test methods and marking standards Sign, packaging and other requirements. This standard applies to erbium (Er. YAG) laser treatment machine with a wavelength of 2.94μm (hereinafter referred to as treatment machine). The treatment machine is erbium Light pulse on human tissue vaporization, carbonation and coagulation, to achieve the purpose of 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 Biological evaluation of medical devices - Part 1. Biological evaluation of medical devices GB/T 16886.1 Methods for testing the main parameters of laser goggles GB/T 17736-1999 General requirements for laser fiber for therapeutic use YY/T 0758 General technical condition of YY 1057 medical foot switch ISO 11146-1 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 (Lasersandlaser-relatedequipmenttestmethodsforlaserbeamwidths, di- vergenceanglesandbeampropagationratios-Part 1. Stigmaticandsimpleastigmaticbeams) ISO 11146-2 Laser and laser-related equipment - Test methods for laser beam width, divergence angle and beam transmission ratio - Part 2 Points. generalized astigmatism beam (Lasersandlaser-relatedequipmenttestmethodsforlaserbeamwidths, divergence anglesandbeampropagationratios-Part 2. Generalastigmaticbeams) ISO /T R11146-3 Laser and laser-related equipment - Test method for laser beam width, divergence angle and beam transmission ratio. Part. Intrinsic and geometric laser beam classification, transmission and detailed test method (Lasersandlaser-relatedequipment-Test methodsforlaserbeamwidths, divergenceanglesandbeampropagratratios-Part 3. Intrinsicand geometricallaserbeamclassification, propagationanddetailsoftestmethods)

3 product composition and basic parameters

3.1 part of the treatment machine Treatment machine components. a) erbium (Er. YAG) lasers; b) laser power and control systems; c) laser transmission system;

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