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YY 0846-2011

Chinese Standard: 'YY 0846-2011'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0846-2011English239 Add to Cart Days<=3 Laser therapeutic equipment. Ho: YAG laser equipment Valid YY 0846-2011
YY 0846-2011Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

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Detail Information of YY 0846-2011; YY0846-2011
Description (Translated English): Laser therapeutic equipment. Ho: 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: 12,189
Date of Issue: 2011-12-31
Date of Implementation: 2013-06-01
Quoted Standard: GB/T 191; GB 7247.1; GB 9706.1-2007; GB 9706.19; GB 9706.20; GB/T 14710; GB/T 17736-1999; YY/T 0758; YY 91057-1999; ISO 11146-1-2005; ISO 11146-2-2005; ISO/TR 11146-3-2004
Drafting Organization: Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Administrative Organization: National Standardization Technical Committee of Medical optics and instruments
Regulation (derived from): State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Proposing organization: State Food and Drug Administration
Issuing agency(ies): China Food and Drug Administration
Summary: This standard specifies the doped titanium -aluminum-garnet laser therapy machine memory requirements, test methods, marking, packaging, transport and storage, instruction manual. This standard applies to doped Cr, Tm, Ho ions in yttrium aluminum garnet (YAG) as the working medium of the laser emission wavelength of 2. 1um near laser treatment (hereinafter referred to as the treatment machine). Treatment machine can be used for human tissue cutting, vaporization, coagulation and in vivo gravel and so on.


YY 0846-2011
Laser therapeutic equipment.Ho: YAG laser equipment
ICS 11.040.60
C41
People's Republic of China pharmaceutical industry standards
Laser therapy equipment
Holmium-doped yttrium aluminum garnet laser treatment
Issued on: 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard safety requirements for full implementation of GB 9706.1-2007 "Medical Electrical Equipment Part 1: General requirements for safety"
GB 9706.20-2000 "Medical electrical equipment - Part 2: diagnostic and therapeutic laser equipment for the safety requirements" and GB 7247.1-
2001 "Safety of laser products - Part 1: Equipment classification, requirements and user guide" requirements.
GB/T 14710-2009 "medical electrical environmental requirements and test methods" of the standard.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee (SAC/TC103/SC1) centralized.
This standard was drafted: State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Unit
The inspection.
The main drafters of this standard: Qi Weiming, Yezhong Chen, Du Kun, Huang Dan.
Laser therapy equipment
Holmium-doped yttrium aluminum garnet laser treatment
1 Scope
This standard specifies the holmium-doped yttrium aluminum garnet laser treatment requirements, test methods, marking, packaging, transport and storage, instructions for use.
This standard applies to doping Cr, Tm, Ho ions in yttrium aluminum garnet (YAG) as the working medium, the wavelength of the laser emission at 2.1μm
Nearby laser treatment (hereinafter referred to as the treatment machine).
Treatment machine can be used for tissue cutting, vaporization, and coagulation in vivo gravel and the like.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 7247.1 Safety of laser products - Part 1 Equipment Classification, Requirements and User's Guide
GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety
GB 9706.19 Medical electrical equipment - Part 2: Safety of endoscopic equipment
GB 9706.20 Medical electrical equipment - Part 2: diagnostic and therapeutic laser equipment requirements for the safety
GB/T 14710 medical electrical environment requirements and test methods
GB/T 17736-1999 laser safety goggles main parameters of the test method
YY/T 0758 General Requirements for treatment with the laser fiber
Medical Foot beginning YY 91057-1999 General technical conditions
ISO 11146-1:2005 Test methods for laser and laser-related equipment laser beam widths, divergence angles and beam propagation than the first
Part 1: no astigmatism and simple astigmatic beams (Lasersandlaser-relatedequipment-Testmethodsforlaserbeam
widths, divergenceanglesandbeam propagationratios-Part 1: Stigmaticandsimpleastigmatic
beams)
ISO 11146-2:2005 Test methods for laser and laser-related equipment laser beam widths, divergence angles and beam propagation than the first
Part 2: Generalized astigmatic beam (Lasersandlaser-relatedequipment-Testmethodsforlaserbeam widths,
divergenceanglesandbeampropagationratios-Part 2: Generalastigmaticbeams)
ISO /T R11146-3:2004 Test methods for laser and laser-related equipment laser beam widths, divergence angles and beam propagation ratios
Part 3: Intrinsic and geometrical laser beam classification, transmission and detailed test methods (Lasersandlaser-relatedequipment-
Testmethodsforlaserbeamwidths, divergenceanglesandbeampropagationratios-Part 3: Intrinsic
andgeometricallaserbeamchassification, propagationanddetailsoftestmethods)
3 Terms and Definitions
The following terms and definitions apply to this document.
Related standard:   YY 0844-2011  YY 0845-2011
   
 
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