YY 0846-2011 English PDF

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YY 0846-2011: Laser therapeutic equipment. Ho: YAG laser equipment
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0846-2011	279	Add to Cart	3 days	Laser therapeutic equipment. Ho: YAG laser equipment	Valid

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Basic data

Standard ID: 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: 12,112
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
Regulation (derived from): State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies): State 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

---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 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. ......

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