YY 0846-2011Laser therapeutic equipment - Ho: YAG laser equipment (English PDF)
激光治疗设备 掺钬钇铝石榴石激光治疗机
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY 0846-2011 is the English-translated version of 激光治疗设备 掺钬钇铝石榴石激光治疗机.
YY 0846-2011 is the Chinese standard "Laser therapeutic equipment - Ho: YAG laser equipment". Its scope clause reads: 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. Its clauses include terms and definitions.
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Document preview — YY 0846-2011
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C41
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 7247.1Safety of laser products - Part 1: Equipment classification and requirements
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.19Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- YY/T 0758General requirements for medical laser fiber
GB 9706.20 · GB/T 17736-1999 · ISO 11146
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Related Standards
GB 7247.1-2012 — Safety of laser products - Part 1: Equipment classification and requirements
GB 9706.19-2000 — Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
GB 9706.201-2020 — Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
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YY 0846-2011
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