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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

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