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YY 0845-2011

Chinese Standard: 'YY 0845-2011'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0845-2011English219 Add to Cart Days<=3 Laser therapeutic equipment. Diode laser equipment for photodynamic therapy Valid YY 0845-2011
YY 0845-2011Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

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Detail Information of YY 0845-2011; YY0845-2011
Description (Translated English): Laser therapeutic equipment. Diode laser equipment for photodynamic therapy
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C41
Classification of International Standard: 11.040.60
Word Count Estimation: 11,110
Date of Issue: 2011-12-31
Date of Implementation: 2013-06-01
Quoted Standard: GB/T 191; GB 7247.1; GB 9706.1; GB 9706.19-2000; GB 9706.20; GB/T 14710-2009; GB/T 17736-1999; YY/T 0758-2009; YY 91057-1999; ISO 11146-1; ISO 11146-2
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 semiconductor laser photodynamic therapy machine terminology and definitions, product composition, the basic parameters, technical requirements, test methods and inspection rules and other requirements. This standard applies to semiconductor laser photodynamic therapy unit (hereinafter referred to as treatment machine), the treatment machine uses a specific wavelength of laser photochemical effects photosensitizer for photodynamic therapy clinical units.


YY 0845-2011
Laser therapeutic equipment.Diode laser equipment for photodynamic therapy
ICS 11.040.60
C41
People's Republic of China pharmaceutical industry standards
Laser therapy equipment
The semiconductor laser photodynamic therapy machine
Lasertherapeuticequipment-
Diodelaserequipmentforphotodynamictherapy
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.
This standard GB 9706.1 "Medical Electrical Equipment Part 1: General requirements for safety", GB 9706.19 "Medical Electrical Equipment
Part 2: Particular requirements for the safety of endoscopic equipment ", GB 9706.20" Medical electrical equipment Part II: diagnostic and therapeutic laser equipment safety
Full-specific requirements "and GB 7247.1" Safety of laser products - Part 1: Equipment Classification, Requirements and User's Guide. "
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 by the State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Device Testing, Shenzhen
City Leimai Technology Co., Ltd. is responsible for drafting.
The main drafters of this standard: Yeyue Shun, Han Jian City, Du Yi, Du Kun.
Laser therapy equipment
The semiconductor laser photodynamic therapy machine
1 Scope
This standard specifies the terms and definitions of the semiconductor laser photodynamic therapy machine, the product composition, the basic parameters, technical requirements, test methods and
Inspection rules and other requirements.
This standard applies to the semiconductor laser photodynamic therapy machine (hereinafter referred to as the treatment machine), the treatment machine uses a specific wavelength of laser and light-sensitive
Agent photochemical effect, for clinical units photodynamic therapy.
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 Medical Electrical Equipment Part 1: General requirements for safety
GB 9706.19-2000 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 14710-2009 medical electrical environmental requirements and test methods
GB/T 17736-1999 laser safety goggles main parameters of the test method
YY/T 0758-2009 General Requirements for treatment with the laser fiber
YY 91057-1999 medical foot switch General technical conditions
Test Method ISO 11146 (all parts) and laser-related equipment laser beam widths, divergence angles and beam propagation ratios
(Lasersandlaser-relatedequipment-Testmethodsforlaserbeam widths, divergenceanglesand
beampropagationratios)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Photodynamic therapy photodynamictherapy
With the help of the photosensitizer, the participation of oxygen molecules in the light-induced chemical reaction by the light irradiation sensitization caused by this chemical reaction
It should go to destroy diseased tissue for therapeutic purposes.
3.2
Wavelength spectrum width spectralbandwidth
Spectral power (or energy) for half the peak wavelength interval corresponding to the maximum premises.
3.3
Therapeutic laser fiber therapeuticlaserfiber
In the optical fiber laser transmission medium, through the use of light treatment products.
Related standard:   YY 0844-2011  YY 0846-2011
   
 
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