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YY 0845-2011 English PDF

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YY 0845-2011: Laser therapeutic equipment. Diode laser equipment for photodynamic therapy
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YY 0845-2011English259 Add to Cart 3 days [Need to translate] Laser therapeutic equipment. Diode laser equipment for photodynamic therapy Valid YY 0845-2011

PDF similar to YY 0845-2011


Standard similar to YY 0845-2011

YY 0789   YY/T 0767   YY 0844   YY/T 0850   YY/T 0855.2   YY 0846   

Basic data

Standard ID 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 11,158
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
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 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

---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.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 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.

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