YY 0845-2011Laser therapeutic equipment - Diode laser equipment for photodynamic therapy (English PDF)
激光治疗设备 半导体激光光动力治疗机
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY 0845-2011 is the English-translated version of 激光治疗设备 半导体激光光动力治疗机.
YY 0845-2011 is the Chinese standard "Laser therapeutic equipment - Diode laser equipment for photodynamic therapy".
Its scope clause reads: 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. Its clauses include terms and definitions.
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Document preview — YY 0845-2011
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 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
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
Spectral power (or energy) for half the peak wavelength interval corresponding to the maximum premises.
3.3 Therapeutic laser fiber
In the optical fiber laser transmission medium, through the use of light treatment products.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 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 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.19-2000Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
- GB/T 14710-2009The environmental requirement and test methods for medical electrical equipment
- YY/T 0758-2009General 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 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
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