YY 1300-2016Therapeutic laser equipment - Pulsed Nd: YAG laser equipment for therapy (English PDF)
激光治疗设备 脉冲掺钕钇铝石榴石激光治疗机
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 23, 2016
Implementation date
January 1, 2018
Scope
YY 1300-2016 is the English-translated version of 激光治疗设备 脉冲掺钕钇铝石榴石激光治疗机.
YY 1300-2016 is the Chinese standard "Therapeutic laser equipment - Pulsed Nd: YAG laser equipment for therapy". Its scope clause reads: This standard specifies the terms and definitions of the pulsed neodymium-doped yttrium aluminum garnet (Nd.
YAG) laser treatment machine, the basic parameters, requirements, test Law, sampling and marking, labeling, packaging and other requirements. This standard applies to the wavelength of 1064nm free oscillation pulse doped neodymium yttrium aluminum garnet laser treatment machine (hereinafter referred to as the treatment machine).
The therapeutic function of the biological tissue condensation, vaporization, carbonation, melting. This standard does not apply to Q-switch neodymium-doped yttrium aluminum garnet laser treatment machine. Its clauses include normative reference documents; terms and definitions.
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Document preview — YY 1300-2016
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 reference documents
- 3 terms and definitions
1 Scope
This standard specifies the terms and definitions of the pulsed neodymium-doped yttrium aluminum garnet (Nd. YAG) laser treatment machine, the basic parameters, requirements, test
Law, sampling and marking, labeling, packaging and other requirements.
This standard applies to the wavelength of 1064nm free oscillation pulse doped neodymium yttrium aluminum garnet laser treatment machine (hereinafter referred to as the treatment machine).
The therapeutic function of the biological tissue condensation, vaporization, carbonation, melting.
This standard does not apply to Q-switch neodymium-doped yttrium aluminum garnet laser treatment machine.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 packaging and storage icon
GB 7247.1 Safety of laser products - Part 1. Classification of equipment, requirements
Medical electrical equipment - Part 1. General requirements for safety GB 9706.1
GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for endoscopic equipment safety
GB 9706.20 Medical electrical equipment - Part 2. Diagnostic and therapeutic requirements for laser equipment safety
Environmental requirements and test methods for medical appliances GB/T GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
Methods for testing the main parameters of laser goggles GB/T 17736-1999
General requirements for laser fiber for therapeutic use YY/T 0758
General technical condition of YY 1057 medical foot switch
ISO 11146 Laser and laser-related equipment Laser beam width, divergence angle and beam transmission ratio test method (Laserand laser-relatedequipment-Testmethodsforlaserbeamparameters-Beam widths, divergenceangle andbeampropagationfactor)
3 terms and definitions
The following terms and definitions apply to this document.
3.1 Pulse full width pulseduration
The time difference between the rising edge of the pulse and the end of the falling edge.
3.2 Pulse full width pulsetrainduration
tau string
The time difference between the rising edge of the first sub-pulse in the burst and the end of the falling edge of the last sub-pulse.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 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 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 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 9706.1-2020 — 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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YY 1300-2016
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