YY 0983-2016Therapeutic laser equipment - Ruby laser equipment for therapy (English PDF)
激光治疗设备 红宝石激光治疗机
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 23, 2016
Implementation date
January 1, 2018
Scope
YY 0983-2016 is the English-translated version of 激光治疗设备 红宝石激光治疗机.
YY 0983-2016 is the Chinese standard "Therapeutic laser equipment - Ruby laser equipment for therapy". Its scope clause reads: This standard specifies the composition and basic parameters, requirements, test methods, inspection rules and standards of the ruby (Cr3.
Al2O3) laser treatment machine. Chi, labels, packaging and other requirements. This standard applies to the wavelength of 694.3nm ruby laser treatment machine (hereinafter referred to as treatment machine).
The treatment machine utilizes ruby lasers The principle of selective light and heat, for the surface treatment. Its clauses include normative reference documents; composition with basic parameters.
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Document preview — YY 0983-2016
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 composition with basic parameters
- 3.1 composition of the treatment machine
1 Scope
This standard specifies the composition and basic parameters, requirements, test methods, inspection rules and standards of the ruby (Cr3. Al2O3) laser treatment machine.
Chi, labels, packaging and other requirements.
This standard applies to the wavelength of 694.3nm ruby laser treatment machine (hereinafter referred to as treatment machine). The treatment machine utilizes ruby lasers
The principle of selective light and heat, for the surface treatment.
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 9706.20 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
GB/T 26599.1 Laser and laser related equipment - Test methods for laser beam width, divergence angle and beam transmission ratio - Part 1
Points. no astigmatism and simple astigmatism
General technical conditions for medical foot switch
3 composition with basic parameters
3.1 composition of the treatment machine
The composition of the treatment machine is as follows.
a) ruby lasers;
b) laser power supply;
c) beam transmission system;
d) control and safety protection systems;
e) cooling system;
f) application of accessories (including application of hand tools, etc.);
g) aiming optical device (if any);
h) Other accessories (which may include goggles, foot switches, etc.).
3.2 basic parameters of the treatment machine
The manufacturer shall list the following basic parameters in the registered product standard.
a) treatment of laser wavelength;
......
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
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/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 26599.1Lasers and laser-related equipment -- Test methods for laser beam widths, divergence angles and beam propagation ratios -- Part 1: Stigmatic and simple astigmatic beam
GB 9706.20 · GB/T 17736-1999
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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 0983-2016
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