YY 1301-2016Therapeutic laser equipment - Er: YAG laser equipment for therapy (English PDF)

1 Scope

This standard specifies the basic parameters and product composition of erbium (Er. YAG) laser treatment machine, technical requirements, test methods and marking standards

Sign, packaging and other requirements.

This standard applies to erbium (Er. YAG) laser treatment machine with a wavelength of 2.94µm (hereinafter referred to as treatment machine). The treatment machine is erbium

Light pulse on human tissue vaporization, carbonation and coagulation, to achieve the purpose of 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 Biological evaluation of medical devices - Part 1. Biological evaluation of medical devices GB/T 16886.1

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 11146-1 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 (Lasersandlaser-relatedequipmenttestmethodsforlaserbeamwidths, di- vergenceanglesandbeampropagationratios-Part 1. Stigmaticandsimpleastigmaticbeams)

ISO 11146-2 Laser and laser-related equipment - Test methods for laser beam width, divergence angle and beam transmission ratio - Part 2

Points. generalized astigmatism beam (Lasersandlaser-relatedequipmenttestmethodsforlaserbeamwidths, divergence anglesandbeampropagationratios-Part 2. Generalastigmaticbeams)

ISO /T R11146-3 Laser and laser-related equipment - Test method for laser beam width, divergence angle and beam transmission ratio.

Part. Intrinsic and geometric laser beam classification, transmission and detailed test method (Lasersandlaser-relatedequipment-Test methodsforlaserbeamwidths, divergenceanglesandbeampropagratratios-Part 3. Intrinsicand geometricallaserbeamclassification, propagationanddetailsoftestmethods)

3 product composition and basic parameters