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YY 1300-2016 English PDF

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YY 1300-2016: Therapeutic laser equipment - Pulsed Nd: YAG laser equipment for therapy
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 1300-2016	English	279	Add to Cart	3 days [Need to translate]	Therapeutic laser equipment - Pulsed Nd: YAG laser equipment for therapy	Valid	YY 1300-2016

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Standard similar to YY 1300-2016

YY/T 0937 YY/T 1601 YY/T 1090 YY/T 1919 YY 1301

Basic data

Standard ID	YY 1300-2016 (YY1300-2016)
Description (Translated English)	Therapeutic laser equipment - Pulsed Nd: YAG laser equipment for therapy
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C41
Classification of International Standard	11.040.60
Word Count Estimation	14,121
Date of Issue	2016-03-23
Date of Implementation	2018-01-01
Quoted Standard	GB/T 191; GB 7247.1; GB 9706.1; GB 9706.19-2000; GB 9706.20; GB/T 14710; GB/T 16886.1; GB/T 17736-1999; YY/T 0758; YY 1057; ISO 11146
Regulation (derived from)	Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies)	State Food and Drug Administration

YY 1300-2016: Therapeutic laser equipment - Pulsed Nd: YAG laser equipment for 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.
Therapeutic laser equipment - Pulsed Nd. YAG laser equipment for therapy ICS 11.040.60 C41 People's Republic of China Pharmaceutical Industry Standard Laser treatment equipment Pulse doped neodymium yttrium aluminum garnet laser treatment machine Therapeuticlaserequipment-PulsedNd. YAGlaser 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1). The drafting of this standard unit. Zhejiang Medical Device Testing Institute. The main drafters of this standard. Huang Dan, Du Kun, Jia Xiaohang, Ye Yue Shun, Ye Zhongchen, Kong Peng. Laser treatment equipment Pulse doped neodymium yttrium aluminum garnet laser treatment machine

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 τ 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.

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