YY 1475-2016 English PDFUS$259.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 1475-2016: Laser therapeutic equipment - Q-Switched Nd: YAG laser equipment Status: Valid
Basic dataStandard ID: YY 1475-2016 (YY1475-2016)Description (Translated English): Laser therapeutic equipment - Q-Switched Nd: YAG laser equipment Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C41 Classification of International Standard: 11.040.60 Word Count Estimation: 13,119 Date of Issue: 2016-01-26 Date of Implementation: 2018-01-01 Quoted Standard: GB/T 191; GB 7247.1; GB 9706.1; GB 9706.20; GB/T 14710; GB/T 16886.1; GB/T 17736-1999; GB/T 26599.1; YY 1057 Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25 Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the basic parameters and product composition, technical requirements, test methods, marking labels and packaging requirements of Q-switched Nd: YAG laser therapy machine. This standard applies to the wavelength of 1064 nm or multiplier 532 nm Q switch (using Q technology) doped neodymium yttrium aluminum garnet laser treatment machine. The treatment machine using laser and biological tissue selective absorption mechanism, the emblem of blasting to achieve therapeutic purposes. YY 1475-2016: Laser therapeutic equipment - Q-Switched Nd: YAG laser equipment---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.Laser treatment equipment - Q-Switched Nd. YAG laser equipment ICS 11.040.60 C41 People's Republic of China Pharmaceutical Industry Standard Laser treatment equipment Q switch doped neodymium yttrium aluminum garnet Laser treatment machine 2016-01-26 release 2018-01-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 product composition and basic parameters 1 4 requirements 2 5 Test Method 5 6 Inspection rules 8 7 logo, label, instruction manual 8 8 Packaging, transportation, storage 9 ForewordThis 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. Ye Yue Shun, Du Kun, He Tao, Yu Zhenhua. Laser treatment equipment Q switch doped neodymium yttrium aluminum garnet Laser treatment machine1 ScopeThis standard specifies the basic parameters and product composition, technical requirements and test methods of Q-switched neodymium-yttrium aluminum garnet laser treatment machine. And logo labels, packaging and other requirements. This standard applies to the wavelength of 1064nm or frequency 532nm Q switch (using Q-switched technology) doped neodymium yttrium aluminum garnet laser treatment Treatment machine (hereinafter referred to as treatment machine). The treatment machine uses laser and biological tissue selective absorption mechanism, micro-blasting to achieve treatment purpose.2 normative reference documentsThe 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 condition of YY 1057 medical foot switch3 product composition and basic parameters3.1 part of the treatment machine The components of the treatment machine are as follows. a) Host. Nd-doped yttrium aluminum garnet solid-state lasers, laser power and control systems, Q-switching devices and cooling systems; b) beam transmission system; c) Application accessories. various application of hand tools; d) laser goggles; e) laser emission control switch. 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 wavelengths and patterns; ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 1475-2016_English be delivered?Answer: Upon your order, we will start to translate YY 1475-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY 1475-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY 1475-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |