YY/T 1629.4-2020 English PDFUS$229.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1629.4-2020: Cutting tools for electric osseous tissue surgical equipment - Part 4: Milling cutter Status: Valid
Basic dataStandard ID: YY/T 1629.4-2020 (YY/T1629.4-2020)Description (Translated English): Cutting tools for electric osseous tissue surgical equipment - Part 4: Milling cutter Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.30 Word Count Estimation: 12,137 Date of Issue: 2020-09-27 Date of Implementation: 2021-09-01 Regulation (derived from): Announcement No. 108 (2020) of the National Medical Products Administration Issuing agency(ies): State Drug Administration YY/T 1629.4-2020: Cutting tools for electric osseous tissue surgical equipment - Part 4: Milling cutter---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. (Electric bone tissue surgery equipment knife Part 4: Milling cutter) ICS 11:040:30 C35 People's Republic of China Pharmaceutical Industry Standard Electric bone tissue surgery equipment knife: Part 4: Milling cutter 2020-09-27 release 2021-09-01 implementation Issued by the State Drug Administration ForewordYY/T 1629 "Electric Bone Tissue Surgery Equipment Knife" is divided into 6 parts: ---Part 1: Grinding head; ---Part 2: Skull drill; ---Part 3: Drill bits; ---Part 4: Milling cutter; ---Part 5: Saw blade; ---Part 6: File: This part is part 4 of YY/T 1629: This section was drafted in accordance with the rules given in GB/T 1:1-2009: Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents: This part was proposed by the State Drug Administration: This part is organized by the National Medical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5) Focus: Drafting organizations of this section: Chongqing Xishan Technology Co:, Ltd:, Shanghai Medical Device Testing Institute, Chongqing Medical Device Quality Inspection center: The main drafters of this section: Guo Yijun, Xu Chao, Meng Mingjiang, Yang Yongbo, Zhong Dingen, Zheng Wenhao: Electric bone tissue surgery equipment knife: Part 4: Milling cutter1 ScopeThis section specifies the terms and definitions, materials, requirements, test methods, instructions and identification of electric bone tissue surgical equipment cutters and milling cutters: This part is applicable to the milling process that conforms to the power provided by the electric bone tissue surgery equipment for mechanical rotation movement and the milling treatment of bone tissue: Knife (hereinafter referred to as the product): Milling cutters with milling and drilling functions should meet the requirements of this section:2 Normative referencesThe following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article Pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 1220 stainless steel rod GB/T 4340:1 Vickers hardness test for metallic materials Part 1: Test method GB/T 6682 Analytical laboratory water specifications and test methods GB/T 14233:1 Medical infusion, blood transfusion, and injection equipment inspection methods Part 1: Chemical analysis methods GB/T 16886:1-2011 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management GB/T 16886:5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Test GB/T 16886:10-2017 Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Test YY/T 0752 Electric bone tissue surgery equipment Pharmacopoeia of the People's Republic of China3 Terms and definitionsYY/T 0752 and the following terms and definitions apply to this document: For ease of use, YY/T 0752 is listed repeatedly below Some terms and definitions in 3:1 Millingcutter A tool that is powered by electric bone tissue surgery equipment for mechanical rotation motion and milling the bone tissue: Usually by the blade, rod Department and interface structure: 3:2 Mobile phone handpiece A component that is held by the operator and can drive the clamped surgical knife to achieve the purpose of surgery: The phone can be integrated or split, split The formula consists of a (power) handle that can provide power to the machine head, a machine head that clamps the tool, and (or) a variable speed changing mechanism: [YY/T 0752-2016, definition 3:5] 3:3 Cuttingpart Milling removes the structural part of the bone tissue, the number of blades varies, and the blade types usually have straight blades, spiral blades, etc: 3:4 Shaft The structural part that transmits mechanical power between the connecting blade and the interface: ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1629.4-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 1629.4-2020_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/T 1629.4-2020_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1629.4-2020_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. |