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US$199.00 ยท In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1629.2-2018: Cutting tools for electric osseous tissue surgical equipment. Part 2: Cranial perforator Status: Valid
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| YY/T 1629.2-2018 | English | 199 |
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Cutting tools for electric osseous tissue surgical equipment. Part 2: Cranial perforator
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YY/T 1629.2-2018
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Basic data | Standard ID | YY/T 1629.2-2018 (YY/T1629.2-2018) | | Description (Translated English) | Cutting tools for electric osseous tissue surgical equipment. Part 2: Cranial perforator | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,176 | | Date of Issue | 2018-11-07 | | Date of Implementation | 2019-11-01 | | Quoted Standard | GB/T 1220; GB/T 4340.1-2009; GB/T 6682; GB/T 14233.1-2008; GB/T 16886.1-2011; GB/T 16886.5-2017; GB/T 16886.10-2017; YY/T 0149-2006; YY/T 0294.1; YY/T 0752-2016 | | Regulation (derived from) | Announcement No. 87 of 2018 by the State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the materials, requirements, test methods, instructions and labels for the skull drill bits for electric bone tissue surgical equipment. This standard is applicable to the skull bit (hereinafter referred to as the product) of the mechanical clutch type self-stopping function. The product usually consists of an inner drill bit, an outer drill bit, a clutch mechanism, and an interface. Other working methods of the skull drill can be selected according to the applicability. |
YY/T 1629.2-2018: Cutting tools for electric osseous tissue surgical equipment. Part 2: Cranial perforator ---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.
Cutting tools for electric osseous tissue surgical equipment.Part 2. Cranial perforator
ICS 11.040.30
C35
People's Republic of China Pharmaceutical Industry Standard
Electric bone tissue surgery equipment tool
Part 2. Skull drill
Part 2. Cranialperforator
Published on.2018-11-07
2019-11-01 implementation
State Drug Administration issued
Foreword
YY/T 1629 "Electric Bone Tissue Surgery Equipment Tool" is divided into 6 parts.
--- Part 1. Grinding head;
--- Part 2. Skull drill;
--- Part 3. Drill bits;
--- Part 4. Milling cutters;
---Part 5. saw blade;
--- Part 6. Scythe.
This part is the second part of YY/T 1629.
This part 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 issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is divided into the National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5)
Return to the mouth.
This section drafted by. Chongqing Xishan Technology Co., Ltd., Shanghai Medical Device Testing Institute, Chongqing Medical Device Quality Inspection
center.
The main drafters of this section. Zhang Jinbin, Xu Chao, Li Hongyuan, Wang Ganglin, Zhou Qing, Zheng Wenhao.
Electric bone tissue surgery equipment tool
Part 2. Skull drill
1 Scope
This part of YY/T 1629 specifies the materials, requirements, test methods, instructions and instructions for the scalpel bit of the electric bone tissue surgical equipment tool.
label.
This section applies to the mechanical clutch clutch drill bit self-stop function of the skull drill bit (hereinafter referred to as the product). The product usually consists of an inner drill bit and an outer drill bit.
The clutch mechanism and interface are composed of parts. Other working methods of the skull drill can be selected according to the applicability.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1220 stainless steel rod
GB/T 4340.1-2009 - Vickers hardness test for metallic materials - Part 1. Test methods (ISO 6507-1.2005, MOD)
GB/T 6682 Analytical laboratory water specifications and test methods
GB/T 14233.1-2008 Methods of test for infusions, blood trans
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
(ISO 10993-1.2009, IDT)
GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (ISO 10993-5.2009,
IDT)
GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test (ISO 10993-10.
2010, IDT)
YY/T 0149-2006 Test Method for Corrosion Resistance of Stainless Steel Medical Devices (ISO 13402.1995, MOD)
YY/T 0294.1 Surgical Instruments Metal Materials Part 1 Stainless Steel
YY/T 0752-2016 Electric bone tissue surgery equipment
People's Republic of China Pharmacopoeia.2015 Edition
3 Terms and definitions
The following terms and definitions defined in YY/T 0752-2016 apply to this document. For ease of use, the following is repeated
Certain terms and definitions in YY/T 0752-2016.
3.1
Skull drill cranialperforator
Powered by a mobile phone to make mechanical rotary motion, a tool for drilling a skull.
3.2
Mobile phone handpiece
A component that is held by an operator and that can drive the surgical tool held to achieve the surgical purpose. The phone can be integrated or split, split
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