YY/T 1629.2-2018Cutting tools for electric osseous tissue surgical equipment - Part 2: Cranial perforator (English PDF)
电动骨组织手术设备刀具 第2部分：颅骨钻头
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
November 7, 2018
Implementation date
November 1, 2019
Scope
YY/T 1629.2-2018 is the English-translated version of 电动骨组织手术设备刀具 第2部分：颅骨钻头.
YY/T 1629.2-2018 is the Chinese pharmaceutical industry standard for the cranial perforator drill used on electric bone tissue surgery equipment, the bit with a mechanical clutch that stops it as soon as the skull is breached, made of an inner and an outer drill.
It is the second part of the YY/T 1629 series and gives the materials, the requirements, the test methods, the instructions and the marking, covering the geometry and the sharpness of the cutting parts, the reliability of the clutch release, the shank and its fit, the hardness and corrosion resistance and the heat produced in use. Issued on 7 November 2018, it has applied since 1 November 2019.
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Document preview — YY/T 1629.2-2018
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
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.
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 document. 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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1220Stainless steel bars
- GB/T 4340.1-2009Metallic materials - Vickers hardness test - Part 1: Test method
- GB/T 6682Water for analytical laboratory use - Specification and test methods
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 16886.1-2011Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.5-2017Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
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Related Standards
GB/T 1220-2007 — Stainless steel bars
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 16886.5-2017 — Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
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YY/T 1629.2-2018
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