YY/T 1629.3-2022Cutting tools for electric osseous tissue surgical equipment - Part 3: Drill (English PDF)
电动骨组织手术设备刀具 第3部分：钻头
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 18, 2022
Implementation date
June 1, 2023
Scope
YY/T 1629.3-2022 is the English-translated version of 电动骨组织手术设备刀具 第3部分：钻头.
YY/T 1629.3-2022 is the Chinese pharmaceutical industry standard for the drills used as cutting tools on electric bone tissue surgery equipment, with or without mechanical rotation of the tool itself.
It gives the terms and definitions, the structural types and the materials, then the requirements and the test methods, covering the geometry and the sharpness of the cutting part, the shank and its fit to the handpiece, hardness and corrosion resistance, the cutting performance on bone and the heat it produces, together with the instructions for use and the marking. Issued on 18 May 2022, it has applied since 1 June 2023.
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Document preview — YY/T 1629.3-2022
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions YY/T 0752 and the following
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.
This document is part 3 of YY/T 1629 "Electric Bone Tissue Surgery Equipment and Knives". YY/T 1629 has issued the following parts.
--- Part 1: Grinding head;
--- Part 2: Skull drill bits;
--- Part 3: Drill bits;
--- Part 4: Milling cutters;
--- Part 5: Saw blades;
--- Part 6: Files.
Introduction
The series of product standards of "Electric Bone Tissue Surgery Equipment and Knives" are divided into six parts. Supplement to "Preparation".
--- Part 1: Grinding head. The purpose is to standardize the safety and performance requirements of the grinding head in the electric bone tissue surgery equipment.
--- Part 2: Skull drill bits. The purpose is to standardize the safety and performance of the skull drill in the matching tool for electric bone tissue surgery equipment Require.
--- Part 3: Drill bits. The purpose is to standardize the safety and performance requirements of drill bits in electric bone tissue surgery equipment.
--- Part 4: Milling cutters. The purpose is to standardize the safety and performance requirements of milling cutters in electric bone tissue surgery equipment.
--- Part 5: Saw blades. The purpose is to standardize the safety and performance requirements of saw blades in electric bone tissue surgery equipment.
--- Part 6: Files. The purpose is to standardize the safety and performance requirements of the files in the electric bone tissue surgery equipment. Electric bone tissue surgery equipment knife Part 3: Drill Bits
1 Scope
This document specifies the terms and definitions, structural types, materials, requirements, test methods, descriptions of electric bone tissue surgery equipment cutter bits book and logotype.
This document is applicable to drills (with or without mechanical rotation) powered by electric bone tissue surgical equipment to perform drilling on bone tissue. hereinafter referred to as the product).
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date 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 Vickers Hardness Test for Metal Materials Part 1: Test Methods
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods
YY/T 0752 Electric bone tissue surgery equipment Pharmacopoeia of the People's Republic of China
3 Terms and Definitions YY/T 0752 and the following
terms and definitions apply to this document. For ease of use, the list is repeated below Some terms and definitions in YY/T 0752.
3.1 Drill
Powered by electric bone tissue surgical equipment to perform mechanical rotation motion, a tool for drilling bone tissue, usually composed of a drill body, a rod part, the interface structure part.
3.2 Mobile phone handpiece
A component held by an operator and capable of driving the held surgical tool for surgical purposes. The mobile phone can be integrated or split, split The type 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 and direction change mechanism.
3.3 Drill body
The part of the drill bit from the end of the chip flute to the chisel edge is composed of a drill tip, a margin and a chip flute, and is shaped like a twist.
3.4 Drill point
The cutting function part of the drill.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1220Stainless steel bars
- GB/T 4340.1Metallic materials - Vickers hardness test - Part 1: Test method
- GB/T 6682Water for analytical laboratory use - Specification and test methods
- GB/T 14233.1Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- YY/T 0752Electrical surgical equipment for osseous tissue
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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 14233.1-2022 — Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
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YY/T 1629.3-2022
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