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YY/T 1629.4-2020Cutting tools for electric osseous tissue surgical equipment - Part 4: Milling cutter (English PDF)

电动骨组织手术设备刀具第4部分：铣刀

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 27, 2020

Implementation date

September 1, 2021

Scope

YY/T 1629.4-2020 is the English-translated version of 电动骨组织手术设备刀具第4部分：铣刀.

YY/T 1629.4-2020 is the Chinese pharmaceutical industry standard for the milling cutters used as cutting tools on electric bone tissue surgery equipment, the burs driven in rotation to mill bone.

It is the fourth part of the YY/T 1629 series and gives the terms and definitions, the materials, the requirements and the test methods, the instructions and the marking, covering the geometry and the cutting edges of the head, the shank and its fit to the handpiece, the hardness and corrosion resistance, the cutting performance and the heat produced.

Cutters that both mill and drill must also meet this part. Issued on 27 September 2020, it has applied since 1 September 2021.

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Document preview — YY/T 1629.4-2020

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

Foreword
1 Scope
2 Normative references
3 Terms and definitions YY/T 0752 and the following

Foreword

YY/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.

1 Scope

This 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 references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. 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 China

3 Terms and definitions YY/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.

......
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

Similar standards

YY/T 1629.3-2022|YY/T 1629.6-2021|YY/T 1629.5-2020|YY/T 1853-2022|GB/T 32800.2-2023|YY/T 1797-2021

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