YY/T 1629.4-2020 Cutting tools for electric osseous tissue surgical equipment - Part 4: Milling cutter
1 Scope
This part specifies the terms and definitions, materials, requirements, test methods, instructions and markings for milling cutters among cutting tools for electric osseous tissue surgical equipment.
This part is applicable to milling cutters (hereinafter referred to as products) that are powered by electric osseous tissue surgical equipment to perform mechanical rotary motion for milling osseous tissue. For milling cutters with milling and drilling functions, their milling function shall meet the requirements of this part.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 1220 Stainless steel bars
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
YY/T 0752 Electrical surgical equipment for osseous tissue
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0752 as well as the followings apply. For the convenience of application, some terms and definitions in YY/T 0752 are listed repeatedly as follows.
3.1
milling cutter
cutting tool that is powered by electric osseous tissue surgical equipment to perform mechanical rotary motion for milling osseous tissue, typically consisting of a cutting part, a shaft, and a coupling structure
3.2
handpiece
component held by an operator and capable of driving the clamped surgical cutting tool to achieve surgical purposes, which may be integrated or split type; a split-type handpiece is composed of a (power) handle that can provide power to the handpiece head, a handpiece head that clamps the cutting tool, and/or a speed and direction change mechanism
[YY/T 0752-2016, Definition 3.5]
3.3
cutting part
structural part that performs milling resection on osseous tissue, of which, the number varies, and the types usually include straight and spiral types
3.4
shaft
structural part that connects the cutting part to the coupling to transmit mechanical power
3.5
coupling
structural part that connects to the handpiece of the electric osseous tissue surgical equipment to obtain mechanical power
3.6
rotation speed
output rotation speed corresponding to a specific load of work within the range of the maximum output rotation speed at output end of the handpiece specified by the manufacturer
Note: It is revised from Definition 3.7, YY/T 0752-2016.
4 Materials of cutting part
4.1 The cutting part of the product may be made of stainless steel materials specified in GB/T 1220, tungsten carbide alloy, or other materials deemed suitable by the manufacturer.
4.2 The coating of the cutting part may be made of titanium nitride materials or other materials deemed suitable by the manufacturer.
5 Requirements
5.1 Appearance
5.1.1 The surfaces of the product (except for the portion used for tissue resection) shall be free from sharp edges and burrs.
5.1.2 The cutting part shall have clear edge geometry and shall be free from erosion, crimping, chipping, notch, pits, cracks, and similar defects.
5.1.3 The coated area of the cutting part shall have uniform and consistent color, with intact surface coating films, and well‑defined demarcation lines between coated and uncoated areas.
5.2 Dimensions of the cutting part
The manufacturer shall specify the requirements for the maximum diameter and the length of the cutting part. The maximum diameter of the cutting part and its tolerance shall meet those specified in Table 1.
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Materials of cutting part
5 Requirements
6 Test methods
7 Instructions and markings
YY/T 1629.4-2020 Cutting tools for electric osseous tissue surgical equipment - Part 4: Milling cutter
1 Scope
This part specifies the terms and definitions, materials, requirements, test methods, instructions and markings for milling cutters among cutting tools for electric osseous tissue surgical equipment.
This part is applicable to milling cutters (hereinafter referred to as products) that are powered by electric osseous tissue surgical equipment to perform mechanical rotary motion for milling osseous tissue. For milling cutters with milling and drilling functions, their milling function shall meet the requirements of this part.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 1220 Stainless steel bars
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
YY/T 0752 Electrical surgical equipment for osseous tissue
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0752 as well as the followings apply. For the convenience of application, some terms and definitions in YY/T 0752 are listed repeatedly as follows.
3.1
milling cutter
cutting tool that is powered by electric osseous tissue surgical equipment to perform mechanical rotary motion for milling osseous tissue, typically consisting of a cutting part, a shaft, and a coupling structure
3.2
handpiece
component held by an operator and capable of driving the clamped surgical cutting tool to achieve surgical purposes, which may be integrated or split type; a split-type handpiece is composed of a (power) handle that can provide power to the handpiece head, a handpiece head that clamps the cutting tool, and/or a speed and direction change mechanism
[YY/T 0752-2016, Definition 3.5]
3.3
cutting part
structural part that performs milling resection on osseous tissue, of which, the number varies, and the types usually include straight and spiral types
3.4
shaft
structural part that connects the cutting part to the coupling to transmit mechanical power
3.5
coupling
structural part that connects to the handpiece of the electric osseous tissue surgical equipment to obtain mechanical power
3.6
rotation speed
output rotation speed corresponding to a specific load of work within the range of the maximum output rotation speed at output end of the handpiece specified by the manufacturer
Note: It is revised from Definition 3.7, YY/T 0752-2016.
4 Materials of cutting part
4.1 The cutting part of the product may be made of stainless steel materials specified in GB/T 1220, tungsten carbide alloy, or other materials deemed suitable by the manufacturer.
4.2 The coating of the cutting part may be made of titanium nitride materials or other materials deemed suitable by the manufacturer.
5 Requirements
5.1 Appearance
5.1.1 The surfaces of the product (except for the portion used for tissue resection) shall be free from sharp edges and burrs.
5.1.2 The cutting part shall have clear edge geometry and shall be free from erosion, crimping, chipping, notch, pits, cracks, and similar defects.
5.1.3 The coated area of the cutting part shall have uniform and consistent color, with intact surface coating films, and well‑defined demarcation lines between coated and uncoated areas.
5.2 Dimensions of the cutting part
The manufacturer shall specify the requirements for the maximum diameter and the length of the cutting part. The maximum diameter of the cutting part and its tolerance shall meet those specified in Table 1.
Contents of YY/T 1629.4-2020
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Materials of cutting part
5 Requirements
6 Test methods
7 Instructions and markings
