YY/T 1629.1-2018 Cutting tools for electric osseous tissue surgical equipment - Part1: Burs
1 Scope
This part of YY/T 1629 specifies the terms and definitions, materials, requirements, test methods, instructions, and labeling for burs among cutting tools used in conjunction with electric osseous tissue surgical equipment.
This part is applicable to burs (hereinafter referred to as products) that are powered by electric osseous tissue surgical equipment to perform mechanical rotary motion for grinding resection on osseous tissue.
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 2411-2008 Plastics and ebonite - Determination of indentation hardness by means of a durometer (shore hardness) (ISO 868:2003, IDT)
GB/T 4340.1-2009 Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2005, MOD)
GB/T 6406-2016 Superabrasive - Checking the grain size
GB/T 6408-2003 Super abrasive - Cubic boron nitride
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 11336-2004 Measurement of departures from straightness
GB/T 14233.1-2008 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 (ISO 10993-1:2009, IDT)
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999, IDT)
GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2002, IDT)
GB/T 23536-2009 Superabrasive - Types of synthetic diamond
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance (ISO 13402:1995, MOD)
YY/T 0752-2016 Electrical surgical equipment for osseous tissue
JB/T 7989-2012 Superabrasive - Technical condition of synthetic diamond
JB/T 11428-2013 Superabrasive products - Electroplated mounted points
Pharmacopoeia of the People's Republic of China (Edition 2015)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0752-2016 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
bur
cutting tools that are powered by electric osseous tissue surgical equipment to perform mechanical rotary motion for grinding resection on osseous tissue, typically consisting of cutting part, shaft, coupling, and (if applicable) mechanical protection 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 grinding resection on osseous tissue, typically consisting of cutting edge and/or abrasive particle coating
3.4
shaft
structural part that connects to the cutting part and co
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Requirements
6 Test methods
7 Instructions and labeling
YY/T 1629.1-2018 Cutting tools for electric osseous tissue surgical equipment - Part1: Burs
1 Scope
This part of YY/T 1629 specifies the terms and definitions, materials, requirements, test methods, instructions, and labeling for burs among cutting tools used in conjunction with electric osseous tissue surgical equipment.
This part is applicable to burs (hereinafter referred to as products) that are powered by electric osseous tissue surgical equipment to perform mechanical rotary motion for grinding resection on osseous tissue.
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 2411-2008 Plastics and ebonite - Determination of indentation hardness by means of a durometer (shore hardness) (ISO 868:2003, IDT)
GB/T 4340.1-2009 Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2005, MOD)
GB/T 6406-2016 Superabrasive - Checking the grain size
GB/T 6408-2003 Super abrasive - Cubic boron nitride
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 11336-2004 Measurement of departures from straightness
GB/T 14233.1-2008 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 (ISO 10993-1:2009, IDT)
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999, IDT)
GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2002, IDT)
GB/T 23536-2009 Superabrasive - Types of synthetic diamond
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance (ISO 13402:1995, MOD)
YY/T 0752-2016 Electrical surgical equipment for osseous tissue
JB/T 7989-2012 Superabrasive - Technical condition of synthetic diamond
JB/T 11428-2013 Superabrasive products - Electroplated mounted points
Pharmacopoeia of the People's Republic of China (Edition 2015)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0752-2016 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
bur
cutting tools that are powered by electric osseous tissue surgical equipment to perform mechanical rotary motion for grinding resection on osseous tissue, typically consisting of cutting part, shaft, coupling, and (if applicable) mechanical protection 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 grinding resection on osseous tissue, typically consisting of cutting edge and/or abrasive particle coating
3.4
shaft
structural part that connects to the cutting part and co
Contents of YY/T 1629.1-2018
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Requirements
6 Test methods
7 Instructions and labeling
