Standard No.:	YY/T 1629.5-2020
English Name:	Cutting tools for electric osseous tissue surgical equipment—Part 5:Saw blade
Chinese Name:	电动骨组织手术设备刀具 第5部分：锯片
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2020-09-27
Implemented on:	2021-9-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	9500 words
Translation Price(USD):	285.0
Delivery:	via email in 1 business day

YY/T 1629.5-2020 Cutting tools for electric osseous tissue surgical equipment - Part 5: Saw blade 1 Scope This part of YY/T 1629 specifies the terms and definitions, structural types, materials, requirements, test methods, instructions and markings for saw blades among cutting tools for electric osseous tissue surgical equipment. This part is applicable to saw blades (hereinafter referred to as products) that are powered by electric osseous tissue surgical equipment to perform mechanical oscillating or reciprocating motion for sawing 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 1184 Geometrical tolerancing - Geometrical tolerance for features without individual tolerance indications 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 saw blade cutting tool that is powered by electric osseous tissue surgical equipment to perform mechanical oscillating or reciprocating motion for sawing osseous tissue, typically consisting of saw teeth, body, joint lever (if any), coupling, mechanical protection structure (if any) 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 saw teeth toothed portion used to provide the cutting edge 3.4 body structural part that connects the saw teeth to the joint lever (if any) or 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

Contents Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Structural types 5 Materials 6 Requirements 7 Test methods 8 Instructions and markings