This Standard specifies the terms and definitions, classification, requirements, test methods, manufacture, sterilization, packaging and information supplied by manufacturer of implants for osteosynthesis - metallic bone screws.
This Standard applies to metallic bone screws (hereinafter referred to as "bone screws"), which is used for internal fracture fixation in case of orthopedic surgery, excluding spine and specially designed bone screws.
2 Normative References
The following documents for the application of this Document are essential. For dated reference, only the edition cited applies. For undated reference, the latest edition of the normative document (including any amendments) applies.
GB 4234 Stainless Steel for Surgical Implants
GB/T 4340.1 Metallic Materials - Vickers Hardness - Part 1: Test Method
GB/T 10610 Geometrical Product Specifications (GPS) - Surface Texture: Profile Method - Rules and Procedures for the Assessment of Surface Texture
GB/T 13810 Wrought Titanium and Titanium Alloy for Surgical Implants
GB/T 16886.5 Biological Evaluation of Medical Devices - Part 5: Test for in Vitro Cytotoxicity
GB 23102 Implants for surgery - Metallic Materials - Wrought Titanium -6Aluminium-7Niobium Alloy
YY/T 1074 Implants for Surgery - Measuring Method for Pitting Corrosion Potential on Stainless Products
YY 0341 General Technological Requirements for Non - Active Metallic Surgical Implants for Osteosynthesis
YY/T 0343 Liquid Penetrant Inspection of Metallic Surgical Implants
YY 0605.9 Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
YY/T 0640 Non-active Surgical Implants - General Requirements
YY/T 0662 Implants for Surgery - Metal Bone Screws with Asymmetrical Thread and Spherical Under-surface - Mechanical Requirements and Test Methods
YY/T 1504 Implants for Surgery - Metallic Bone Screws - Axial Pull-out Force Test Methods
YY/T 1505 Implants for Surgery - Metallic Bone Screws - Self-tapping Performance Test Methods
YY/T 1506 Implants for Surgery - Metallic Bone Screws - Rotary Torque Test Methods
ISO 5835 Implants for surgery - Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-Surface of Head, Asymmetrical Thread - Dimensions
ISO 9268 Implants for surgery - Metal bone Screws with Conical Under-Surface of Head - Dimensions
3 Terms and Definitions
For the purpose of this document, the following terms and definitions apply.
3.1
Screw thread
Spiral groove on the surface of cylinder or cone. Protruding screw-type ridge is referred to as thread including crest and bottom.
