1 Scope
This Standard specifies relevant terms and definitions, requirements, test methods, manufacture, sterilization, packaging and information supplied by manufacturer of the implants for osteosynthesis - metallic bone plates (hereafter referred to as "bone plate").
This Standard is applicable to the bone plates for union with the broken ends of fractured bone during orthopedic surgery. This Standard is not applicable to all the types of bone plates, and the user shall investigate the applicability of this Standard in combination with specific types and intended uses of the bone plates and specify corresponding product performance requirements.
Neither is this Standard applicable to craniofacial-maxillofacial bone plates, angle fixers and spine fixation plates etc., nor does it contain description and requirements of the bone plates in the special design.
2 Normative References
The following documents for the application of this document are essential. Any 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 Test - 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 0018 Implants for Osteosynthesis - Metallic Bone Screws
YY/T 1074 Implants for Surgery - Measuring Method for Pitting Corrosion Potential on Stainless Products
YY/T 0342 Implants for Surgery - Determination of Bending Strength and Stiffness of Bone Plates
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 1503 Surgical Implants for Metal Plate Bending Fatigue Test Method
ISO 5836 Implants for Surgery - Metal Bone Plates - Holes Corresponding to Screws with Asymmetrical Thread and Spherical Under-Surface
ISO 9269 Implants for Surgery - Metal Bone Plates - Holes and Slots Corresponding to Screws with Conical Under-surface
3 Terms and Definitions
For the purposes of this document, terms and definitions established in YY/T 1503 and the following ones apply.
3.1
Non-active surgical implant for osteosynthesis
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Methods
6 Manufacture
7 Sterilization
8 Packaging
9 Information Supplied by Manufacturer
Appendix A (Informative) Typical Types of Metallic Bone Plates
Appendix B (Normative) Holes and Slots for Bone Plates in Accordance with ISO 5836 and ISO 9269
Appendix C (Informative) List of Approved Method Standards for Chemical Analysis
Bibliography
