1 Scope
This standard specifies the classification, requirements, test methods, inspection rules, use instructions, marking, packaging, transportation and storage as well as use requirements of implants for osteosynthesis - metallic bone screws.
This standard is applicable to metallic bone screws (hereinafter referred to as bone screws) which are used for the internal fracture fixation in orthopedic surgery. While, it does not cover bone screw for spine and specially designed bone screw.
2 Normative References
The following documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding any corrigendum), or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For any undated references, the latest edition of the document referred to applies.
GB 4234 Stainless Steel for Surgical Implants (GB 4234-2003, ISO 5832-1:1997, MOD)
GB/T 4340.1 Metallic Materials - Vickers Hardness Test - Part 1: Test Method (GB/T 4340.1-1999, eqv ISO 6507-1:1997)
YY 0341 General Technological Requirements for Non-active Metallic Surgery Implants of Osteosynthesis
YY/T 0343 Liquid Penetrant Inspection of Metallic Surgical Implants (YY/T 0343-2002, ISO 9583:1990, NEQ)
ISO 5832-3 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium 6-aluminium 4-vanadium Alloy
ISO 5835 Implants for Surgery - Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-surface of Head, Asymmetrical Thread - Dimensions
ISO 6475 Implants for Surgery - Metal Bone Screws with Asymmetrical Thread and Spherical Under-surface - Mechanical Requirements and Test Methods
ISO 9268 Implants for Surgery - Metal Bone Screws with Conical Under-surface of Head - Dimensions
Foreword i
1 Scope
2 Normative References
3 Classification
4 Requirements
5 Test Methods
6 Inspection Rules
7 Use Instructions
8 Marking
9 Packaging
10 Transportation and Storage
11 Use Requirements
Appendix A (Informative) Schedule of Confirmed Method Standards for Chemical Analysis
