1 Scope
This standard specifies the classification and nomenclature, requirements, test methods, inspection rules, marking, use instructions, packaging, transportation, storage and use requirements for metallic bone plates of implants for osteosynthesis.
This standard is applicable to implants for osteosynthesis - metallic bone plates (hereinafter referred to as simply bone plate) which are used for connecting the broken ends of fractured bone in orthopedic surgery. While, it does not cover specially designed bone plates.
2 Normative Reference
The following documents contain provisions which, through reference in this standard, 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 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 0342 Implants for Surgery - Determination of Bending Strength and Stiffness of Bone Plates (YY/T 0342-2002, ISO 9585:1990, IDT)
ISO 5832-2 Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium
ISO 5832-3 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium 6-aluminium 4-vanadium Alloy
3 Classification and Nomenclature
Foreword i
1 Scope
2 Normative Reference
3 Classification and Nomenclature
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
