1 Scope
This part of YY 0117 specifies the requirements, test methods, inspection rules, quality certificates, marking and packaging for the manufacture of implants for surgery - forgings for bone joint prostheses by Ti6A14V titanium alloy.
This part is applicable to the production and acceptance of titanium joint forgings for bone joint prostheses Ti6A14V.
2 Normative References
The following normative documents contain provisions which, through reference of YY 0117, constitute provisions of this part. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest editions apply to this part.
GB/T 228 Metallic Materials - Tensile Testing at Ambient Temperature (GB/T 228-2002, eqv ISO 6892:1998)
GB/T 231 Metallic Materials - Brinell Hardness Test - Part 1: Test Method (GB/T 231.1-2002, eqv ISO 6506-1:1999)
GB/T 4698 Methods for Chemical Analysis of Titanium and Titanium Alloys
GB/T 5168 Microstructure and Macrostructure Examination for α-β Titanium Alloys
GB/T 13810 Wrought Titanium and Titanium Alloy for Surgical Implants
YY 0341 General Technological Requirements for Non-active Metallic Surgery Implants of Osteosynthesis
ISO 5832-3:1996 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy
Foreword i
1 Scope
2 Normative References
3 Requirements
4 Test Methods
5 Inspection Rules
6 Quality Certificate
7 Marking, Packaging, Transportation and Storage