This Part of YY 0117 specifies the requirements, test methods, inspection rules, quality certification, marking and packaging of implants for surgery - forgings, castings for bone joint prostheses - ZTi6Al4V titanium alloy castings. This Part applies to the production and acceptance of ZTi6Al4V titanium alloy castings for bone joint prosthesis.
Basic Data
Standard ID
YY 0117.2-2005 (YY0117.2-2005)
Description (Translated English)
Implants for surgery. Forgings, castings for bone joint prostheses. ZTi6A14V titanium alloy castings
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C35
Classification of International Standard
11.040.40
Word Count Estimation
8,867
Date of Issue
2005-12-07
Date of Implementation
2006-12-01
Older Standard (superseded by this standard)
YY 0117.2-1993
Regulation (derived from)
Industry Standard Notice 2006 No. 2 (No. 74 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the use ZTi6A14V titanium alloy materials manufacturing surgical implants bone and joint prosthesis casting requirements, test methods, inspection rules, quality certification, marking and packaging. This standard applies to bone and joint prosthesis ZTi6A14V titanium castings and acceptance.
