This standard specifies the definition, performance requirements, corresponding test methods of dental implants, which are made of titanium and titanium alloys without surface coating; specifies the contents of packaging and marking. Implant accessories are not covered by this standard. This standard is applicable to the dental implants, as made from the titanium and titanium alloy materials, whose chemical composition conforms to GB/T 13810-2007 "Wrought titanium and titanium alloy for surgical implants" or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67-00, ASTM F136-12a, ASTM F1295, ASTM F1472, for the purposes of surgical implants.
Basic Data
Standard ID
YY 0315-2016 (YY0315-2016)
Description (Translated English)
Wrought titanium and titanium dental implant
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the definition, performance requirements and corresponding test methods for dental implants made of titanium and titanium alloy without surface coating, and specifies the contents of packaging and labeling. This standard does not contain implant attachments. This standard applies to the chemical composition in accordance with GB/T 13810-2007 "artificial plant titanium and titanium alloy processing materials" or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67-00, ASTM F136- 12a, ASTM F1295, ASTM F1472 in the implantation of titanium and titanium alloy dental implant materials.
