YY 0315-2023: Wrought titanium and titanium alloy dental implant

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Scope

This Document specifies the performance requirements, packaging, labeling, and instructions
for use of uncoated dental implants made of wrought titanium and titanium alloys; and describes
the corresponding test methods.
This Document applies to dental implants made of titanium and titanium alloys with chemical
compositions conforming to GB/T 13810, ISO 5832-2, ISO 5832-3, ISO 5832-11, or ASTM
F67, ASTM F136, ASTM F1295, and ASTM F1472 for surgical implants.
This Document does not apply to dental implant accessories and additively manufactured
titanium and titanium alloy dental implants.

Basic Data

Standard ID	YY 0315-2023 (YY0315-2023)
Description (Translated English)	Wrought titanium and titanium alloy dental implant
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C33
Classification of International Standard	11.060.10
Word Count Estimation	14,144
Date of Issue	2023-11-22
Date of Implementation	2026-12-01
Older Standard (superseded by this standard)	YY 0315-2016
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the performance requirements, packaging, labeling and instructions for use of dental implants without surface coating made of forged titanium and titanium alloy materials, and describes the corresponding test methods. This standard applies to titanium and titanium alloy materials for surgical implants whose chemical composition complies with GB/T 13810 or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67, ASTM F136, ASTM F1295, ASTM F1472 Made dental implants. This standard does not apply to dental implant accessories and additively manufactured titanium and titanium alloy dental implants.