This Standard specifies the test method of bone implantation of dental medical devices. This Standard shall be used to evaluate the biological reactions of bone tissue of which the dental bone issue is planned to contact with dental medical devices in long-term.
Basic Data
Standard ID
YY/T 0127.4-2009 (YY/T0127.4-2009)
Description (Translated English)
Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C33
Classification of International Standard
11.060.10
Word Count Estimation
11,175
Date of Issue
2009-12-30
Date of Implementation
2011-06-01
Older Standard (superseded by this standard)
YY/T 0127.4-1998
Quoted Standard
GB/T 13810; GB/T 16886.6; GB/T 16886.12
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies test methods for oral bone implanted medical devices. This standard is used to evaluate the biological response of bone tissue for the proposed long-term oral bone tissue in contact with the oral medical devices.
