This document describes the bone implant test method for medical devices used in dentistry. This document is applicable to evaluating the biological response of tissues to dental medical devices intended for long-term or permanent contact with oral bone tissue.
Basic Data
Standard ID
YY/T 0127.4-2023 (YY/T0127.4-2023)
Description (Translated English)
Biological evaluation of medical devices used in dentistry - Part 4: 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
14,153
Date of Issue
2023-11-22
Date of Implementation
2024-12-01
Older Standard (superseded by this standard)
YY/T 0127.4-2009
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the bone implant test method for oral medical devices. This standard is applicable to the evaluation of biological responses of tissues to oral medical devices intended to be in long-term or persistent contact with oral bone tissue.
