This Part of YY/T 0988 includes stereological test methods for characterizing the coating thickness, porosity and average intercept of various porous coatings attached to non-porous substrates. Methods for measuring porosity and intercept at different levels of the "tissue interface gradient" in the various thicknesses of porous coatings are outlined in 9.4. The tangential sampling method in 8.2 is not applicable to the tissue interface gradient method in 9.4. This Part uses the International System of Units (SI). This Part does not attempt to describe all the security issues involved; even those security issues related to its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices, and to clarify the applicability of regulatory limitations prior to application.
Basic Data
Standard ID
YY/T 0988.14-2016 (YY/T0988.14-2016)
Description (Translated English)
Coatings of surgical implants - Part 14: Stereological evaluation method of porous coatings
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C35
Classification of International Standard
11.040.40
Word Count Estimation
15,151
Date of Issue
2016-03-23
Date of Implementation
2017-01-01
Regulation (derived from)
Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
