This part of YY/T 0127 specifies the oral mucous irritation test method for medical devices. This part is intended to evaluate the irritating effects onto the oral mucosal tissue of short-term, long-term and long-lasting oral medical devices that are in contact with oral mucosal tissue or other medical devices that are in contact with oral mucosal tissue.
Basic Data
Standard ID
YY/T 0127.13-2018 (YY/T0127.13-2018)
Description (Translated English)
Biological evaluation of medical devices used in dentistry - Part 13: Oral mucous irritation test
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C33
Word Count Estimation
10,111
Date of Issue
2018-04-11
Date of Implementation
2019-05-01
Older Standard (superseded by this standard)
YY/T 0127.13-2009
Regulation (derived from)
China Drug Administration Announcement No. 4 of 2018
