This part of YY 0341 specifies the special requirements for non-active surgical implants for osteosynthesis (hereinafter referred to as "osteosynthesis implants"), including the terms and definitions, requirements, test methods, manufacturing, sterilization, packaging and information provided by the manufacturer, etc. of osteosynthesis implants. This part of YY0341 applies to osteosynthesis implants, not to the coating part of osteosynthesis implants with surface coating.
Basic Data
Standard ID
YY 0341.1-2020 (YY0341.1-2020)
Description (Translated English)
Non-active surgical implants - Osteosynthesis and spinal implants - Part 1: Particular requirements for osteosynthesis implants
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C35
Classification of International Standard
11.040.40
Word Count Estimation
14,166
Date of Issue
2020-09-27
Date of Implementation
2022-06-01
Older Standard (superseded by this standard)
YY 0341-2009
Regulation (derived from)
Announcement No. 108 (2020) of the National Medical Products Administration
