This Part of YY 0341 specifies the special requirements for non-active surgical spinal implants (hereinafter referred to as "spinal implants"). In addition to the requirements that are specified in YY/T 0640, it also specifies the definition, requirements, test methods, manufacturing, sterilization, packaging and information provided by the manufacturer of spinal implants. This Part of YY 0341 applies to non-active surgical spinal implants other than artificial intervertebral disc implants.
Basic Data
Standard ID
YY 0341.2-2020 (YY0341.2-2020)
Description (Translated English)
Non-active surgical implants - Osteosynthesis and spinal implants - Part 2: Particular requirements for spinal implants
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C35
Classification of International Standard
11.040.40
Word Count Estimation
12,185
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Older Standard (superseded by this standard)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
