This document specifies general requirements for the chemical and biological properties, sterility, packaging and marking of surgical implants made of silicone elastomer. This document is applicable to the test and evaluation of surgical implants made of silicone elastomer. NOTE 1.this document does not specify specific indicators of the physical and mechanical properties of the implants. NOTE 2.for surgical implants made of silicone elastomer that have added color masterbatch and developer, etc. in order to increase the functionality of the products, the manufacturer may refer to this document based on risk assessment.
Basic Data
Standard ID
YY/T 0334-2022 (YY/T0334-2022)
Description (Translated English)
General specification for surgical implants made of silicone elastomer
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
