GB/T 16175-2008

Active

Biological evaluation test methods for medical organic silicon materials

医用有机硅材料生物学评价试验方法

Standard Type
GBT
ICS
11.100
CCS
C30
Status
Active
Issue Date
2008-01-22
Implementation
2008-09-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies biological evaluation test methods for medical organic silicon materials, including cytotoxicity, sensitization, irritation, and implantation tests. It is applied in the healthcare industry for quality control and safety assessment of silicone-based medical devices such as catheters, implants, and prosthetics. The standard ensures these materials meet biocompatibility requirements before clinical use or regulatory approval.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.