GB/T 11417.8-2023

Active

Ophthalmic optics—Contact lenses—Part 8:Determination of shelf-life

眼科光学 接触镜 第8部分:有效期的确定

Standard Type
GBT
ICS
11.040.70
CCS
C40
Status
Active
Issue Date
2023-09-07
Implementation
2024-10-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the methods and criteria for determining the shelf life of contact lenses, including both hydrogel and silicone hydrogel types. It is applied by manufacturers and testing laboratories in the ophthalmic optics industry to validate product stability, sterility, and performance over time under specified storage conditions. The standard ensures that expiration dates assigned to contact lens products are scientifically justified and compliant with regulatory requirements for medical devices.

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.