GB/T 41309-2022

Active

Nanotechnologies—Endotoxin test on nanomaterial samples for in vitro systems—Limulus amebocyte lysate (LAL) test

纳米技术 纳米材料的内毒素体外测试 鲎试剂法

Standard Type
GBT
ICS
07.030
CCS
C04
Status
Active
Issue Date
2022-03-09
Implementation
2022-10-01
Centralized Committee
中国科学院
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the use of the Limulus amebocyte lysate (LAL) test for detecting endotoxin contamination in nanomaterial samples intended for in vitro biological systems. It is applied in research, quality control, and safety evaluation of nanomaterials used in medical devices, pharmaceuticals, or cosmetics to ensure they do not trigger inflammatory responses in cell-based assays. The standard addresses the unique challenges of nanoparticle interference with the LAL test, providing validated protocols for accurate endotoxin measurement in these complex materials.

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.