LAL test (Limulus Amebocyte Lysate)
1. Biological Effect: Material mediated pyrogenicity
2. Turnaround time: 4 weeks
3. Sample Requirements:
12 cm² (test item < 0.5 mm thick);
6 cm² (test item ≥ 0.5 mm thick);
at least 1 item;
Medical device is extracted in Water for injection according to ISO 10993-12. The extract’s content of bacterial endotoxin is measured by the chromogenic reaction of the LAL reagent and chromogenic substrate. Quantitative result is accompanied with product-specific validation.