The evaluation of test results is based on strict technical specifications. Regarding physical properties, the calibration error must not exceed ±5% of the nominal capacity; the piston sliding resistance should be within the specified range without any stalling; the needle puncture force must be below the limit to ensure injection comfort. Chemical properties require that the residual ethylene oxide content be less than 10 μg/g; the ultraviolet absorbance at the specified wavelength not exceed the limit; and the total heavy metal content comply with pharmacopoeia regulations.
Biological properties must pass all sterility tests, with bacterial endotoxin content below 20 EU/unit; cytotoxicity tests showing no cytotoxic reaction; and all biocompatibility test results must meet the standard requirements. Failure to meet any single indicator constitutes a failure of the entire batch of products, requiring investigation of the cause and corrective action. Only products that meet all standard requirements are approved for market release for clinical use.
