| Test item | Current standard | Purpose and method | Judgement criterion |
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Blood system | Coagulation | GB/ T16886.4—2003 | The devices/materials are directly contacted with venous blood and poor platelet plasma (usually rabbits), respectively, and the clotting time is measured to evaluate whether the sample contains endogenous coagulation system activators | Specify the acceptable criteria of the device/material on a verifiable basis (eg, compared to an approved device of the same type) | Platelet adhesion | The device/material is co-cultured with fresh sodium citrate anticoagulated whole blood (human, sheep or rabbit, etc.). The platelet adhesion on the surface of sample is observed to evaluate the effect of the sample on platelet performance | Thrombosis | The device/material is implanted into the vein. Thrombus formation on the surface of the sample and the intima surface of the blood vessel are observed and scored to evaluate the potential of forming thrombosis | Complement system | The device/material is contacted with human serum, and the concentration of C3a fragment formed during complement system activation is assessed by enzyme-linked immunosorbent assay to evaluate the effect of the sample on complement activation | Reproductive system | Reproductive toxicity | GB/ T16886.3—2019 | 8-10 weeks before mating, male and female animals (mouse) are continuously exposed to device/material or extracts until 21 d after the birth of F1 generation. The sexual function, estrus cycle, mating behavior, conception, parturition, lactation, and weaning of animals as well as the growth, development, deformity, morbidity and mortality of offspring are observed and recorded, to evaluate the influence of the sample on the reproductive function and embryonic development | There should be no significant difference compared to the negative control | Metabolic system | Toxicokinetics | GB/T16886.16—2021 | To study the quantitative changes in the process of absorption, distribution, metabolism and excretion of the test substance in the body, degradation products, leachables, and metabolites of device/material should be qualitatively detected and quantitatively analyzed. Rodent models (rats, mice) are generally used. Blood, urine, feces and bile are collected regularly after exposure, and the heart, liver, spleen, stomach, kidney, gastrointestinal tract, gonads, brain, body fat, skeletal muscle and other tissues are collected, respectively, to determine the distribution of the test substance. Bioavailability, toxicity-time curve, apparent volume of distribution, clearance rate, half-life, average residence time, maximum and maximum concentration (time) of the test substance were measured through the toxicokinetic model | The mathematical model expression of metabolic process, combing with the physical and chemical shape, administration route, dose and method of the test substance is evaluated comprehensively |
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