In order to ensure the quality of medical devices and the safety and effectiveness of clinical medical use, biocompatible evaluations must be performed on non -active materials involved in the production process to monitor the process of production process and the release of final products. Therefore, the evaluation of biocompatibility is the theme of always penetrating the study of biomass materials, and it is also a issue that related product manufacturers must pay attention to. This article has compiled the relevant points in the evaluation of biological compatibility for your reference.

Evaluation criteria for biocompatibility

1. The characteristics of biological evaluation standards in ISO

(1) Clarify the classification of medical devices, and divide the contact site into three categories: surface contact, in vitro and in vivo, and in vivo implantation;

(2) In the contact time, the contacts of less than 24h are listed as a momentary contact. The short and medium -term contact time is greater than 24h to 30 days, and long -term contact for more than 30 days;

(3) Biological evaluation tests are divided into two categories: basic evaluation tests and supplementary evaluation tests. The sub -chronic and subacute toxicity tests are included in the basic evaluation test items and canceled the thermal original test project; in the supplementary evaluation test, the two items of reproduction and development toxicity and biodegradation test were added.

2. The difference between Chinese biology evaluation standards and international standards

(1) List thermal test as a biological evaluation test for basic evaluation;

(2) List the hemolysis test as a biological evaluation test;

(3) Including subacute (sub -chronic) toxicity tests in the supplementary evaluation section.

Trial characteristics

(1) Most and outer biological test testing solution for sample materials, use 121 ° C physiological saline 60min to test for testing;

(2) Plant into the body directly with materials and medical equipment, and test it with tissue, blood or body tissue, and blood contact;

(3) Most of the in vivo tests are performed through surgical operation methods;

(4) For in vitro cell culture, observe the cytotoxicity of the sample, determine the toxic effect of immersion liquid or material on cell dissolution (cell death), inhibit growth;

(5) The carcinogenic test is implanted in a certain part of the material of different shapes, sizes, and surface states to observe the entire life of the animal and medical equipment on the potential carcinogenic effect of the animal's life.

(6) Blood compatibility test is to directly contact the blood through materials and medical equipment. First, observe the coagulation effect on platelet activation and thrombosis.

(7) Incutation test is to bury biomass and medical equipment into some parts of the animal body, and observe the changes in local tissue pathology in different time materials;

(8) The degradation test adopts various internal and external methods to determine the degree of degradation of materials and medical devices and changes in mechanical strength, understand the absorption, distribution, metabolic process of degradation products in the body, and evaluate the harmful effect of materials on the body.