전과정 관점에서 생체재료의 발열성과 무균성 관리

Abstract

The proper sterilization methods for biomaterials as eradicating harmful microorganisms is very important safety element to prevent infections of patients before transplanting biomaterials. The sterilization process to eradicate microorganisms, which is a special process in a sense that the degree of sterilization cannot be fully verified, requires validation methods. Therefore, a comprehensive quality system is essential throughout the entire process, such as prevention of microorganism contamination, sterilization process and maintenance of sterility for the control of pyrogenicity and sterility. This paper describes (1) a method to control pyrogenicity of medical devices that contact with blood, such as artificial blood vessels, blood dialyzer and stent, provides (2) an understanding of the concept of sterilization validation as a means to demonstrate sterility assurance level (SAL) and reviews (3) the application techniques of sterilization validation method to achieve SAL of invasive medical devices in the perspective of life cycle, focusing on the half cycle method.