http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
김동빈,공석경,함중걸,이미희,유선국,박종철 한국생체재료학회 2011 생체재료학회지 Vol.15 No.1
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.
김동빈,공석경,유우진,이미희,유선국,박종철 한국생체재료학회 2012 생체재료학회지 Vol.16 No.1
The contamination of body contacting medical devices is the major hazard. As reusable medical devices (RMDs) are used repeatedly among many patients, especially, the problems of cross contamination due to the use of RMDs are being highlighted as a social issue at home and abroad. To solve this issue, active research and work is under progress including the issuance of new guidelines by competent governmental authorities such as the US Centers for Disease Control (CDC) and the US Food and Drug Administration (FDA). Although risk aspects of RMDs are significant such as cross contamination, the level of control systems and technologies to deal with it is relatively low. Therefore, it is necessary to introduce the scientific technical standards and management methodology for RMDs that consider the situation where they are repeatedly reused and reprocessed. This paper (1) analyzes the classification system of RMDs such as invasive critical devices(surgical instruments and laparoscopes, etc.), and mucous membrane or nonintact skin exposed semicritical devices(broncoscopes and aspirator tubes); (2) addresses the factors to be considered in the material selection and design of RMDs such as metals and polymers; (3) and suggests the validation and scientific evaluation methods of reprocessing for RMDs, focusing on cleaning.