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Preclinical evaluation of prototype products

Authors
 Jong Chul Park  ;  Dong Hee Lee  ;  Hwal Suh 
Citation
 Yonsei Medical Journal, Vol.40(6) : 530-535, 1999 
Journal Title
 Yonsei Medical Journal 
ISSN
 0513-5796 
Issue Date
1999
MeSH
Animals ; Carcinogenicity Tests ; Equipment and Supplies*/adverse effects ; Hemolysis ; Humans ; Pyrogens/toxicity ; Sterilization
Abstract
Preclinical evaluation of medical devices (prototype products) offers the opportunity to investigate and study the intended use of device materials. Preclinical evaluation programs are designed to determine the efficacy, safety, and biocompatibility of biomaterials, prostheses, and medical devices. The purpose of safety testing is to determine if a material presents potential harm to the human; it evaluates the interaction of the material with the in vivo environment and determines the effect of the host on the implant. Preclinical evaluation is the determination of the ability of the prototype product to perform with appropriate host response in a specific application, considered from the perspective of human clinical use. Therefore, preclinical data should include materials science and engineering, biology, biochemistry, medicine, host reactions and their evaluation, the testing of biomaterials, and the degradation of materials in a biological environment.
Files in This Item:
T199903541.pdf Download
DOI
10.3349/ymj.1999.40.6.530
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Medical Engineering (의학공학교실) > 1. Journal Papers
Yonsei Authors
Park, Jong Chul(박종철) ORCID logo https://orcid.org/0000-0003-0083-5991
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/174400
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