| Preclinical evaluation of prototype products. | |
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MedLine Citation:
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PMID: 10661028 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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J C Park; D H Lee; H Suh |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Yonsei medical journal Volume: 40 ISSN: 0513-5796 ISO Abbreviation: Yonsei Med. J. Publication Date: 1999 Dec |
Date Detail:
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Created Date: 2000-02-17 Completed Date: 2000-02-17 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 0414003 Medline TA: Yonsei Med J Country: KOREA (SOUTH) |
Other Details:
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Languages: eng Pagination: 530-5 Citation Subset: IM |
Affiliation:
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Department of Medical Engineering, Yonsei University College of Medicine, Seoul, Korea. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Carcinogenicity Tests Equipment and Supplies* / adverse effects Hemolysis Humans Pyrogens / toxicity Sterilization |
| Chemical | |
Reg. No./Substance:
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0/Pyrogens |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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