Yonsei Med J.  1999 Dec;40(6):530-535. 10.3349/ymj.1999.40.6.530.

Preclinical evaluation of prototype products

• Park JC
• Lee DH
• Suh H

• KMID: 1726192
• DOI: http://doi.org/10.3349/ymj.1999.40.6.530

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.

Keyword

Preclinical evaluation; medical device; biomaterial; safety; biocompatibility

MeSH Terms

Animal
Carcinogenicity Tests
Equipment and Supplies*/adverse effects
Hemolysis
Human
Pyrogens/toxicity
Sterilization