골이식재 분해산물 확인 및 정량 시험의 의료기기 GLP 적용

Abstract

Biocompatibility testing of bone graft materials are important aspect for development of the device as well as the approval and certification by each individual country’s regulatory authority. Recently, importance in identification and quantification of degradation product as well as application of Good Laboratory Practice (GLP) in the process of biocompatibility testing has been emphasized. Hence, here identification and quantification of degradation products from bone graft materials were carried out in accordance with GLP process. Commercially available bone graft material from the animal source was used in this study. The test was carried out in accordance with International Standard, ISO 10993-14 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics. Also, entire process followed Institute for Management of Good Laboratory Practice, published by Ministry of Food and Drug Safety, Korea. Degradation test of the bone graft materials resulted in degradation of bone graft, ranging between 0.32 g to 0.86 g, while Ca and P were detected. In terms of GLP process, it has been noted that consideration of other International Standard such as ISO 10993-12 is required for planning of the GLP test, especially during the sample preparation.