Baldrick Paul
Scientific and Regulatory Consultancy Group, Covance Laboratories Ltd, Harrogate HG3 1PY, UK.
Med Device Technol. 2003 Jun;14(5):12-5.
The extent of testing polymer-containing medical devices is subject to a range of considerations and needs to be determined on a case-by-case basis. This article reports on recent areas of concern for device materials including biodegradation and immunogenicity potential.
对含聚合物的医疗器械进行测试的程度需考虑一系列因素，且需逐案确定。本文报道了器械材料近期受到关注的领域，包括生物降解性和潜在免疫原性。
