无源外科植入医疗器械不锈钢材料研究进展及审评思考
Recent Advance of Stainless Steel Used In Non-active Surgical Implantable Medical Device and Regulatory Perspective
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摘要: 不锈钢材料广泛应用于心血管、骨科、齿科、眼科等无源外科植入医疗器械中,针对外科植入医疗器械不锈钢材料研发、相关标准的演化进行介绍,总结了新型不锈钢材料在外科植入医疗器械中的最新应用进展,并在此基础上提出了对于此类产品审评的建议和思考。Abstract: Stainless steel has been widely used in non-active surgical implantable medical device of cardiovascular, orthopedics, dental and ophthalmology. In this paper, we mainly focused on development of stainless steel, as well as the material-related standard evolution. We further summarized the recent advancement of stainless steel use in surgical implantable medical device. Insight and regulatory perspective has been further demonstrated.