摘要
该文对负压引流装置产品注册产品分类现状和相关的医疗器械分类管理文件进行分析、研究。从预期用途、产品组成、作用原理、接触部位、是否有组分被人体吸收等因素,总结出一套负压引流装置产品分类界定规律。这有助于对负压引流装置产品做出更客观、更统一的风险分类。
The classification messages of non-powered suction apparatus device （NPSAD） intended for negative pressure wound therapy by CFDA have been analysis and generalized. A set of classification regular patterns of NPSAD have been generalized from its intended use, composition, mechanism, contact area and resorbable characteristic. It is helpful to draw a more consistent classification in NPSAD.
出处
《中国医疗器械杂志》
CAS
2015年第4期292-294,共3页
Chinese Journal of Medical Instrumentation
基金
中检院中青年基金(2013NC4)
关键词
负压引流装置
分类
规律
non-powered suction apparatus device intended for negative pressure wound therapy, classification, regular pattern
