摘要
目的对医用敷料分类界定规律进行了初步研究。方法分析了2007年以来国家食品药品监督管理总局发布的关于医用敷料分类界定信息,进行了归纳,总结出其中的规律并进行了验证。结果从产品的预期用途、产品组成、产品的作用原理、产品的作用部位、产品中是否有组分被人体吸收等方面,总结出一套医用敷料分类界定规律。并对这些规律进行了初步验证,发现只要了解具体产品的灭菌状态、使用部位的创伤程度、产品是否可被人体吸收等信息,将得到较高的符合率。结论本文所总结的医用敷料分类界定规律有相当的适用性,如果能被广泛采用,将有助于对医用敷料做出更客观、更统一的风险分类,为规范医用敷料的科学监管、促进医用敷料的产业发展奠定基础。
Objective To investigate the regular classification pattern of medical dressings.Methods The classification information for medical dressings issued by SFDA was analyzed and generalized,and the pattern of classification was summarized and verified.Results A set of regular classification patterns of medical dressings was summarized from aspects of intended use,composition,mechanism,contact area and absorbable characteristics of products.After a preliminary verification of the patterns,it was found that a relatively high accuracy would be obtained with provision of information such as sterilization status, trauma severity,absorbability and so on.Conclusion The regular classification pattern of medical dressings had considerable applicability.If this pattern could be applied widely,it would be helpful to draw a more consistent classification for medical dressings and establish a solid foundation for scientific regulation and industrial development of medical dressings.
出处
《中国药事》
CAS
2014年第9期1009-1013,共5页
Chinese Pharmaceutical Affairs
基金
中国食品药品检定研究院中青年基金(编号2013NC4)
关键词
医用敷料
分类
规律
medicaldressings
classification
regularpattern
