摘要
目的为完善医疗器械产品标准档案工作提供参考。方法对医疗器械标准从收集、建立到保管等档案管理工作提出了实际操作方法和建议。结果与结论医疗器械监管工作已步入科学、有序的轨道。医疗器械标准及其档案的建立是医疗器械监管工作的一部分。
Objective The supervision work of medical device has entered the scientific and orderly track. Methods The establishment of standard file of medical device is a part of supervision work. Results and Conclusions To the medical device standard from the collection and establishment to records management work and so on the storage were proposed the actual operation method and the suggestion.
出处
《中国药事》
CAS
2009年第8期780-782,共3页
Chinese Pharmaceutical Affairs
关键词
医疗器械
标准
档案
medical device
standard file
establishment
