中国标准化Issue(3)：257-259,3.DOI:10.3969/j.issn.1002-5944.2025.03.045
医疗器械FDA-ASCA政策与程序研究
FDA-ASCA Policies and Procedures for Medical Devices
张泽楷 1杜晟威 2王丽洁 2张宏辉1
作者信息
- 1. 上海九维中博质量技术服务有限公司
- 2. 苏州苏大卫生与环境技术研究所有限公司
- 折叠
摘要
Abstract
Introduces regulatory background and application of FDA-ASCA,analyzes basic process,purpose,policies,application process,regulatory mode of ASCA.Conclusion:medical device stakeholders can have a clear understanding of ASCA policies and procedures,which is also beneficial for improving laboratory management,provides a reference regulatory model.关键词
FDA-ASCA/符合性声明/ASCA总结测试报告/GLPKey words
FDA-ASCA/declaration of conformity/ASCA summary test report/GLP引用本文复制引用
张泽楷,杜晟威,王丽洁,张宏辉..医疗器械FDA-ASCA政策与程序研究[J].中国标准化,2025,(3):257-259,3.
