文章基本信息
- 标题：Risk management of medical devices – A new era for standardization
- 本地全文：下载
- 作者：Alfred M Dolan
- 期刊名称：ISO Focus
- 出版年度：2007
- 卷号：2007
- 期号：feb
- 出版社：International Organization for Standardization
- 摘要：The provision of safe and effective devices for patients and health care users is the basis for medical device standards and regulation the world over. To this end, work on the standard, ISO 14971:2000, Medical devices – application of risk management to medical devices, was initiated more than a decade ago.
