Medical device risk management and safety cases

被引：1

作者：

Jones, Paul L. ^{[1
]}

Taylor, Al ^{[2
]}

机构：

[1] Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD

[2] Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD

来源：

关键词：

Compendex;

D O I：

10.2345/0899-8205-49.s1.45

中图分类号：

学科分类号：

摘要：

[No abstract available]

引用

页码：45 / 53

页数：8

共 15 条

[1] McGowan R., Stevens A., Chapman R., Food and Drug Administration Review of Safety Assurance Cases for Medical Devices, J Clin Eng, 39, 2, pp. 96-98, (2014)
[2] Association for the Advancement of Medical Instrumentation, ANSI/AAMI/ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices, (2007)
[3] International Standards Organization, ISO/IEC TR15026-1:2010, Systems and Software Engineering - Systems and Software Assurance - Part 1: Concepts and Vocabulary, (2014)
[4] International Electrotechnical Commission, ISO 15026-2:2012, Systems and Software Engineering - Systems and Software Assurance - Part 2: Assurance Case, (2012)
[5] International Electrotechnical Commission, ISO 15026-4:2012, Systems and Software Engineering - Systems and Software Assurance - Part 4: Assurance in the Life Cycle, (2012)
[6] Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
[7] International Electrotechnical Commission, Ed., (2006)
[8] International Electrotechnical Commission, Ed., (2006)
[9] International Electrotechnical Commission, Ed., (2001)
[10] International Electrotechnical Commission, Ed., (2010)