[15] YY 0709-2009《医用电气设备 第1-8部分：安全通用要求并列标准医用电气设备和医用电气系统中报警系统的测试和指南》
[16] YY 0721-2009《医用电气设备放射治疗记录与验证系统的安全》
[17] YY 0775-2010《远距离放射治疗计划系统高能X(γ）射束剂量计算准确性要求和试验方法》
[18] YY 0831.1-2011《γ射束立体定向放射治疗系统第1部分：头部多源γ射束立体定向放射治疗系统》
[19] YY 0832.1-2011《X射线放射治疗立体定向及计划系统第1部分：头部X射线放射治疗立体定向及计划系统》
[20] YY/T 0287-2003《医疗器械质量管理体系法规要求》 [21] YY/T 0316-2008《医疗器械风险管理对医疗器械的应用》
[22] YY/T 0664-2008《医疗器械软件软件生存周期过程》 [23] YY/T 0708-2009《医用电气设备第1-4部分：安全通用要求并列标准可编程医用电气系统》
[24] YY/T 0887-2013《放射性粒籽植入治疗计划系统剂量计算要求和试验方法》
[25] YY/T 0889-2013《调强放射治疗计划系统性能和试验方法》
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[26] FDA, Do It by Design - An Introduction to Human Factors in Medical Devices, December, 1996
[27] FDA, Deciding When to Submit a 510(k) for a Change to an Existing Device, January 10, 1997
[28] FDA, Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software, January 13,1997
[29] FDA, Design Control Guidance for Medical Device Manufacturers, March 11, 1997
[30] FDA, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 29,1998
[31] FDA, Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9,1999
[32] FDA, Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, July 27, 2000
[33] FDA, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
[34] FDA, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, January 14, 2005
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[35] FDA, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
[36] FDA, Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision, December 11, 2008
[37] FDA, Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, July 3, 2012
[38] FDA, Guidance for Industry and FDA Staff - Clinical Performance
Assessment:
Considerations
for
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions, July 3, 2012
[39] FDA, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, October 2, 2014
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[40] FDA, Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff, February 9, 2015
[41] FDA, Medical Device Data Systems, Medical Image Storage Devices and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, February 9, 2015
[42] FDA, General Wellness: Policy for Low Risk Devices - Draft Guidance for Industry and Food and Drug Administration Staff, January 20, 2015
[43] MEDDEV 2.7/1 Rev.3, Clinical evaluation: Guide for manufacturers and notified bodies, December 2009
[44]
MEDDEV
2.7/4,
Guidelines
on
Clinical
investigations: a guide for manufacturers and notified bodies, December 2010
[45] MEDDEV 2.1/6, Qualification and Classification of standalone software, January 2012
[46] NB-MED/2.2/Rev4, Software and Medical Devices, March 29, 2010
[47] Team-NB, Frequently Asked Questions related to the Implementation of EN 62304:2006 with respect to MDD 93/42/EEC, April 5, 2013
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[48] IEC 62366 Ed1.1:2014, Medical devices - Application of usability engineering to medical devices
[49] IEC/TR 80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
[50] IEC80001-1:2010, Application of risk management for IT-networks incorporating medical devices - Part 1: Roles,responsibilities and activities
[51] IEC/TR 80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks – Practical applications and examples
[52] IEC/TR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
[53] IEC/TR 80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
[54] IEC/TR 80001-2-4:2012, Application of risk management for IT-networks incorporating medical devices -
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