Page 412 - Safety Risk Management for Medical Devices

REFERENCES

[1] Guide 51, Safety Aspects—Guidelines for Their Inclusion in Standards, third ed., 2014.
[2] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on
medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation
(EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
[3] ISO 14971:2007, Medical Devices Application of Risk Management to Medical Devices.
[4] Council Directive 93/42/EEC, Medical Device Directive (MDD).
[5] Official Journal of the European Union.
[6] Council Directive 90/385/EEC, Active Implantable Medical Device Directive (AIMDD).
[7] EN ISO 14971:2012, Medical Devices—Application of Risk Management to Medical Devices.
[8] IEC 60601-1, Edition 3.1 Medical Electrical Equipment Part 1: General Requirements for
Basic Safety and Essential Performance.
[9] IEC 62304:2015, Medical Device Software Software Life-Cycle Processes.
[10] P.L. Bernstein, Against the Gods: The Remarkable Story of Risk, Wiley, New York, 1998.
[11] A. Willet, The Economic Theory of Risk and Insurance, University of Pennsylvania Press,
Philadelphia, PA, 1901.
[12] N.G. Leveson, Engineering a Safer World, MIT Press, Cambridge, 2012.
[13] M. Lewis, The Undoing Project, Norton, New York, 2017.
[14] IEC 62366-1:2015, Medical Devices, Part 1: Application of Usability Engineering to Medical
Devices.
[15] ISO 10993-1 (2017), Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
Within a Risk Management Process.
[16] MAUDE Database, FDA Manufacturer and User Facility Device Experience.
[17] EUDAMED: European Database on Medical Devices.
[18] FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices,
February 3, 2016.
[19] IEC 60601-1-8:2006, Medical Electrical Equipment Part 1-8: General Requirements for Basic
Safety and Essential Performance Collateral Standard: General Requirements, Tests and Guidance
for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems.
[20] ANSI/AAMI HE 75:2009/ (R) 2013, Human Factors Engineering Design of Medical Devices.
[21] EN ISO 13485:2016, Medical Devices—Quality Management Systems—Requirements for
Regulatory Purposes.
[22] Notified Bodies Recommendation Group; Consensus Paper for the Interpretation and Application
of Annexes Z in EN ISO 14971: 2012; Version 1.1; 13 Oct. 2014.
[23] M. Bordwin, Factoring the Law into Medical Device Design, MDDI, March 2005.
[24] NASA Fault Tree Handbook with Aerospace Applications; Ver 1.1, August 2002.
[25] FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices, December 28,
2016.
[26] IEC TR 80002-1 Technical Report, Medical Device Software Part 1: Guidance on the
Application of ISO 14971 to Medical Device Software, Edition 1.0 2009-09.
[27] FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical
Devices, 2005.
[28] G.J. Holzmann, The Power of Ten Rules for Developing Safety Critical Code, IEEE Computer,
NASA/JPL Laboratory for Reliable Software, Pasadena, CA, June 2006, pp. 93 95.
[29] Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket
Approval and De Novo Classifications, FDA, March 28, 2012.
[30] Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket
Notifications [1510(k)] with Different Technological Characteristics, FDA, July 15, 2014.

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