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医療機関等におけるサイバーセキュリティ対策の強化について（注意喚起）（令和４年11月10日） (69 ページ)
出典
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IMDRF/CYBER WG/N60FINAL:2020
13. ISO/TR 80001-2-7:2015, Application of risk management for IT-networks incorporating
medical devices – Application guidance – Part 2-7: Guidance for Healthcare Delivery
Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
14. ISO/IEC 27000 family - Information security management systems
15. ISO/IEC 27035-1:2016, Information technology – Security techniques – Information security
incident management – Part 1: Principles of incident management
16. ISO/IEC 27035-2:2016, Information technology – Security techniques – Information security
incident management – Part 2: Guidelines to plan and prepare for incident response
17. ISO/IEC 29147:2018, Information Technology – Security Techniques – Vulnerability
Disclosure
18. ISO/IEC 30111:2013, Information Technology – Security Techniques – Vulnerability
Handling Processes
19. ISO/TR 24971:2020, Medical devices – Guidance on the application of ISO 14971
20. UL 2900-1:2017, Standard for Software Cybersecurity for Network-Connectable Products,
Part 1: General Requirements
21. UL 2900-2-1:2017, Software Cybersecurity for Network-Connectable Products, Part 2-1:
Particular Requirements for Network Connectable Components of Healthcare and Wellness
Systems
7.3
規制当局のガイダンス
22. ANSM (Draft): Cybersecurity of medical devices integrating software during their life cycle
(July 2019)
23. China: Medical Device Network Security Registration on Technical Review Guidance
Principle (January 2017)
24. European Commission: 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 (May 2017)
25. European Commission: REGULATION (EU) 2017/746 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical
devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (May
2017)
26. FDA (Draft): Content of Premarket Submissions for Management of Cybersecurity in
Medical Devices (October 2018)
2020/3/18
Page 44 of 51
46／53 ページ
13. ISO/TR 80001-2-7:2015, Application of risk management for IT-networks incorporating
medical devices – Application guidance – Part 2-7: Guidance for Healthcare Delivery
Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
14. ISO/IEC 27000 family - Information security management systems
15. ISO/IEC 27035-1:2016, Information technology – Security techniques – Information security
incident management – Part 1: Principles of incident management
16. ISO/IEC 27035-2:2016, Information technology – Security techniques – Information security
incident management – Part 2: Guidelines to plan and prepare for incident response
17. ISO/IEC 29147:2018, Information Technology – Security Techniques – Vulnerability
Disclosure
18. ISO/IEC 30111:2013, Information Technology – Security Techniques – Vulnerability
Handling Processes
19. ISO/TR 24971:2020, Medical devices – Guidance on the application of ISO 14971
20. UL 2900-1:2017, Standard for Software Cybersecurity for Network-Connectable Products,
Part 1: General Requirements
21. UL 2900-2-1:2017, Software Cybersecurity for Network-Connectable Products, Part 2-1:
Particular Requirements for Network Connectable Components of Healthcare and Wellness
Systems
7.3
規制当局のガイダンス
22. ANSM (Draft): Cybersecurity of medical devices integrating software during their life cycle
(July 2019)
23. China: Medical Device Network Security Registration on Technical Review Guidance
Principle (January 2017)
24. European Commission: 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 (May 2017)
25. European Commission: REGULATION (EU) 2017/746 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical
devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (May
2017)
26. FDA (Draft): Content of Premarket Submissions for Management of Cybersecurity in
Medical Devices (October 2018)
2020/3/18
Page 44 of 51
46／53 ページ