ГОСТ Р 56840—2015
Библиография
П р и м е ч а н и е — Объединенная рабочая группа не подтверждает содержание каких-либо техниче
ских справочных документов, перечисленных ниже. Они предлагаются в качестве дополнительной информации,
связанной с руководством по применению требований стандарта МЭК 80001-1 к беспроводной МЕДИЦИНСКОЙ
ИТ СЕТИ.
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
Application of risk management for IT-networks incorporating medical devices —
Part 2-2. Guidance for the communication of medical device security needs, risks and
controls
Medical devices — Application of risk management to medical devices
Information technology — Security techniques — Evaluation criteria for IT security —
Part 2: Security functional components
Information technology — Security techniques — Information security management
systems — Requirements
Information technology — Security techniques — Code of practice for information
security management
Guidance on electromagnetic compatibility of medical devices for dinical/biomedical
engineers — Part 1: Radiated radio-frequency electromagnetic energy. Association for
the Advancement of Medical Instrumentation. 1110 N. Glebe Road. Suite 220. Arlington.
VA 22201-5762
Recommended Practice for an On-Site. Ad Hoc Test Method for Estimating Radiated
Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters,
American National Standards Institute/ The Institute of Electrical and Electronics
Engineers. Inc., 345 East 47th Street. New York. NY 10017-2394. USA
IEEE Recommended Practice for an Electromagnetic Site Survey (10 kHz to 10 GHz).
The Institute of Electrical and Electronics Engineers. Inc.. 345 East 47th Street. New
York. NY 10017-2394. USA
[10] IEEE Std 11073-00101-2008 Healthcare informatics — PoC medical device communication: Part 00101: Guide-
Guidelines for the use of RF wireless technology. The Institute of Electrical and
Electronics Engineers. Inc.. 345 East 47th Street. New York. NY 10017-2394. USA
[11] FDA Guidance Document: Draft Guidance for Industry and FDA Staff — Radio-Frequency Wireless
Technology in Medical Devices [cited 2012-06-08]. Available from Internet:
http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocumentS’,ucm077210.htm
[12] Failure mode and effects analysis in health care: proactive risk reduction. Chicago (IL): Joint Commission Resources.
Inc.; 2002. p.8
[13] Alarm Interventions During Medical Telemetry Monitoring: A Failure Mode and Effects Analysis. Pennsylvania
Patient Safety Authority [cited 2012-06-08]. Available from lntemet:
http://patientsafetyauthority.org/ADVISORIES/
AdvisoryLibrary/2008/mar5(suppl _rev)/Pages/mar5(supplrev).aspx
[14] Patient Safety: Achieving a New Standard for Care. Institute of Medicine. Washington D.C.: The National Academies
Press 2004
[15] The Quality System Compendium. GMP Requirements & Industry Practice. Association for the Advancement of
Medical Instrumentation. 1998.
[16] United States Code of Federal Regulations § 820
[17] ITU-T: An overview of the impairments and quality attributes of wireless applications [cited 2012-06-08]. Available from
Internet :
http://www.itu.mt/rec/T-REC/
[18] BAKER. Steven D. and Hoglund. David H. Medical-Grade. Mission-Critical Wireless Networks. IEEE Engineering in
Medicine and Biology Magazine. March/Apnl 2008. pp 86—95
[19] FDA Guidance for Industry — Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
[cited 2012-06-08]. Available from Internet:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments.’ucm077812.htm)
[20] ISO/IEC Joint Technical Committee — Health informatics — Use of mobile wireless communication and computing
technology in healthcare facilities
[1] IEC 80001-2-1:2012
[2] IEC 80001-2-2:2012
[3] ISO 14971:2007
[4] ISO/IEC 15408-2:2008
[5] ISO/IEC 27001:2005
[6] ISO/IEC 27002:2005
[7] AAMITIR-18
[8] ANSI C63.18
[9] IEEE Std 473-1985
37