ГОСТ Р 56850—2015
(1)IEC 60300-3-9:1995
(2)IEC 60601-1-6:2006
(3]IEC 60601-1-6:2006
(4]IEC 61907:2009
(51IEC 62304:2006
(6)IEC 80001-2-1
[7] ISO/IEC 15408
[8j ISO/IEC 20000-1:2011
[12] ISO 14971:2007
[13] ISO/TS 25238:2007
[141 ISO 27799:2008
[151 ISO/TR 27809:2007
[16] IEEE 610.12:1990
ASIP requirements
DICOM
Japan Law/Guidance
NEMA/COCIR/JIRA
Библиография
Dependability management — Part 3-9: Application guide — Risk analysis of technological
systems21
Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
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
Communication network dependability engineering
Medical device software — Software life cycle processes
Application of nsk management for IT-networks incorporating medical devices — Part 2-1:
Step by step risk management of medical IT-networks — Practical applications and
examples IEC 80001-2-3. Application of risk management for IT-networks incorporating
medical devices — Part 2-3: Guidance for wireless networks
Information technology — Security techniques — Evaluation criteria for IT security —
Parts 1. 2. and 3 [«Common Criteria»!
Information technology — Service management — Part 1: Service management system
requirements ISO/IEC 20000-2:2012. Information technology — Service management —
Part 2: Guidance on the application of service management systems
[91 ISO/IEC 27001:2005 Information technology — Security techniques — Information security management
systems — Requirements
[10] ISO/IEC 27002:2005 Information technology. Security techniques. Code of practice for information security
management ISO/IEC 27005:2011.Information technology — Security techniques —
Information security risk management
[111 ISO 13485:2003Quality management systems — Requirements for regulatory purposes ISO/TS
13606-4:2009. Health informatics — Electronic health record communication — Part 4:
Security
Medical devices — Application of risk management to medical devices
Health informatics — Classification of safety risks from health software
Health informatics — Information security management in health using ISO/IEC 27002
Health informatics — Measures for ensuring patient safety of health software
IEEE Standard Glossary of Software Engineering Terminology
FR I’Agence des Systemes d’lnformation Partagds de Sante (ASIP Sant6) (ASIP Santa, the
shared healthcare information systems agency
http://esante.gouv.fr/en]
creating conditions
to comply with La\v No. 2002-303 of 4 March 2002 on patients’ rights and quality care
system
Digital Imaging and Communications in Medicine (DICOM)
National Electrical Manufacturers Association.
http://medical.nema.org/dicom/
JP Act on the Protection of Personal Information (PFD)
http://www.caa.go.jp/seikatsu/kojirvind6x_en.html
and Guideline for Medical Information
System Safety Management
http://www.mhlw.go.jp/shingi/2010/02/s0202-4.html
(Japanese only). Ministry of Health,
Labour and Welfare. Japan
Joint Security and Privacy Committee. See tutorials and white
papers at
http://www.medicalimaging.org/policy-and-positions/jointsecurity-and-privacy-committee-Z’
2I Заменен на МЭК/VICO 310101:2009. Менеджмент риска. Методики оценки риска.
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