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PD IEC/TR 80001-2-2:2012

Действует
Application of risk management for IT-networks incorporating medical devices. Guidance for the disclosure and communication of medical device security needs, risks and controls — 56 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO/TR 27809:2007
Действует
Health informatics -- Measures for ensuring patient safety of health software — 46 стр.
BS ISO/IEC 27002:2013
Действует
Information technology. Security techniques. Code of practice for information security controls — 94 стр.
ISO 27799:2008
Заменен
Health informatics -- Information security management in health using ISO/IEC 27002 — 68 стр.
ISO/TS 25238:2007
Действует
Health informatics -- Classification of safety risks from health software — 34 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO/TS 13606-4:2009
Действует
Health informatics -- Electronic health record communication -- Part 4: Security — 52 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO/IEC 27005:2011
Заменен
Information technology -- Security techniques -- Information security risk management — 76 стр.
ISO/IEC 27002:2005
Действует
Information technology -- Security techniques -- Code of practice for information security management — 115 стр.
ISO/IEC 27001:2005
Действует
Information technology -- Security techniques -- Information security management systems -- Requirements — 34 стр.
ISO/IEC 20000-2:2012
Действует
Information technology -- Service management -- Part 2: Guidance on the application of service management systems — 94 стр.
ISO/IEC 20000-1:2011
Заменен
Information technology -- Service management -- Part 1: Service management system requirements — 36 стр.
BS ISO/IEC 15408-3:2008
Действует
Information technolgy. Security techniques. Evaluation criteria for IT security. Security assurance components — 188 стр.
IEC 62304:2006 ed1.0
Действует
Medical device software - Software life cycle processes — 78 стр.
IEC 61907:2009 ed1.0
Действует
Communication network dependability engineering — 126 стр.
IEC 60601-1-8:2006 ed2.0
Действует
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 — 157 стр.
IEC 60601-1-6:2006 ed2.0
Заменен
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability — 73 стр.
IEC 60300-3-9:1995 ed1.0
Заменен
Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems — 67 стр.
IEC 80001-1:2010 ed1.0
Заменен
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities — 86 стр.