ГОСТ Р МЭК 80001-1—2015
Библиография
[1 ]IEC 60601-1:2005. Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
[2] IEC 61907:2009, Communication network dependability engineering
[3] IEC 62304:2006. Medical device software — Software life-cycle processes
[4] ISO 14971:2007, Medical devices — Application of risk management to medical devices
[5] ISO/IEC 15026-2:2011, Systems and software engineering — Systems and software assurance — Part 2:
Assurance case
[6] ISO/IEC 15408 (all parts). Information technology — Security techniques — Evaluation criteria for IT security
[7] ISO 16484-2:2004. Building automation and control systems (BACS) — Part 2: Hardware
[8] ISO 9000:2005. Quality management systems — Fundamentals and vocabulary
[9] ISO/IEC 20000-1:2005, Information technology — Service management — Part ^Specification
[10] ISO/IEC 20000-2:2005. Information technology — Service management — Part 2: Code of practice
[11] ISO 31000:2009. Risk management — Principles and guidelines
[12] GHTF/SG1/N29R16:2005. Information Document Concerning the. Definition of the Term «Medical Device».
Global Harmonization Task Force (GHTF) — Study Group 1 (SG1)
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