ГОСТ IEC 62304—2022
[16] ISO/IEC Guide 51:2014
Safety aspects — Guidelines for their inclusion in standards (Аспекты безопас
ности. Руководящие указания по включению их в стандарты)
[17] IEEE 610.12:1990
IEEE standard glossary of software engineering terminology
[18] IEEE 1044:2009
IEEE standard classification for software anomalies
[19] U.S. Department Of Health and Human Services, Food and Drug Administration, Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices, May 11,2005, <:/
/www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/
ucm089543.htm>
[20] U.S. Department Of Health and Human Services, Food and Drug Administration, General Principles of Software
Validation: Final Guidance for Industry and FDA Staff, January 11, 2002,
<http://www.fda.gov/downloads/
Regulatorylnformation/Guidances/ucm126955.pdf>
[21] IEC 62366-1:2015
Medical devices — Part 1: Application of usability engineering to medical devices
(Изделия медицинские. Часть 1. Проектирование медицинских изделий с уче
том эксплуатационной пригодности)
[22] 82304-1:—3
Healthcare Software Systems — Part 1: General requirements (Изделия меди
цинские. Часть 1. Проектирование медицинских изделий с учетом эксплуата
ционной пригодности)
3 В стадии разработки.
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