ГОСТ Р МЭК 62366-1-2023. Национальный стандарт Российской Федерации. Изделия медицинские. Часть 1. Проектирование медицинских изделий с учетом эксплуатационной пригодности

[1]

IEC 60601-1:2005 <1>

IEC 60601-1:2005/AMD1:2012

IEC 60601-1:2005/AMD2:2020

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Изделия медицинские электрические. Часть 1. Общие требования безопасности с учетом основных функциональных характеристик)

[2]

IEC 60601-1-6:2010 <2>

IEC 60601-1-6:2010/Amd1:2013

IEC 60601-1-6:2010/AMD2:2020

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Изделия медицинские электрические. Часть 1-6. Общие требования безопасности с учетом основных функциональных характеристик. Дополнительный стандарт: Эксплуатационная пригодность)

[3]

IEC 60601-1-8:2006 <3>

IEC 60601-1-8:2006/AMD1:2012

IEC 60601-1-8:2006/AMD2:2020

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems (Изделия медицинские электрические. Часть 1-8. Общие требования безопасности с учетом основных функциональных характеристик. Дополнительный стандарт. Общие требования, испытания и руководство по системам тревожной сигнализации в электрической медицинской аппаратуре и системах)

[4]

IEC 60601-1-11:2015 <4>

IEC 60601-1-11:2015/AMD1:2020

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Изделия медицинские электрические. Часть 1-11. Общие требования безопасности с учетом основных функциональных характеристик. Дополнительный стандарт. Требования к медицинским электрическим изделиям и системам, используемым для медицинской помощи на дому)

[5]

IEC TR 61258:2008

Guidelines for the development and use of medical electrical equipment educational materials (Электроаппаратура медицинская. Руководство по разработке и использованию учебных пособий для обслуживающего персонала)

[6]

ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices (Руководство по разработке и включению аспектов безопасности в международные стандарты на медицинские изделия)

[7]

ISO 7010:2011

Graphical symbols - Safety colours and safety signs - Registered safety signs (Символы графические. Цвета и знаки безопасности. Зарегистрированные знаки безопасности)

[8]

ISO 9000:2015

Quality management systems - Fundamentals and vocabulary (Системы менеджмента качества. Основные положения и словарь)

[9]

ISO 9001:2015

Quality management systems - Requirements (Системы менеджмента качества. Требования)

[10]

ISO 9241-11:1998

Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (Эргономические требования, связанные с использованием видеотерминалов для учрежденческих работ. Часть 11. Руководство по определению и измерению используемости)

[11]

ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (Изделия медицинские. Системы менеджмента качества. Требования для целей регулирования)

[12]

ISO 16142-1:2016

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards (Изделия медицинские. Важнейшие принципы обеспечения безопасности и эксплуатационных характеристик медицинских изделий. Часть 1. Общие и дополнительные специфические важнейшие принципы для всех медицинских изделий, кроме изделий для диагностики in vitro, и руководство по выбору стандартов)

[13]

ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (Изделия медицинские. Руководство по применению ISO 14971)

[14]

ANSI/AAMI HE 74:2001

Human factors design process for medical device (Проектирование изделий медицинских с учетом человеческого фактора)

[15]

ANSI/AAMI HE 75:2009

Human factors engineering - Design of medical devices (Проектирование с учетом человеческого фактора. Конструкция изделий медицинских)

[16]

EN 1041:2008

Information supplied by the manufacturer of medical devices Amendment 1:2013 (Информация, подготавливаемая изготовителем, сопровождающая медицинские приборы. Изменение 1:2013)

[17]

GHTF SG2N31R8:2003, Global Harmonization Task Force (GHTF), Study Group 2 (SG2), Medical Device Post Market Vigilance and Surveillance: Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative

[18]

BEYER H., HOLTZBLATT K. Contextual Design: defining customer-centred systems. Morgan Kaufmann Publishers Inc, San Francisco CA, 1998

[19]

BROWN D. The challenges of user-based design in a medical device market. In D. Wixon and Ramey (Eds.), Field Methods Casebook for Software Design. New York: Wiley, 1996, pp. 157 - 176

[20]

CALLAN J.R., KELLY R.T., QUINN M.L., GWYNNE, J.W., MOORE R.A., MUCKLER F.A., KASUMOVIC J., SAUNDERS W.M., LEPAGE R.P., CHIN E., SCHOENFELD I., and SERIG D.I. (1995). Human factors evaluation of remote afterloading brachytherapy. (NUREG/CR-6125, Volumes 1 - 3) Washington, DC: U.S. Nuclear Regulatory Commission

[21]

COOKE N.J. Varieties of knowledge elicitation techniques. Int'l J Human-Computer Studies. 1994:41, pp. 801 - 849

[22]

DRURY C.G., PRABHU P., and GRAMOPADHYE A. Task analysis of aircraft inspection activities: Methods and findings. Proceedings of the Human Factors Society 34th Annual Meeting. Santa Monica, CA: Human Factors and Ergonomics Society. 1990, pp. 1181 - 1185

[23]

DUMAS J., and REDISH J. A Practical Guide to Usability Testing (Revised Edition), Exeter, UK, Intellect, 1999

[24]

ELLIS S.R., BEGAULT D.R., and WENZEL E.M. Virtual environments as human-computer interfaces. In M.G. Helander, T.K. Landauer, and P.V. PRABHU (Eds.), Handbook of human-computer interaction. Amsterdam: Elsevier. 1997, pp. 163 - 201

[25]

FLEISHMAN E.A., and QUAINTANCE M.K. Taxonomies of human performance: The description of human tasks. Orlando: Academic Press, 1984

[26]

GUNDRY J.W., COMESS K.A., Derook F.A., JORGENSON D., BRADY G.H. Comparison of sixth-grade children with trained professionals in the use of an automated external defibrillator. Circulation. 2000 Nov. 14; 102(20):E166

[27]

KIRWAN B., and AINSWORTH L.K. A Guide to Task Analysis. London, UK: Taylor & Francis, 1992

[28]

HOLTZBLATT K., and JONES S. Contextual inquiry: Principles and practice. In D. Schuler and A. Namioka (Eds.), Participatory Design: Principles and Practice. Hillsdale, NJ: Erlbaum (1993)

[29]

JONASSEN D.L., HANNUM W.H., and TESSMER M. Handbook of Task Analysis Procedures. Westport: Greenwood Publishing Group, 1989

[30]

KLEIN G.A., ORASANU J., CALDERWOOD R., and ZSAMBOK C.E. Decision Making in Action: Models and Methods. Norwood, New Jersey: Ablex Publishing Corp, 1993

[31]

LAUGHERY K.R.Sr., and LAUGHERY K.R.Jr. Analytic techniques for function analysis. In G. Salvendy (Ed.), Handbook of Human Factors. New York: Wiley, 1987, pp. 330 - 354

[32]

LOEB R., WEINGER M.B., and ENGLUND C.E. Ergonomics of the anesthesia workspace. Ehrenwerth, J. and Eisenkraft J.B., editors. Anesthesia Medical device: Principles and Applications. Mosby Year Book, Malvern, PA. 1993 pp. 385 - 404

[33]

MEISTER D. Behavioral Analysis and Measurement Methods. New York: John Wiley & Sons, 1985

[34]

NIELSEN J., Usability Engineering. San Diego: Academic Press, Inc, 1993

[35]

REASON J. Human Error. Cambridge, England: Cambridge University Press, 1990

[36]

REDMILL F. and RAJAN J. Human Factors in Safety-Critical Systems. Oxford: Butterworth-Heinemann, 1997

[37]

ROUSE W.B. Designing for human error: Concepts for error tolerant systems. In H.R. Booher (Ed.), MANPRINT: An approach to system integration. New York: Van Nostrand Reinhold, 1990

[38]

RUBIN J. Handbook of Usability Testing: How to Plan, Design, and Conduct Effective Tests, New York, NY, Wiley, 1994

[39]

SCHULER D. and NAMIOKA A. Participatory Design: Principles and Practices. HILLSDALE N.J.: Lawrence Erlbaum Associates, 1993

[40]

SHARIT J. Allocation of functions. In G. Salvendy (Ed.), Handbook of Human Factors and Ergonomics, 2nd edition, New York: Wiley, 1997, pp. 301 - 339

[41]

SINCLAIR M.A. Subjective assessment. In J.R. Wilson and E.N. Corlett (Eds.), Evaluation of human work. London: Taylor & Francis. 1990, pp. 58 - 88

[42]

WIENER E.L., and NAGEL D.C. (Eds.) Human factors in aviation. San Diego: Academic Press 1988

[43]

WEINGER M.B., HERNDON O.W., and GABA D.M. The effect of electronic record keeping and transesophageal echocardiography on task distribution, workload, and vigilance during cardiac anesthesia. Anesthesiology 1997, 87:144 - 155

[44]

WEINGER M., WIKLUND M. and GARDNER-BONNEAU D. A Handbook of Human Factors in Medical Device Design, Boca Raton, FL, CRC Press, 2011

[45]

WIKLUND M., KENDLER J., and STROCHLIC. Usability testing of Medical Devices, Boca Raton, FL, CRC Press, 2010

[46]

ZHANG J., PATEL V.L., JOHNSON T.R., CHUNG P., and TURLEY J.P. Evaluating and predicting patient safety for medical devices with integral information technology. In Advances in Patient Safety (vol. 2), Washington, DC: AHRQ. 2005, p. 323

[47]

ISO 16142-2:2017

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

[48]

US FDA, (2016)

Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016

[49]

US FDA, (2016)

Draft Guidance for Industry and FDA Staff: Combination Product Design and Development, February 2016

УДК 006.83:006.354

ОКС 11.040.01

Ключевые слова: медицинские изделия, проектирование и разработка, риск, эксплуатационная пригодность, человеческий фактор, пользовательский интерфейс