ГОСТ IEC 60601-1-8-2022. Межгосударственный стандарт. Изделия медицинские электрические. Часть 1-8. Общие требования безопасности с учетом основных функциональных характеристик. Дополнительный стандарт. Общие требования, испытания и руководящие указания по применению систем сигнализации медицинских электрических изделий и медицинских электрических систем

[1]

ISO 11428:1996

Ergonomics - Visual danger signals - General requirements, design and testing

[2]

ISO 11429:1996

Ergonomics - System of auditory and visual danger and information signals

[3]

ISO 14971:2000

Medical devices - Risk management - Application of risk management to medical devices

[4]

IEC 60513:1994

Fundamental aspects of safety standards for medical electrical equipment

[5]

AAMI EC57-293

Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

[6]

ANSI/AAMI HE48-1993

Human factors engineering guidelines and preferred practices for the design of medical devices

[7]

Block F.E. Jr., Rouse J.D., Hakala M., Thompson C.L. A proposed new set of alarm sounds which satisfy standards and rationale to encode source information. J Clin Monit Comput, 2000, 16, p. 541 - 546

[8]

Block F.E. Jr., Schaaf C. Auditory alarms during anesthesia monitoring with an integrated monitoring system. Intl J Clin Monit Comput, 1996, 13, p. 81 - 84

[9]

Block F.E. Jr. Human factors and alarms. Chapter 2 In Lake CL., ed. Clinical Monitoring for Anesthesia & Intensive Care. Philadelphia, WB Saunders, 1994, p. 11 - 34

[10]

Block F.E. Jr., Nuutinen L., Baallast B. Optimization of alarms: A study on alarm limits, alarm sounds, and false alarms, intended to reduce annoyance. J Clin Monit Comput, 1999, 15, p. 75 - 83

[11]

Edworthy J. Urgency mapping in auditory warning signals. In Stanton N., editor: Human Factors in alarm design. London: Taylor and Francis, 1994

[12]

Hedley-Whyte J., ed. Operating Room and Intensive Care Alarms and Information Transfer, ASTM Special Technical Publication STP 1152, Philadelphia 1992, ASTM

[13]

Kestin I.G., Miller B.R., Lockhart C.H. Auditory alarms during anesthesia monitoring. Anesthesiology, July, 1988, 69:1

[14]

Lawless S.T. Crying Wolf: False alarms in a pediatric intensive care unit. Crit Care Med, 1994, 22, p. 981 - 985

[15]

Momtahan K., Hetu R., Tansley B. Audibility and identification of auditory alarms in the operating room and intensive care unit. Ergonomics, 1993, 36, p. 1159 - 1176

[16]

O'Carroll T.M. Survey of alarms in an intensive care unit. Anesthesia, 1986, 41, p. 742 - 744

[17]

Optom Vis Sci, Dec. 2002, 79(12), p. 788 - 92

[18]

Patterson R.D., Edworthy J., Shailer M.J. Alarm sounds for medical equipment in intensive care and operating areas. Report AC598 to the Department of Trade and Industry, London, 1985

[19]

Patterson R.D. Guidelines for auditory warning systems on civil aircraft. Civil Aviation Authority, London 1982, Paper 82017

[20]

Salvendy G. Handbook of human factors. Wiley Interscience, 1987

[21]

Saunders M.S., McCormick E.J., editors. Human Factors in engineering and design. Seventh Edition. New York: McGraw Hill Inc, 1993

[22]

Stanford L.M., McIntyre J.W.R., Nelson T.M., Hogan J.T. Affective responses to commercial and experimental auditory alarm signals for anesthesia delivery and physiological monitoring equipment. Int J Clin Mon Comput., 1988, 5, p. 111 - 118

[23]

Tsien C.L., Fackler J.C. Poor prognosis for existing monitors in the intensive care unit. Crit Care Med., 1997, 25, p. 614 - 619

[24]

Wagner D., Birt J.A., Snyder M., Duncanson J.P. Human Factors Design Guide, FAA Technical Center For Acquisition of Commercial-Off-The-Shelf Subsystems, Final Report and Guide. Federal Aviation Administration, William J Hughes Technical Center. 1996

[25]

Wiklund M. Medical Device and Equipment Design. Usability engineering and ergonomics Buffalo Grove III.: Interpharm Press, 1995

[26]

ISO 9703-2

Anesthesia and respiratory care alarm signals - Part 2: Auditory alarm signals (withdrawn)

[27]

AAMI, Improving medical alarm systems, Horizons supplement, Bio Inst & Tech, 2011, spring

[28]

AAMI, Clinical alarms, report from the 2011 Summit [cited 2012-07-13].

Available from Internet:

<http://www.aami.org/htsi/alarms/pdfs/2011_Alarms_Summit_publication.pdf>

[29]

AAMI TIR 66, Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

[30]

ISO 8201:2017

Alarm systems - Audible emergency evacuation signal - Requirements

[31]

IEC TR 80001-2-5

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

[32]

IEC 80001-1

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

[33]

ISO 9000:2015

Quality management systems - Fundamentals and vocabulary

[34]

Belz S.M., Robinson G.S. and Casali J.G. (1999). A new class of auditory warning signals for complex systems: Auditory icons. Human factors, 41(4), p. 608 - 618

[35]

Edworthy J., Page R., Hibbard A., Kyle S., Ratnage P. and Claydon S. (2014) Learning three sets of alarms for the same medical functions: A perspective on the difficulty of learning alarms specified in an international standard. Applied Ergonomics 45(5) p. 1291 - 1296

[36]

Edworthy J.R., Reid S., Mcdougall S., Edworthy J.D., Hall S., Bennett S., Khan J. and Pye E. (2017) The recognizability and localizability of auditory alarms: setting global medical device standards. Human Factors, 59(7), p. 1108 - 1127

[37]

Graham R. (1999). Use of auditory icons as emergency warnings: evaluation within a vehicle collision avoidance application. Ergonomics, 42(9), p. 1233 - 1248

[38]

Perry N.C., Stevens C.J., Wiggins M.W. and Howell C.E. (2007). Cough once for danger: Icons versus abstract warnings as informative alerts in civil aviation. Human Factors: The Journal of the Human Factors and Ergonomics Society, 49(6), p. 1061 - 1071

[39]

Edworthy J., Loxley S. and Dennis I. (1991). Improving auditory warning design: Relationship between warning sound parameters and perceived urgency. Human factors, 33(2), p. 205 - 231

[40]

Hellier E.J., Edworthy J. and Dennis I. (1993). Improving auditory warning design: Quantifying and predicting the effects of different warning parameters on perceived urgency. Human Factors, 35(4), p. 693 - 706

[41]

Haas E.C. and Casali J.G. (1995). Perceived urgency of and response time to multi-tone and frequency-modulated warning signals in broadband noise. Ergonomics, 38(11), p. 2313 - 2326

[42]

Mondor T.A. and Finley G.A. (2003). The perceived urgency of auditory warning alarms used in the hospital operating roomis in appropriate. Canadian Journal of Anesthesia, 50(3), p. 221 - 228

[43]

Lewis B., Eisert J. and Baldwin C. (2014). Effect oft actile location, pulse duration, and interpulse interval on perceived urgency. Transportation Research Record: Journal of the Transportation Research Board, (2423), p. 10 - 14

[44]

Edworthy J. (2017) Ch. 23 Designing Auditory Alarms. In Information Design: Research and Practice (Ed: Black A., Luna P., Lund O. and Walker S.). London: Routledge, p. 377 - 390

[45]

Bolton M.L., Zheng X., Li M., Edworthy J.R. and Boyd A.D. (2019). An experimental validation of masking in IEC 60601-1-8:2006 - compliant alarm sounds. Human factors [viewed 2020-03-24]. Available at: https://doi.org/10.1177/0018720819862911

[46]

Alali K.A. and Casali J.G. (2011). The challenge of localizing vehicle backup alarms: Effects of passive and electronic hearing protectors, ambient noise level, and backup alarm spectral content. Noise and Health, 13(51), p. 99

[47]

Catchpole K.R., Mckeown J.D. and Withington D.J. (2004). Localizable auditory warning pulses. Ergonomics, 47(7), p. 748 - 771

[48]

Hasanain B., Boyd A.D., Edworthy J. and Bolton M.L. (2017). A formal approach to discovering simultaneous additive masking between auditory medical alarms. Applied Ergonomics, 58, p. 500 - 514

[49]

Laroche C., Giguere C., Vaillancourt V., Shmigol E., Rahnama M., Gravel A. and Rozon-Gauthier V. (2016). Effect of a level-dependent hearing protector on detection thresholds, perceived urgency, and localization performance of reverse alarms. The Journal of the Acoustical Society of America, 140(4), p. 3201

[50]

Laroche C., Quoc H.T., Hetu R. and Mcduff S. (1991). "Detectsound": A computerized model for predicting the detectability of warning signals in noisy workplaces. Applied Acoustics, 32(3), p. 193 - 214

[51]

Kerr J.H. (1985). Warning devices. British Journal of Anaesthesia, 57(7), p. 696 - 708

[52]

Edworthy J.R., Schlesinger J.J., Mcneer R.R., Kristensen M.S. and Bennett C.L. (2017). Classifying Alarms: Seeking Durability, Credibility, Consistency, and Simplicity. Biomedical Instrumentation & Technology, 51(s2), p. 50 - 57

[53]

Edworthy J. and Stanton N. (1995). A user-centred approach to the design and evaluation of auditory warning signals: 1. Methodology. Ergonomics, 38(11), p. 2262 - 2280

[54]

Reese T., Segall N., Nesbitt P., DelFiol G., Waller R., Macpherson B.C., Tonna J.E. and Wright M.C. (2018). Patient information organization in the intensive care setting: expert knowledge elicitation with card sorting methods. Journal of the American Medical Informatics Association, 25(8), p. 1026 - 1035

[55]

Wilken M. et al. (2017). Alarm Fatigue: Causes and Effects. Stud Health Technol Inform., 243, p. 107 - 111

[56]

AAMI (2017), Clinical Alarms: Managing the Overload. BI&T Horizons, Spring 2017, Arlington VA

[57]

Bullemer P.T., Tolsma M., Reising D.V.C., Laberge J.C. (2011) Towards improving operator alarm flood responses: alternative alarm presentation techniques. ISA Automation Week, Mobile AL

[58]

Block F.E. III, Block F.E. Jr. (2015) Decreasing False Alarms by Obtaining the Best Signal and Minimizing Artifact from Physiological Sensors. Biomed Instrum Techn, 49(6), p. 423 - 431

[59]

Block F.E. III, Block F.E. Jr. (2016) Understanding Caregiver Workflows: A Proposal for Alarm Condition Priorities. Biomed Instrum Techn, 50(2), p. 114 - 116

[60]

Siebig S., Kuhls S., Imhoff M., Gather U., J., Wrede C.E. (2010) Intensive care unit alarms - how many do we need? Crit Care Med. 38(2), p. 451 - 456

[61]

Williams S., Beatty P.C.W. (2005) Measuring the performance of audible alarms for anaesthesia. Physio IMeas. 26(4), p. 571 - 581

[62]

Sanderson P.M., Wee A., Lacherez P. (2006) Learnability and discriminability of melodic medical equipment alarms. Anaesthesia 61(2), p. 142 - 147

[63]

Lacherez P., Seah L., Sanderson P. (2006) Overlapping melodic alarms are almost indiscriminable. Human Factors. 49(4), p. 37 - 45

[64]

Wee A., Sanderson P. (2008) Are melodic medical equipment alarms easily learned? Anesth Analg. 106(2), p. 501 - 508

[65]

Block F.E. Jr. (2008) For if the trumpet give an uncertain sound, who shall prepare himself to the battle? (I Corinthians 14:8, KJV). Anesth Analg. 106(2), p. 357 - 359

[66]

Bennett C., Dudaryk R., Crenshaw N., Edworthy J. and Mcneer R. (2019). Recommendation of New Medical Alarms Based on Audibility, Identifiability, and Detectability in a Randomized, Simulation-Based Study. Critical Care Medicine, 47(8), 1050 - 1057

[67]

Edworthy J., Reid S., Peel K., Lock S., Williams J., Newbury C., Foster J. and Farrington M. (2018) The impact of workload on the ability to localize audible alarms. Applied Ergonomics, 72, p. 88 - 93

[68]

Mcneer R., Bodzin Horn D., Bennett C.L., Reed Edworthy J. and Dudaryk R. (2018) Auditory icon alarms are more accurately and quickly identified than IEC 60601-1-8 melodic alarms in a simulated clinical setting. Anesthesiology, 129(1), p. 58 - 66

[69]

Mcneer R., Bennett C.L., Horn D.B., Edworthy J. and Dudaryk R. (2017) Use of Ordinal Regression Analysis for Assessing and Comparing Individual Alarm Performance in a Simulated Intensive Care Unit Environment. Anesthesia and Analgesia 124, pp. 1120 - 1122, IARS poster, Washington DC, May 2017

[70]

Edworthy J. et al., Report on Phase 2 of the IEC 60601-1-8 audible alarms project. Report presented to AAMI upon project completion

[71]

Schlesinger et al. (2018) Acoustic features of auditory medical alarms - An experimental study of alarm volume. J Acoustical Society of America, 143(6), p. 3688

[72]

Hughson, Walter and Harold D. Westlake. (1944) Manual for Program Outline for Rehabilitation of Aural Casualties Both Military and Civilian, Sponsored by the American Academy of Ophthalmology and Otolaryngology. Douglas Print Company

[73]

AAMI Foundation. (2011) Clinical alarm: 2011 Summit convened by AAMI, FDA, TJA, ACCE and ECRI Institute [viewed 2020-03-24]. Available at: https://www.aami.org/events/eventdetail.aspx?ItemNumber=1153

[74]

Sendelbach S., Funk M. (2013) Alarm fatigue: a patient safety concern. AACN Adv Crit Care, 24(4), pp. 378 - 386

[75]

Graham K.C., Cvach M. (2010) Monitor alarm fatigue: standardizing use of physiological monitors and decreasing nuisance alarms. Am J Crit Care, 19(1), p. 28 - 34

[76]

ISO/IEEE 11073-10201:2004, Health informatics - Point-of-care medical device communication - Part 10201: Domain information model

[77]

Bliss J.P., Gilson R.D. and Deaton J.E. (1995). Human probability matching behaviour in response to alarms of varying reliability. Ergonomics, 38(11), p. 2300 - 2312

[78]

Rayo M.F. and Moffatt-Bruce S.D. (2015) Alarm system management: evidence-based guidance encouraging direct measurement of informativeness to improve alarm response. BMJ Quality and Safety, 24(4), p. 282 - 286

[79]

Wiener E.L. (1989) Human Factors of Advanced Technology ("Glass Cockpit") Transport Aircraft. NASA Contractor Report 177528, NASA Ames Research Center [viewed 2020-03-24]. Available at:

https://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/19890016609.pdf

[80]

Welch J., Rayo M., Kanter B., Bagian T., Jacobs K., Shanawani H. et al. (2016). Framework for Alarm Management Process Maturity. Biomed Instrum Techn, 50(3), p. 165 - 179

УДК 615.47:006.354

МКС 11.040.01

Ключевые слова: опасная ситуация, сигналы опасности, система сигнализации, интеллектуальная система сигнализации, изделия медицинские электрические, медицинские электрические системы