Статус документа
Статус документа

ГОСТ Р МЭК 60601-1-8-2007 Изделия медицинские электрические. Часть 1-8. Общие требования безопасности. Общие требования, испытания и руководящие указания по применению систем сигнализации медицинских электрических изделий и медицинских электрических систем

     

Библиография

[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, FE. Jr., ROUSE, JD., HAKALA, M., THOMPSON, CL. 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, FE. Jr., SCHAAF, С. Auditory alarms during anesthesia monitoring with an integrated monitoring system. Intl J Clin Monit Comput, 1996, 13, p.81-84

[9] BLOCK, FE. 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, FE. 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, IG; MILLER, BR., LOCKHART, CH. Auditory alarms during anesthesia monitoring. Anesthesiology, July, 1988, 69:1, p.106-9

[14] LAWLESS, ST. 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, TM. 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, RD., EDWORTHY, J., SHAILER, MJ. Alarm sounds for medical equipment in intensive care and operating areas. Report AC598 to the Department of Trade and Industry, London, 1985

[19] PATTERSON, RD. 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, MS., McCORMICK, EJ., Editors. Human Factors in engineering and design. Seventh Edition. New York: McGraw Hill Inc, 1993

[22] STANFORD, LM., McINTYRE, JWR., NELSON, TM., HOGAN, JT. 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, CL., FACKLER, JC. Poor prognosis for existing monitors in the intensive care unit. Crit Care Med., 1997, 25, p.614-619

[24] WAGNER, D., BIRT, JA., SNYDER, M., DUNCANSON, JP. 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 Ill.: Interpharm Press, 1995

[26] ISO 9703-2, Anesthesia and respiratory care alarm signals - Part 2: Auditory alarm signals



Электронный текст документа

подготовлен ЗАО "Кодекс" и сверен по:

официальное издание

М.: Стандартинформ, 2008