ГОСТ Р МЭК 60601-1-6-2007 Изделия медицинские электрические. Часть 1-6. Общие требования безопасности. Эксплуатационная пригодность

[1]

ISO 9241-11:1998

Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability

[2]

ANSI/AAMI HE-74:2001

Human factors design process for medical devices

[3]

ISO/IEC Guide 51:1999

Safety aspects - Guidelines for their inclusion in standards

[4]

ИСО 9000:2000

Системы менеджмента качества. Основные положения и словарь

(ISO 9000:2000)

(Quality management systems - Fundamentals and vocabulary)

[5]

IEC 61258:1994

Guidelines for the development and use of medical electrical equipment educational materials

[6]

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

[7]

Reason, J., Human Error. Cambridge, England. Cambridge University Press, 1990

[8]

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

[9]

Gundry, JW., Comess, KA., Derook, FA., Jorgenson, D. and Brady, GH. Comparison of sixth-grade children with trained professionals in the use of an automated external defibrillator. Circulation. Nov. 2000, 102(20), E166

[10]

ИСО 13485:2003

Изделия медицинские. Системы менеджмента качества. Системные требования для целей регулирования

 (ISO 13485:2003)

(Medical devices - Quality management systems - Requirements for regulatory purposes)

[11]

ANSI/AAMI HE 48:1993

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

[12]

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

[13]

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

[14]

Callan, JR., Kelly, RT., Quinn, ML., Gwynne, JW. Ill, Moore, RA., Muckler, FA., Kasumovic, J., Saunders, WM., Lepage, RP., Chin, E., Schoenfeld, I. and Serig, Dl. Human factors evaluation of remote afterloading brachytherapy. (NUREG/CR-6125, Volumes 1-3) Washington, D.C.: U.S. Nuclear Regulatory Commission, 1995

[15]

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

[16]

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

[17]

Drury, CG. 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, p.1181-1185

[18]

Sinclair, MA. Subjective assessment. In J.R.Wilson and E.N.Corlett (Eds ), Evaluation of human work. London: Tailor & Francis. 1990, p.58-88

[19]

Schuler, D. and Namioka, A. Participatory Design: Principles and Practice. Hillsdale, NJ: Lawrence Erlbaum Associates, 1993

[20]

Ellis, SR., Begault, DR., and Wenzel, EМ. Virtual environments as human computer interfaces. In M.G.Helander, Т.K.Landauer, and P.V.Prabhu (Eds.), Handbook of human-computer interaction. Amsterdam: Elsevier. 1997, p.163-201

[21]

Wiener, EL., and Nagel, DC. (Eds.) Human factors in aviation. San Diego: Academic Press, 1988

[22]

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

[23]

Fleishman, EA., and Quaintance, MK. Taxonomies of human performance: The description of human tasks. Orlando: Academic Press, 1984

[24]

Kirwan, B. and Ainsworth, LK. A Guide to Task Analysis. London, UK: Taylor and Francis, 1992

[25]

Loeb, R., Weinger, MB., and Englund, CE. Ergonomics of the anesthesia workspace. In Ehrenwerth, J. and Eisenkraft JB., Eds. Anesthesia Equipment: Principles and Applications. Malvern, PA: Mosby Year Book, 1993, p.385-404

[26]

Jonassen, DL., Hannum, WH., and Tessmer, M. Handbook of Task Analysis Procedures. Westport: Greenwood Publishing Group, 1989

[27]

Cooke, NJ. Varieties of knowledge elicitation techniques. Int'l J Human-Computer Studies. 1994, 41, p.801-849

[28]

Klein, GA., Orasanu, J., Calderwood, R., and Zsambok, CE. Decision Making in Action: Models and Methods. Norwood, New Jersey: Ablex Publishing Corp. 1993

[29]

ИСО 9001:2000 Системы менеджмента качества. Требования

(ISO 9001:2000) (Quality management systems - Requirements)

[30]

Rouse, WB. 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

[31]

Weinger, MB., Herndon, OW., and Gaba, DM. The effect of electronic record keeping and transesophageal echocardiography on task distribution, workload, and vigilance during cardiac anesthesia. Anesthesiology 1997, 87, p.144-155

[32]

Bias, R., and Mayhew, D. Cost Justifying Usability. Cambridge, MA: Academic Press, 1994