ГОСТ РМЭК 62366— 2013
GABA. D. М. (1994). Human work environment and simulators. In R. D. Miller (Ed.). Anesthesia (Fourth Edition).
New York: Churchill Livingstone, pp. 2635—2680. An overview of performance shaping factors in anesthesia care and of
the use of realistic clinical simulators for testing of critical care medical devices
GOPHER: D.. OLIN. M.. BADIHI. Y.. COHEN. G.. DONCHIN. Y.. BIESKI. M.. and COTEV. S. (1989). The nature and
causes of human errors in a medical intensive care unit. Proceedings of the Human Factors Society 33rd Annual Meeting (pp.
956—960). Santa Monica. CA: Human Factors Society. Describes the results of a two-year study conducted in a
respiratory intensive care unit in which errors were recorded and analyzed
GOSBEE. J. W. (1997). The discovery phase of medical device design: A blend of intuition, creativity, and science.
Medical Device & Diagnostic Industry. Vol. 19. pp. 79-S2. Using human factors methods in the early stages of device
development enables designers to meet the needs of end-users
GOSBEE. J. W.. and Ritchie. E. M. (1997). Human-Computer Interaction and Medical Software Development.
Interactions. Vol. 4. no. 4. New York: ACM Press pp. 13-1S. Describes and gives examples of the unique methods,
resources, and considerations for doing human factors engineering in a medical setting
GURUSHANTHAIAH. K.: WEINGER. M. B.. and ENGLUND. С. E. (1995). Visual display format affects the ability of
anesthesiologists to detect acute physiological changes. Anesthesiology 83:1184—1193. Describes a scientific laboratory
based approach to the evaluation of a clinical display. Demonstrates the importance of studying actual users (e.g..
anesthesiologists) who yielded different results than educated non-clinicians
JOHNSON. C. Ed. (1999). Proceedings of the First Workshop in Human Error and Clinical Systems (HECS 99)
(Glasgow Accident Analysis Group Technical Report G99-1). Glasgow. Scotland: Department of Computer Science.
University of Glasgow. Proceedings of a conference held April 15-17, 1999. Includes papers on medical incident reporting,
diagnosis and treatment support tools, medical risk analysis, and human error in the medical workplace
LEAPE. L. L. BRENNAN. T. A.. LAIRD. N.. LAWTHERS. A. G., LOCALIO. A. R.. BARNES. B. A.. HERBERT. L.
NEWHOUSE: J. P.: WEILER: P. C. and HIATT. H. (1991). The nature of adverse events in hospitalized PATIENTS: Results of
the Harvard Medical Practice Study II. New England Journal of Medicine. 324 (6): 377—331. This study looks in detail at
the incidence of hospital-based medication errors
LE COCQ. D. (1937). Application of human factors engineering in medical product design. Journal of Clinical
Engineering, 12 (4): 271—277. Description of the HFE design process utilizing applications to a family of infusion
devices to illustrate the methodologies
LOEB. R.. WEINGER. M. B.. and ENGLUND. С. E. (1993). Ergonomicsoftheanesthesia workspace. EHRENWERTH.
J. and EISENKRAFT. J. B.. editors. Anesthesia Medical device: Principles and Applications. Mosby Year Book. Malvern. PA.
pp. 385-404. A general review of HFE issues in the anesthesia work domain
VOORHORST. F.. OVERBEEKE. C.. and SMETS, G. (1998). Spatial perception during laparoscopy: implementing
action-perception coupling. In Proceedings of Medicine Meets VR-5. San Diego. CA. Jan. 22-25. 379—386. A summary of
some of the HFE issues associated with laparoscopic instruments
WEBSTER. J. G., (Ed.) (1997). Design of Pulse Oximeters. Institute of Physics Publishing. Philadelphia. PA.
Describes the equations, methods, hardware, and software needed to make a pulse oximeter, which provides early
information on problems with the delivery of oxygen to tissue
WEINGER. M. B.. HERNDON. O. W.. and GABA. D. M. (1997). The effect of electronic record keeping and
transesophageal echocardiography on task distribution, workload, and vigilance during cardiac anesthesia. Anesthesiology
87:144— 155. Describes the use of objective HFE techniques (including time-motion analysis, workload analysis, and
secondary task probing) to study in the actual work domain the effects of the introduction of new medical technologies on
users’ clinical performance
* WJKLUND. M. E. (1995). Medical device and medical device design: Usability Engineering and Ergonomics.
Englewood, Colorado: Interpharm Press Inc. Practical guidance on how to incorporate human factors engineering
principles into the design of medical devices and medical device, including the software, hardware, and paper-based
components. It also serves as a primer on an assortment of design and evaluation techniques, such as task analysis, user
interface design, rapid prototyping, and usability
* WIKLUND. M. E. and WILCOX. S. B. (2005) (Eds) Designing Usability into Medical Products. CRC Press
WRIGHT. J. G.. McGEER. A. J.. CHYATTE. D.. RANSOHOFF. D. F. (1991). Mechanisms of glove tears and sharp
injuries among surgical personnel. Journal of the American Medical Association. 266. 1668— 1671. Describes the ways
in which glove tears and sharp injuries occur as a prelude to design improvements
1.7 Международные публикации
Association for the Advancement of Medical Instrumentation. (1993). Human factors engineering guidelines and
preferred practices for the design of medical devices. ANSI/AAM HE 48-1993. Arlington. VA: AAMI. This is the previous
verson of the current AAMI HFE 48:2000. The information is still relevant but has been expanded in the current version
American National Standards Institute. (1988). American National Standard for human factors engineering of
visual display terminal workstations. ANSl/HFS 100-1938. New York: ANS The ANSI version of the first nine parts of
ISO 9241, this standard provides ergonomic guidance and requirements for the design of video display terminals,
including visual displays, keyboards and other input devices, and workstatiorv’computing environments
International Organization for Standardization. (1996). Ergonomic requirements for office work with visual display
terminals (VDTs)— Parts 10-17. ISO 9241 series. Geneva. Switzerland. This standard provides detailed user interface
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