ГОСТРМЭК 62366—2013
design guidance for office systems software. The individual parts cover dialogue boxes, form filling, menus, command,
and direct manipulation dialogues, presentation of information, and user guidance
National Committee for Clinical Laboratory Standards. (1996) Laboratory instruments and data management
systems: Design of software user interfaces and user software systems validation, operation, and monitoring. NCCLS GP-
19-P. Vlllanova, PA: NCCLS. Describes software design principles that will facilitate the safe, efficient use of clinical
laboratory diagnostic medical device
U.S. Department of Defense. (1996). Department of Defense design criteria standard. MIL-STD-1472F. Washington,
D.C.: DOD. A general guidelines document pertinent to systems design of military systems, although not directly applicable
to medical systems
U.S. Department of Defense. (1998). Human engineering design guidelines. MIL-HDBK-759C. Washington, D.C.:
DOD. A handbook covering the general area of human factors. As in MIL-STD-1472F. this is a handbook, designed to
provide guidelines, not standards
U.S. Department of Defense. (1998). Human engineering program processes and procedures. MIL-HDBK-46S55A.
Washington D.C.: DOD. A general guideline on human engineering program processes and procedures
BACKINGER, C. and KINGSLEY. P. (1993). Write it right: Recommendations for developing user instruction manuals
for medical devices used in home health care, (HHS Pub. FDA 93-4258). Rockville. MD.: U.S. Department of Health and
Human Services, Food and Drug Administration. A brief document that provides FDA recommendations for writing
instruction manuals for home-use medical devices
KAY, R. and CROWLEY, J. (2000). Medical Device Use — Safety: Incorporating Human Factors Engineenng into
Risk Management. Washington. D.C.: U.S. Health and Human Services. Food and Drug Administration. A guidance
document that describes the human factors process in the risk management context and makes recommendations
for relevant materials for inclusion in pre-market submissions
SAWYER. D. (1996). Do It By Design: An Introduction to Human Factors in Medical Devices. Washington DC: U.S.
Health and Human Services, Food and Drug Administration. A primer that discusses user interface problems, design
rules-of-thumb. and human factors process in medical devices based upon the experiences of the FDA staff
ISO 13407:1999, Human-centred design processes for interactive systems
ISO 13529:2000. Ergonomics — Ergonomics of human-system interaction — Human-centred lifecycle process
descriptions
I.8 Интернет-ресурсы
U.S. Food and Drug Administration — httpV
/www.fda.gov/cdrh/humanfactors
Human Factors and Ergonomics Society —
http://www.hfes.org
Association for Computing Machinery. Special Interest Group on Computer-Human Interaction — http./Avww.acm.org/
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