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Ansi Aami He48 1993
Ansi Aami He48 1993
Ansi Aami He48 1993
Standard
AAMI
Association for the
Advancement of Medical
Instrumentation
Association for the Advancement
of Medical Instrumentation
1110 N. Glebe Rd., Suite 220
Arlington, VA 22201-4795
Human factors engineering guidelines and preferred practices for the design of
medical devices
American National Standard
ANSI/AAMI HE48—1993
(Revision of AAMI HE—1988)
Developed by
Association for the Advancement of Medical Instrumentation
Approved 16 September 1993 by
American National Standards Institute, Inc.
Abstract:
The purpose of this recommended practice is to provide ergonomic information and human factors
engineering guidance so that optimum user and patient safety, system safety and performance, and operator
effectiveness will be reflected in medical device design.
Association for the Advancement of Medical Instrumentation
Human Engineering Committee
This recommended practice was developed by the AAMI Human Engineering Committee. Committee
approval of the recommended practice does not necessarily imply that all committee members voted for its
approval.
The AAMI Human Engineering Committee has the following members:
Cochairs: Frank E. Block, Jr., MD
Christopher R. Goodrich
Members: M. Lee Bancroft, Beth Israel Hospital
Frank E. Block, Jr., MD, University of Arkansas for Medical Sciences
Peter Carstensen, Center for Devices and Radiological Health, Food and Drug
Administration
Gerald Chaikin, PE, CPE, NAS, Inc.
Richard I. Cook, MD, Ohio State University Hospital
Larry T. Dallen, MD, University of British Columbia
Thomas C. Deas, MD
Larry Feenstra, Loma Linda University Medical Center
Christopher R. Goodrich, Ohmeda-Anesthesia
David L. Johnson, PhD, BC Institute of Technology
Carl A. Pantiskas, SpaceLabs Medical, Inc.
Susan K. Plahn, Quinton Instrument Company
Paula Sind Prunier, PhD, ErgoMed Analytics, Inc.
Alan K. Reeter, CCE, Reeter & Associates
Leslie Rendell-Baker, MD, Jerry Pettis VA Hospital
Continuous Momentary
contact contact
Metallic 55°C 60°C
Glass 65°C 70°C
Plastic or Wood 75°C 85°C
(IEC 601-1, 1988 and UL 544)
6.4.4 Maintainability
6.4.4.1 Cleaning
Device surfaces should be smooth and free of pockets and crevices. The surface finish should withstand
commonly used cleaning and disinfecting agents. The outer casing should prevent cleaning solutions and
solvents from penetrating mechanical and electrical components, which might result in operator hazard or
mechanical failure. Devices should withstand the effects of commonly used bactericidal, fungicidal, and
virucidal disinfectants even when applied after each patient use for an extended period.
NOTE—The manufacturer should advise the user about suitable cleaning, disinfection, radiological
decontamination, and sterilization agents, methods, and intervals and about any special precautions to be
observed. AAMI MIR2-1992 specifies the information to be provided by device manufacturers with respect
to cleaning, sterilization, and intervals.
6.4.4.2 Lamp testing/removal
Means should be provided to ensure that lamps in indicators are operable. Where possible, provision should
be made for rapid, convenient removal of the lamp from the front of the display panel or for other means of
verifying operation without compromising the lamp's resistance to fluid penetration. Display circuits should
be designed so that externally accessible bulbs may be removed and replaced when power is applied without
causing indicator circuit components to fail and without imposing personnel safety hazards.
6.4.5 Damage prevention and stability
Systems and equipment should be sufficiently rugged to withstand handling during operation, maintenance,
supply, and transport within the environment in which they are used.
6.4.5.1 Component protection
Controls, connectors, and other device components susceptible to damage should be recessed or otherwise
protected.
6.4.5.2 Mobile devices
Free-standing mobile devices should be stable and designed to eliminate tipping in normal use and
servicing. Casters should be used to help move equipment in and out of elevators or across uneven sections
NOTE—Increase dimension 'A' to 107 cm (42") and 'B' to 147 cm (58") for standing operation with
lookover requirement to maintain the same relationships.
9.7.2.1 Application
Thumbwheels may be either discrete or continuous controls. A discrete thumbwheel may be used if the
function requires a compact digital control input device (for a series of numbers) and a readout of these
manual inputs for verification. Detent indexing units should provide 10 positions (0 to 9) in digital outputs.
For binary detent indexing, there should be 3 or 4 bits and complement outputs. A continuous thumbwheel
may be used for applications requiring continuous adjustment.
9.7.2.2 Shape
Minimum Maximum
Width (spanned 40 mm (1.6 70 mm (2.8
by thumb to fin- inches) inches)
ger grasp)
Length 70 mm (2.8 inches) 120 mm (4.7
inches)
Thickness 25 mm (1.0 inches) 40 mm (1.6 inches)
(From MIL-STD-1472D)
Annex 1
(Informative)
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