AAMI-HE48-1993.pdf
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1、AAMI Standard AAMI HE48:1993 AAMI Association for the Advancement of Medical Instrumentation Human factors engineering guidelines and preferred practices for the design of medical devices Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Lic
2、ensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:44:55 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI HE48:1993 (Revision of AAMI HE:1988) Human factors engineering guidelines and preferred practices for the design of medical devices NOT
3、E: In the course of the AAMI Human Factors Engineering Committees most recent review of HE48:1993, Human factors engineering guidelines and preferred practices for the design of medical devices, the committee decided that standards users would be better served if the document was divided into separa
4、te standards covering: (1) human factors design process, and (2) human factors design principles. The human factors design process (previously addressed in section 5 of the 1993 standard) is now addressed in the new American National Standard, Human factors design process for medical devices, and is
5、 designated ANSI/AAMI HE74:2001. Human factors design principles are being addressed in a new standard under development by the AAMI Human Factors Engineering Committee. The new design principles standard will carry the designation HE75. Until that document is published, standards users can refer to
6、 HE48 for recommendations concerning human factors design principles. ANSI/AAMI HE74:2001, Human factors design process for medical devices, was originally designated ANSI/AAMI HE48:2001. It was later redesignated ANSI/AAMI HE74:2001. HE74 is a partial revision of HE48. ANSI/AAMI HE48:1993 has been
7、withdrawn administratively as an American National Standard. However, the AAMI Human Factors Engineering Committee requested that copies of HE48 remain available while the committee develops HE75. Therefore, HE48 remains available to the public as AAMI HE48:1993 and any reference to it as an America
8、n National Standard is no longer appropriate. November 2001 Developed by Association for the Advancement of Medical Instrumentation Abstract:The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, sy
9、stem safety and performance, and operator effectiveness will be reflected in medical device design. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:44:55 MD
10、TNo reproduction or networking permitted without license from IHS -,-,- Association for the Advancement of Medical Instrumentation 1110 N. Glebe Rd., Suite 220 Arlington, VA 22201-4795 2000 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Copyright and Permission
11、s Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of these documents without the prior written permission of the Association for the Advancement of Medical Instrumentation or the copyright holder (if not AAMI) is prohibited by law. I
12、t is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of these documents (whether internally or externally) without the prior written permission of the copyright holder. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 p
13、er offense. For permission regarding the use of all or any part of these documents, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Violators of this copyright policy should be reported to AAMIs legal counsel: McKenna “should“ indica
14、tes that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is no
15、t prohibited; “may“ is used to indicate a course of action is permissible within the limits of the recommended practice; and “can“ is used as a statement of possibility and capability. “Must“ is used only to describe “unavoidable“ situations, including those mandated by government regulation. The co
16、ncepts incorporated in this recommended practice should not be considered static. Recommendations must be reviewed and updated periodically to assimilate new data and technological developments. Use of trade names and citation of proprietary devices does not constitute endorsement. Suggestions for i
17、mproving this recommended practice are invited. Comments and suggested revisions should be sent to AAMI, 3330 Washington Boulevard, Suite 400, Arlington, Virginia 22201. NOTEThis foreword does not contain provisions of the American National Standard, Human factors engineering guidelines and preferre
18、d practices for the design of medical devices (ANSI/AAMI HE481993), but does provide important information about its development and use. Human factors engineering guidelines and preferred practices for the design of medical devices 1 Scope This recommended practice deals with the controls, displays
19、, consoles, size, weight, and general user interface design of medical devices. User instructions, manuals, software, and algorithms associated with medical devices are only briefly discussed and the reader should refer to additional appropriate materials and sources for further information. NOTERec
20、ommendations concerning documentation to be provided by medical device manufacturers are given in the AAMI Guideline for establishing and administering medical instrumentation maintenance programs (AAMI MIR2, 1992). The provisions of this recommended practice are not intended to be inflexible design
21、 requirements nor to limit advancement, but to encourage the development of new technology provided that it meets or exceeds the intent of the general human factors engineering (HFE) design recommendations contained within. 2 Normative references The following documents contain provisions that throu
22、gh reference herein, constitute provisions of this recommended practice. At the time of publication, the editions indicated were current. AMERICAN NATIONAL STANDARDS INSTITUTE. Breathing machines for medical use. ANSI Z79.6. New York: ANSI, 1975. AMERICAN NATIONAL STANDARDS INSTITUTE. Components and
23、 systems of continuous-flow anesthesia machines for human use, Minimum performance and safety requirements for. ANSI Z79.8. New York: ANSI, 1979. AMERICAN NATIONAL STANDARDS INSTITUTE. Criteria for safety symbols. ANSI Z535.3. New York: ANSI, 1991. AMERICAN NATIONAL STANDARDS INSTITUTE. Environmenta
24、l and facility safety signs. ANSI Z535.1. New York: ANSI, 1991. AMERICAN NATIONAL STANDARDS INSTITUTE. Measurement and designation of noise emitted by 2000 Association for the Advancement of Medical Instrumentation Copyright Association for the Advancement of Medical Instrumentation Provided by IHS
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