ANSI TIR60878-2003 Graphical symbols for electrical equipment in medical practice.pdf

1、 Technical Information Report ANSI/AAMI/IEC TIR60878:2003Graphical symbols for electrical equipment in medical practice The Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potential uses of an AAMIproduct standard or recommended practice are

2、 clearly understood.The objectives of AAMIs technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effective application of current technologiesto patient care, and (2) the e

3、ncouragement of new technologies. It isAAMIs view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives and provided that arbitrary and restrictive uses are avoided.A volunta

4、ry standard for a medical device recommends to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifying the device for clinical use, and the measurementtechniques that can be used to determine whethe

5、r the device conformswith the safety and performance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided with the device,including performance characteristics, instructions for use, warningsand precautio

6、ns, and other data considered important in ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the development of specialized test methods to facilitateuniformity in reporting; reaching consensus on

7、 these tests canrepresent a considerable part of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee tests must beprovided and the reasons for establishing the criteria must bedocumented in the ration

8、ale.A recommended practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures and practices that will help ensure that a device is usedsafely and effectively and that its perfor

9、mance will be maintained.Although a device standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a fume of reference for device evaluation. Similarly, eventhough a recommended practice is usually oriented towards healthcare pr

10、ofessionals, it may be useful to the manufacturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance criteria, provide guidelines to industrial personnel onsuch subjects as sterilization processing, m

11、ethods of collecting data toestablish safety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding industrial practices.In determining whether an AAMI standard or recommendedpractice is relevant to th

12、e specific needs of a potential user of thedocument, several important concepts must be recognized:All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by government regulatory orprocurement authorities). The application of a standard or recom-mended practic

13、e is solely within the discretion and professionaljudgment of the user of the document.Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professionals andindustrial representatives, whose work has been reviewed nationally(and sometimes internat

14、ionally). As such, the consensusrecommendations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recommended practice is limited,however, in the sense that it responds generally to perceived risks and

15、conditions that may not always be relevant to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecisionmaking.Despite periodic review and revision (at least once every fiveyears), a standard or reco

16、mmended practice is necessarily a staticdocument applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific rationale for each of itsprovisions. This review will reveal whether the document remainsrelevant to

17、 the specific needs of the user.Particular care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practices. While observed orpotential risks with existing equipment typically form the basis for thesafety

18、and performance criteria defined in a standard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular product as “unsafe“. A voluntary standard can be used asone resource, but the ultimate decision as t

19、o product safety andefficacy must take into account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of the specific needs andresources of the individual institution or firm. Again, the rationaleaccompanyi

20、ng each AAMI standard and recommended practice is anexcellent guide to the reasoning and data underlying its provision.In summary, a standard or recommended practice is truly usefulonly when it is used in conjunction with other sources of informationand policy guidance and in the context of professi

21、onal experience andjudgment.INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for TechnicalDevelopment. An official interpretation must be approved by letterballot of the originati

22、ng committee and subsequently reviewed andapproved by the AAMI Standards Board. The interpretation willbecome official and representation of the Association only uponexhaustion of any appeals and upon publication of notice of interpre-tation in the “Standards Monitor“ section of the AAMI News. TheAs

23、sociation for the Advancement of Medical Instrumentationdisclaims responsibility for any characterization or explanation of astandard or recommended practice which has not been developed andcommunicated in accordance with this procedure and which is notpublished, by appropriate notice, as an officia

24、l interpretation in theAAMI News.An ANSI Technical Report prepared by AAMI ANSI/AAMI/IEC TIR60878:2003Graphical symbols for electrical equipment in medical practiceApproved 10 December 2003 byAssociation for the Advancement of Medical InstrumentationRegistered 15 December 2003 byAmerican National St

25、andards Institute, Inc.Abstract: This technical information report provides a comprehensive compilation, for easy reference, ofgraphical symbols (graphics, title, description) and safety signs for medical electrical equipment.The graphical symbols are grouped in sections according to their specific

26、field of application.Keywords: electromedical equipment, graphics, safetyPublished byAssociation for the Advancement of Medical Instrumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795 2004 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedPublication, r

27、eproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of thisdocument without the prior written permission of the Association for the Advancement of Medical Instrumentation isstrictly prohibited by law. It is illegal under federal law (17 U.S.C. 101, et

28、 seq.) to make copies of all or any part ofthis document (whether internally or externally) without the prior written permission of the Association for theAdvancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, anddamages of $100,000 per offense.

29、For permission regarding the use of all or any part of this document, contact AAMIat 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067.Printed in the United States of AmericaISBN 1-57020-218-4AAMI Technical Information ReportA technical information r

30、eport (TIR) is a publication of the Association for the Advancement of Medical Instrumentation(AAMI) Standards Board that addresses a particular aspect of medical technology.Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuablebecause

31、the industry and the professions have an immediate need for it.A TIR differs markedly from a standard or recommended practice, and readers should understand the differencesbetween these documents.Standards and recommended practices are subject to a formal process of committee approval, public review

32、 andresolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the caseof American National Standards, by the American National Standards Institute.A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for dis

33、tributionby a technical committee and the AAMI Standards Board.Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10years. For

34、 a TIR, AAMI consults with a technical committee about five years after the publication date (and periodicallythereafter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or ofhistorical value. If the information is not useful, the TIR is removed

35、 from circulation.A TIR may be developed because it is more responsive to underlying safety or performance issues than a standardor recommended practice, or because achieving consensus is extremely difficult or unlikely.Unlike a standard, a TIR permits the inclusion of differing viewpoints on techni

36、cal issues.CAUTION NOTICE: This AAMI technical information report may be revised or withdrawn at any time.Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have alsoconsidered information that may be more recent than this document.All standards, r

37、ecommended practices, technical information reports, and other types of technical documentsdeveloped by AAMI are voluntary, and their application is solely within the discretion and professional judgment of theuser of the document. Occasionally, voluntary technical documents are adopted by governmen

38、t regulatory agenciesor procurement authorities, in which case the adopting agency is responsible for enforcement of its rules andregulations.Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department,1110 N. Glebe Road, Suite 220, Arlington, VA

39、22201-4795.ANSI Technical ReportThis AAMI TIR has been registered by the American National Standards Institute as an ANSI Technical Report.Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). Thisdocument is registered as a Technical Report series

40、 of publications according to the Procedures for the Registrationof ANSI Technical Reports. This document is not an American National Standard and the material contained herein isnot normative in nature.Comments on the content of this document should be sent to AAMI, 1110 N. Glebe Road, Suite 220, A

41、rlington, VA22201-4795.ContentsPageGlossary of equivalent standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viCommittee representation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

42、 . . . . . . . . . . . . . . . . . . viiiBackground of AAMI adoption of IEC/TR 60878:2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixForeword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

43、 . . . . . . . . . . . . . . . . . . . xIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

44、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Normative references . . . . . . . . . . . . . . . . . . . . . . . . .

45、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Graphical survey. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34.1 Overview 1General: Controls . . . . . . . . . . . . . . . . .

46、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44.2 Overview 2General: Movement related . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54.3 Overview 3General: Electricity and electronics . . . . . . . . . . . . . . . . . . . . . . . . . .

47、 . . . . . . . . . . 64.4 Overview 4General: Light and optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74.5 Overview 5General: Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84.6 Overview 6Tr

48、ansport, handling, and packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94.7 Overview 7Safety related . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104.8 Overview 8Safety signs . . . . . . . . . . . . . . .

49、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114.9 Overview 9Classification and identification of equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124.10 Overview 10Information and communication: Image, imaging . . . . . . . . . . . . . . . . . . . . . . . . 134.11 Overview 11Information and communication: Audio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144.12 Overview 12Information and communication: Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154.13 Overview 13Patient/per