ANSI-AAMI-SP10-2002 Manual, electronic, or automated sphygmomanometers.pdf

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1、AmericanNationalStandardANSI/AAMI SP10:2002AAMIAssociation for theAdvancement of MedicalInstrumentationManual, electronic,or automatedsphygmomanometers& ANSI/AAMI SP10:2002/A1:2003The Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potential

2、 uses of an AAMIproduct standard or recommended practice are 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 appli

3、cation of current technologiesto patient care, and (2) the encouragement 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 provid

4、ed that arbitrary and restrictive uses are avoided.A voluntary 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 th

5、e measurementtechniques that can be used to determine whether 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

6、characteristics, instructions for use, warningsand precautions, 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

7、 to facilitateuniformity in reporting; reaching consensus on 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 f

8、or establishing the criteria must bedocumented in the rationale.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 tha

9、t a device is usedsafely and effectively and that its performance 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 re

10、commended practice is usually oriented towards healthcare professionals, 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 industr

11、ial personnel onsuch subjects as sterilization processing, methods 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 wheth

12、er an AAMI standard or recommendedpractice is relevant to the 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 authori

13、ties). The application of a standard or recom-mended practice 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, wh

14、ose work has been reviewed nationally(and sometimes internationally). 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

15、 the sense that it responds generally to perceived risks andconditions 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

16、revision (at least once every fiveyears), a standard or recommended 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. Thi

17、s review will reveal whether the document remainsrelevant to 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 wit

18、h existing equipment typically form the basis for thesafety 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

19、can be used asone resource, but the ultimate decision as to 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 indi

20、vidual institution or firm. Again, the rationaleaccompanying 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 inf

21、ormationand policy guidance and in the context of professional 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 interp

22、retation must be approved by letterballot of the originating 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

23、in the Standards Monitor section of the AAMI News. TheAssociation 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 whi

24、ch is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI SP10:2002 & ANSI/AAMI SP10:2002/A1:2003(Revision of ANSI/AAMI SP9:1994;ANSI/AAMI SP10:1992; andANSI/AAMI SP10:1992/A1:1996)Manual, electronic, or automatedsphygmomanometersDe

25、veloped byAssociation for the Advancement of Medical InstrumentationApproved 28 October 2002 byAmerican National Standards Institute, Inc.Abstract: This standard establishes labeling, safety, and performance requirements for sphygmomano-meters, including electronic, electromechanical, and nonautomat

26、ed devices that are used in theindirect measurement of blood pressure. Ambulatory blood pressure monitors, which areportable, lightweight, automated devices worn or carried by the patient that are able to obtain andstore the results of repeated determinations of blood pressure and heart rate during

27、activities ofordinary daily living, also are included in the scope of this document.Keywords: blood pressure, electromedical equipment, heart rate, sphygmomanometerAAMI StandardThis Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of thosesubstantially c

28、oncerned with its scope and provisions. The existence of an AAMI standard does not in any respectpreclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, orusing products, processes, or procedures not conforming to the standard. AAMI standards are s

29、ubject to periodicreview, and users are cautioned to obtain the latest editions.CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require thataction be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication

30、.Interested parties may obtain current information on all AAMI standards by calling or writing AAMI.All AAMI standards, recommended practices, technical information reports, and other types of technical documentsdeveloped by AAMI are voluntary, and their application is solely within the discretion a

31、nd professional judgment ofthe user of the document. Occasionally, voluntary technical documents are adopted by government regulatoryagencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rulesand regulations.Published byAssociation for the Advan

32、cement of Medical Instrumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795 2003 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of thisdo

33、cument 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 seq.) to make copies of all or any part ofthis document (whether internally or externally) without the prior

34、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. For permission regarding the use of all or any part of this document, contactAAMI at 1110 N. Glebe Road, Suite

35、 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067.Printed in the United States of AmericaISBN 1570201838ContentsPageGlossary of equivalent standards.viCommittee representation. viiiIn memoriam.ixAcknowledgements.ixForeword.x1 Scope.11.1 General .11.2 Inclusions.11.3 Exclusio

36、ns.12 Normative references .13 Definitions.24 Requirements .34.1 Labeling requirements .34.1.1 General.34.1.2 Device and outer container labeling .34.1.3 Information manual.34.1.4 Component labeling.44.2 Environmental performance and stability.54.2.1 Storage conditions.54.2.2 Operating conditions.54

37、.2.3 Vibration and shock .54.2.4 Stability .54.2.5 Electromagnetic compatibility.64.3 Safety requirements.64.3.1 Devices incorporating automatic inflation systems.64.3.2 Electrical safety .64.3.3 Conductive components .64.4 Performance requirements .64.4.1 Aneroid manometers .64.4.2 Mercury manometers.64.4.3 Electronic manometers.64.4.4 Pressure transducer accuracy.64.4.5 Overall system efficacyAutomated systems.74.