ANSI ID26-2004 Medical electrical equipment-Part 2 Particular requirements for the safety of infusion pumps and controllers.pdf

1、ANSI/AAMI ID26:2004/(R)2013Medical electrical equipmentPart 2: Particular requirements for the safety of infusion pumps and controllersAmerican National StandardThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potential uses of an AAMIpro

2、duct 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 application of current t

3、echnologiesto 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 provided that arbitrary a

4、nd 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 the measurementtechni

5、ques 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 characteristics, in

6、structions 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 to facilitateunifo

7、rmity 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 for establishing the

8、 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 that a device is useds

9、afely 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 recommended practice

10、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 industrial personnel onsuc

11、h 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 whether an AAMI standard

12、 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 authorities). The applicat

13、ion 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, whose work has been r

14、eviewed 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 the sense that it

15、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 revision (at least

16、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. This review will revea

17、l 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 with existing equipmen

18、t 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 can be used asone

19、 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 individual institutio

20、n 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 informationand polic

21、y 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 interpretation must be

22、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 in the “Standards

23、 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 which is notpublis

24、hed, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI ID26:2004/(R)2013 (Revision of ANSI/AAMI ID26:1998) CORRECTED COPY Medical electrical equipment Part 2: Particular requirements for the safety of infusion pumps and controllers Approved 2 D

25、ecember 2004 by Association for the Advancement of Medical Instrumentation Approved 9 December 2004 and reaffirmed 26 November 2013 by American National Standards Institute, Inc. Abstract: This standard establishes minimum labeling, safety, performance, and testing requirements for electromechanical

26、 infusion devices that have a pumping or gravity-feed controlling function, that deliver fluid from either a separate or a self-contained source, and that are intended for use with parenteral fluids for such purposes as parenteral nutrition and administration of drugs and routine fluids. Keywords: c

27、ontroller, infusion, pump, syringe AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they

28、 have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be r

29、evised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards,

30、recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by govern

31、ment regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2005 by the Association f

32、or the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of IEC, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI.

33、All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical

34、Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 52

35、5-1067. Printed in the United States of America ISBN 157020227-3 Contents Glossary of equivalent standards .v Committee representation vii Foreword. viii Introduction .ix AAMI deviations from IEC 60601-2-24:1998x SECTION ONEGENERAL 1 Scope and object .1 2 Terminology and definitions .2 3 General req

36、uirements 4 5 Classification5 6 Identification, marking, and documents5 SECTION TWOENVIRONMENTAL CONDITIONS 10 Environmental conditions.8 SECTION THREEPROTECTION AGAINST ELECTRIC SHOCK HAZARDS 14 Requirements related to classification .8 17 Separation .8 19 Continuous LEAKAGE CURRENTS and PATIENT AU

37、XILIARY CURRENTS .8 SECTION FOURPROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength.10 SECTION FIVEPROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 36 Electromagnetic compatibility.10 SECTION SIXPROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANESTHETIC MIXTURES SECTION S

38、EVENPROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection, and compatibility 12 47 Electrostatic charges13 49 Interruption of the power supply.13 SECTION EIGHTACCURACY OF OPERATING DATA A

39、ND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data 13 51 Protection against hazardous output30 SECTION 9ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS SECTION TENCONSTRUCTIONAL REQUIREMENTS 54 General34 56 Components and general assembly.35 Appendix/Annex L References

40、Publications mentioned in this standard.35 AA General guidance and rationale.37 Tables 101 Vibration value .10 102 Set rates, BOLUS volumes, and test apparatus for the accuracy tests of 50.102 to 50.108.30 Figures 101 PATIENT LEAKAGE CURRENT external power supply .9 102 PATIENT LEAKAGE CURRENTINTERN

41、AL ELECTRICAL POWER SOURCE9 103 Analysis periods.17 104a Test apparatus for VOLUMETRIC INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS 18 104b Test apparatus for SYRINGE PUMPS18 105 Start-up graph plotted from data gathered during the first 2 h of the test period19 106 Trumpet curve plotted from

42、data gathered during the second hour of the test period19 107 Trumpet curve plotted from data gathered during the last hour of the ADMINISTRATION SET CHANGE INTERVAL 19 108 Test apparatus for DRIP-RATE INFUSION PUMPS and DRIP-RATE INFUSION CONTROLLERS21 109 Start-up graph plotted from data gathered

43、during the first 2 h of the test period21 110 Start-up graph over the stabilization period24 111 Trumpet curve plotted from data at the end of the stabilization period.24 112 Start-up curve over the stabilization period for quasi-continuous output pumps 24 113 Trumpet curve plotted from data at the

44、end of the stabilization period for quasi-continuous pumps25 114 Test apparatus to determine the OCCLUSION ALARM THRESHOLD (PRESSURE) and BOLUS volumes 32 AA.3.1 Start-up graph42 AA.3.2 Trumpet curve43 AA.3.3 Calculation for Ep(max.) and Ep(min.) 46 AA.4.1 Sampling protocol 47 AA.4.2 Observation win

45、dows.48 AA.4.3 Distribution of parent variate X.48 AA.4.4 Distribution of observation windows.49 AA.4.5 The statistical trumpet graph50 Glossary of equivalent standards International standards adopted in the United States may include normative references to other international standards. For each in

46、ternational standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the international standard. (Note: Documents are sorted by international designation.) Other normatively referenced international standards may be under

47、 consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1-2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major

48、 technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated t

49、exts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical ISO 5840:200x1ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:1992 ANSI/AAMI/ISO 10993-2:1993/(R)2001 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 ANSI/AAMI/ISO 10993-4:2002 Id