1、Cardiovascular implantsCardiac valve prosthesesAssociation for the Advancementof Medical InstrumentationANSI/AAMI/ISO 7198:1998/2001/(R)2010Cardiovascular implantsTubular vascular prosthesesThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and
2、 potential 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 effec
3、tive application 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
4、and provided 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 u
5、se, and the 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 pe
6、rformance 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 te
7、st methods 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
8、 reasons for 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
9、ensure that 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, event
10、hough a recommended 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
11、to industrial 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 determi
12、ning whether 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 orprocureme
13、nt authorities). 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 represent
14、atives, whose 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,h
15、owever, in 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 r
16、eview and 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 itsprovi
17、sions. This 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
18、 risks with 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 volunta
19、ry standard 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
20、 of the individual 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 so
21、urces of informationand 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 off
22、icial interpretation 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 inte
23、rpre-tation 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 pro
24、cedure and which is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI/ISO 7198:1998/2001/(R)2010(Revision of ANSI/AAMI VP20:1994)Cardiovascular implantsTubular vascular prosthesesApproved 24 September 2001 byAssociation for the Ad
25、vancement of Medical InstrumentationApproved 17 October 2001 and reaffirmed 22 April 2010 byAmerican National Standards Institute, Inc.Abstract: This American National Standard provides basic requirements for sterile vascular prostheses andthe methods of test which will enable evaluation of vascular
26、 prostheses.Keywords: biological, component, leakage, permeability, materialAAMI StandardThis Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of thosesubstantially concerned with its scope and provisions. The existence of an AAMI standard does not in an
27、y 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 subject to periodicreview, and users are cautioned to obtain the latest editions.CAUTION
28、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 5 years from the date of publication.Interested parties may obtain current information on all AAMI standards by calling or writ
29、ing 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 and professional judgment ofthe user of the document. Occasionally, voluntary technical docu
30、ments 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 Advancement of Medical Instrumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795 2001
31、 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedThis publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproducedor distributed in any form, including an electronic retrieval system, without the prior written pe
32、rmission of AAMI. Allrequests pertaining to this draft 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 writtenpermission of the Association for the Advancement
33、 of Medical Instrumentation. Violators risk legal action, includingcivil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or anypart of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax
34、: (703) 525-1067.Printed in the United States of AmericaISBN 1570201692ContentsPageGlossary of equivalent standardsviCommittee representation.viiiBackground of ANSI/AAMI adoption of ISO 7198:1998 ixForeword . xIntroductionxi1 Scope. 12 Normative references. 13 Terms and definitions. 24 General requi
35、rements 44.1 Configuration and size designation . 44.1.1 Uniform straight vascular prostheses 44.1.2 Bifurcated uniform vascular prostheses 44.1.3 Tapered vascular prostheses 44.1.4 Other configurations 44.2 Intended clinical use designation 44.3 Materials and construction 44.3.1 Classification. 44.
36、3.2 Nomenclature 54.4 Biocompatibility and biostability. 54.4.1 Biocompatibility. 54.4.2 Biostability. 54.5 Sterility. 64.6 General information and instructions for use. 64.7 Packaging 64.7.1 Unit container64.7.2 Outer container . 64.7.3 Shipping container 64.8 Marking 64.8.1 Container label 64.8.2
37、Record label74.9 Test reports . 74.9.1 General . 74.9.2 Additional information . 85 Requirements for finished prosthesis. 85.1 Visual inspection . 95.2 Porosity, water permeability, integral water permeability/leakage, and water entry pressure . 95.2.1 Porosity . 95.2.2 Water permeability 95.2.3 Int
38、egral water permeability/leakage 95.2.4 Water entry pressure 95.3 Strength. 95.4 Length . 105.5 Relaxed internal diameter . 105.6 Pressurized internal diameter 105.7 Wall thickness . 105.8 Suture retention strength. 105.9 Kink diameter/radius 105.10 Compliance . 116 Requirements for in vivo preclini
39、cal and clinical evaluation . 116.1 In vivo preclinical testing .116.2 Clinical evaluation . 117 Sampling 127.1 Sampling for characterization 127.2 Sampling for quality control. 127.2.1 Random sampling . 127.2.2 Time interval sampling 127.2.3 Number of samples. 128 Test methods for vascular prosthes
40、es . 128.1 Visual inspection (A) 138.1.1 Principle 138.1.2 Apparatus 138.1.3 Sampling . 138.1.4 Test procedure 138.1.5 Expression of results. 138.1.6 Test reports and additional information. 138.2 Determination of porosity, water permeability, integral water permeability/leakage, and water entry pre
41、ssure 138.2.1 Determination of porosity (N) 138.2.2 Determination of water permeability (T, C) . 168.2.3 Determination of integral water permeability/leakage (B, C). 198.2.4 Determination of water entry pressure (N) 198.3 Determination of strength 208.3.1 Determination of circumferential tensile str
42、ength (A) 208.3.2 Determination of longitudinal tensile strength (A) . 228.3.3 Determination of burst strength (A). 238.3.4 Determination of strength after repeated puncture (A, if applicable) 278.4 Determination of usable length (A)288.4.1 Principle 288.4.2 Apparatus 288.4.3 Sampling . 298.4.4 Test
43、 procedure 298.4.5 Expression of results. 298.4.6 Test report and additional information 298.5 Determination of relaxed internal diameter (A) 298.5.1 Principle 298.5.2 Apparatus 298.5.3 Sampling . 298.5.4 Test procedure 318.5.5 Expression of results. 318.5.6 Test report and additional information 31
44、8.6 Determination of pressurized internal diameter (A). 318.6.1 Principle 318.6.2 Apparatus 318.6.3 Sampling . 318.6.4 Test procedure 328.6.5 Expression of results. 328.6.6 Test report and additional information 328.7 Determination of wall thickness (A).338.7.1 Principle 338.7.2 Apparatus 338.7.3 Sa
45、mpling . 338.7.4 Test procedure 338.7.5 Expression of results. 338.7.6 Test report and additional information 338.8 Determination of suture retention strength (A) 338.8.1 Principle 338.8.2 Apparatus 348.8.3 Sampling . 348.8.4 Test procedure 348.8.5 Expression of results. 348.8.6 Test report and addi
46、tional information 348.9 Determination of kink diameter/radius (A). 358.9.1 Principle 358.9.2 Apparatus 358.9.3 Sampling . 358.9.4 Test procedure 358.9.5 Expression of results. 358.9.6 Test report and additional information 358.10 Determination of dynamic compliance 358.10.1 Principle 358.10.2 Appar
47、atus 358.10.3 Sampling . 368.10.4 Test procedure 368.10.5 Expression of results. 368.10.6 Test report and additional information 379 In vivo preclinical and clinical test methods for vascular prostheses . 379.1 Trial design, data acquisition, and data analysis for in vivo preclinical animal studies
48、. 379.1.1 Principle 379.1.2 Protocol. 379.1.3 Data acquisition 379.1.4 Test report and additional information 389.2 Trial design, data acquisition, and data analysis for clinical evaluation 389.2.1 Principle 389.2.2 Protocol. 389.2.3 Data acquisition 389.2.4 Test report.4110 Information to be record
49、ed and disclosed by the manufacturer on request. 4110.1 General 4110.2 Conformity to general requirements (see clause 4) 4110.3 Conformity to requirements for finished product (see clause 5) 4210.4 Conformity to requirements for in vivo testing and clinical evaluation (see clause 6) . 42Table1 Suggested appropriate tests 8Figures1 Water permeability testerSample holding device (example 1) . 172 Water permeability testerSample holding device (example 2) . 173 Water permeability testerSample holding device (example 3)Bottom assembly 184 Split bar tester 215 Load/extension curve .
