1、ANSI/AAMI/ISO 5840-3: 2013Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniquesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an
2、AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application
3、of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided
4、 that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and th
5、e measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance
6、 characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test me
7、thods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the
8、 reasons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will
9、help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarl
10、y, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide
11、 guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial prac
12、tices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government r
13、egulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals
14、 and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or reco
15、mmended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible
16、 decision-making. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the
17、 specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedu
18、res and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to iden
19、tify a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyz
20、ed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly
21、 useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be m
22、ade in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the A
23、ssociation only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recomm
24、ended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI/ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part
25、 3: Heart valve substitutes implanted by transcatheter techniques Approved 23 November 2012 by Association for the Advancement of Medical Instrumentation Approved 4 December 2012 by American National Standards Institute Abstract: Outlines an approach for verifying/validating the design and manufactu
26、re of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve s
27、ubstitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. Keywords: design, hydrodynamic, material, performance, preclinical, risk, verification, structural AAMI Standard This
28、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 have approved the standard or not, from manufacturing
29、, 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 revised or withdrawn at any time. AAMI procedures requi
30、re that action 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 writing AAMI, or by visiting the AAMI website at HUwww.aami.orgUH. All AAMI standards, reco
31、mmended 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 government
32、 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 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 HUwww.aami.orgUH 2013 by t
33、he Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, 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 perm
34、ission of AAMI. 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 Advance
35、ment of Medical 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, complete the reprint request form at HUwww.aami.orgUH or contact AAMI at 4301 N. Fairfax Dr
36、ive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-492-6 Contents Page Glossary of equivalent standards vi Committee representation vii Background . vii Foreword . ix Introduction . x 1 Scope. 1 2 Normative ref
37、erences 1 3 Terms and definitions 3 4 Abbreviations . 11 5 Fundamental requirements . 11 6 Device description . 11 6.1 Intended use . 11 6.2 Design inputs . 12 6.2.1 Operational specifications 12 6.2.2 Performance specifications 13 6.2.3 Implant procedure 15 6.2.4 Packaging, labeling and sterilizati
38、on . 15 6.3 Design outputs . 15 6.4 Design transfer (manufacturing verification/validation) 15 6.5 Risk management 15 7 Design verification testing and analysis/design validation . 16 7.1 General requirements 16 7.2 In vitro assessment 16 7.2.1 Test conditions, sample selection and reporting require
39、ments . 16 7.2.2 Material property assessment 17 7.2.3 Device hydrodynamic performance assessment . 18 7.2.4 Structural performance assessment 20 7.2.5 Additional implant design evaluation requirements 22 7.2.6 Delivery system design evaluation requirements 23 7.2.7 Design-specific testing 24 7.2.8
40、Visibility 25 7.2.9 Simulated use . 25 7.2.10 Human factors/usability assessment . 25 7.3 Preclinical in vivo evaluation 25 7.3.1 Overall requirements . 25 7.3.2 Methods 27 7.3.3 Test report 28 7.4 Clinical investigations . 29 7.4.1 General 29 7.4.2 Statistical considerations . 29 7.4.3 Distribution
41、 of subjects and investigators 30 7.4.4 Sample size . 30 7.4.5 Entry criteria . 30 7.4.6 Duration of the study . 30 7.4.7 Clinical data requirements 31 7.4.8 Clinical investigation report 33 Annexes Annex A (informative) Rationale for the provisions of this part of ISO 5840 35 Annex B (informative)
42、Examples of transcatheter heart valve substitutes, components and delivery systems 38 Annex C (normative) Packaging . 44 Annex D (normative) Product labels, instructions for use and training 45 Annex E (normative) Sterilization . 49 Annex F (informative) Valve description . 50 Annex G (informative)
43、Transcatheter heart valve substitute hazards, associated failure modes and evaluation methods . 52 Annex H (informative) In vitro test guidelines for paediatric devices 57 Annex I (informative) Statistical procedures when using performance criteria 62 Annex J (informative) Examples and definitions o
44、f some physical and material properties of transcatheter heart valve substitutes and their components . 63 Annex K (informative) Examples of standards applicable to testing of materials and components of transcatheter heart valve substitutes . 78 Annex L (informative) Raw and post-conditioning mecha
45、nical properties for support structure materials . 85 Annex M (informative) Corrosion assessment . 87 Annex N (informative) Guidelines for verification of hydrodynamic performance . 90 Annex O (informative) Durability testing . 94 Annex P (informative) Fatigue assessment 96 Annex Q (informative) Pre
46、clinical in vivo evaluation . 103 Annex R (normative) Adverse event classification during clinical investigation . 106 Annex S (informative) Echocardiographic protocol . 112 Bibliography 115 Figures Figure 1 Schematic representation of flow waveform and regurgitant volumes for one cycle 4 Figure 2 S
47、chematic representation of the positive pressure period of an aortic forward flow interval 9 Figure B.1 Example A . 38 Figure B.2 Example B . 39 Figure B.3 Example C . 39 Figure B.4 Example D . 40 Figure B.5 Example E . 40 Figure B.6 Example F . 41 Figure B.7 Example G 41 Figure B.8 Example H . 42 F
48、igure B.9 Example I 42 Figure B.10 Example J . 43 Figure B.11 Example K. 43 Figure J.1 Example DSC graph for single-stage transformation nickel-titanium alloy . 72 Figure J.2 Typical stress-strain curve of superelastic (SE) nitinol indicating various reportable parameters . 74 Figure J.3 Force-diame
49、ter curve of a superelastic (SE) nitinol support structure demonstrating chronic outward force (COF) and radial resistive force (RRF) 76 Figure P.1 Example schematic of a structural component fatigue assessment using a stress-or strain-life approach . 96 Tables Table 1 Heart valve substitute operational environment for left side of heart Adult population . 12 Table 2 Heart valve substitute operational environment for right side of heart Adult population . 13 Table 3 Minimum device performance requirements, aortic . 18 Table 4Minimum d
