1、ANSI/AAMI/ISO 5840-2:2015Cardiovascular implantsCardiac valve prosthesesPart 2: Surgically implanted heart valve substitutesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standar
2、d 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 of current technolog
3、ies 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 that arbitrary and
4、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 the measurement techni
5、ques 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 characteristics, in
6、structions 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 methods to facilitate
7、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 reasons for establi
8、shing 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 help ensure that a d
9、evice 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. Similarly, even though a rec
10、ommended 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 guidelines to indus
11、trial 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 practices. In determinin
12、g 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 regulatory or procure
13、ment 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 and industrial repr
14、esentatives, 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 recommended practice is
15、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 decision-making. De
16、spite 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 specific rationale
17、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 procedures and practices. W
18、hile 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 identify a particular pr
19、oduct 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 analyzed in the context of
20、 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 useful only when it
21、 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 made in writing, to t
22、he 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 Association only upon
23、 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 recommended practice which
24、 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 5840-2:2015 Cardiovascular implantsCardiac valve prostheses Part 2: Surgically implan
25、ted heart valve substitutes Developed by Association for the Advancement of Medical Instrumentation Approved 16 November 2015 by American National Standards Institute, Inc. Abstract: Outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk mana
26、gement. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also
27、 include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. Keywords: assessment, clinical, design, input, operational, output, performance, risk, test, use AAMI Standard This Association for the Advancement of Medical Instrumentation (
28、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, marketing, purchasing, or using products, processes, or pr
29、ocedures 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 require that action be taken to reaffirm, revise, or withdraw thi
30、s 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, recommended practices, technical information reports, and other types of technical documents developed by AAMI are
31、 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 regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcem
32、ent of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite. 301 Arlington, VA 22203-1633 www.aami.org 2015 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to co
33、pyright claims of ISO 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. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17
34、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 Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,
35、000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America IS
36、BN 1-57020-600-7 Contents PageGlossary of equivalent standards . v Committee representation . vi Background on AAMI adoption of ISO 5840-2:2015 vii Foreword viii Introduction . ix 1 Scope. 1 2 Normative references. 1 3 Terms and definitions. 2 4 Abbreviations . 4 5 Fundamental requirements 5 6 Devic
37、e description . 5 6.1 Intended use 5 6.2 Design inputs . 5 6.2.1 Operational specifications . 5 6.2.2 Performance specifications . 5 6.2.3 Packaging, labelling, and sterilization 6 6.3 Design outputs . 6 6.3.1 General . 6 6.4 Design transfer (manufacturing qualification) 6 6.5 Risk management 6 7 De
38、sign verification testing and analysis/design validation 6 7.1 General requirements 6 7.2 In vitro assessment 7 7.2.1 Test conditions, sample selection, and reporting requirements . 7 7.2.2 Material property assessment . 8 7.2.3 Hydrodynamic performance assessment 8 7.2.4 Structural performance asse
39、ssment 10 7.2.5 Device MRI safety . 11 7.2.6 Additional implant design evaluation requirements . 11 7.2.7 Design specific testing . 11 7.2.8 Simulated use . 12 7.2.9 Human factors/usability assessment . 12 7.3 Preclinical in vivo evaluation 12 7.3.1 Overall requirements . 12 7.3.2 Methods 13 7.3.3 T
40、est report . 14 7.4 Clinical investigation 14 7.4.1 General . 14 7.4.2 Statistical considerations . 15 7.4.3 Distribution of subjects and investigators 15 7.4.4 Sample size . 15 7.4.5 Entry criteria 15 7.4.6 Duration of the study . 16 7.4.7 Clinical data requirements . 16 7.4.8 Clinical investigatio
41、n report . 18 Annex A (informative) Heart valve substitute hazards, associated failure modes, and evaluation methods . 20 Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers 23 Annex C (informative) Preclinical in vivo evaluation 25 Annex D (inform
42、ative) Description of the surgical heart valve substitute . 28 Annex E (informative) Examples of components of some surgical heart valve substitutes . 30 Annex F (informative) Guidelines for verification of hydrodynamic performance. 34 Annex G (informative) Durability testing 43 Annex H (informative
43、) Examples of design specific testing . 45 Annex I (informative) Fatigue assessment 47 Annex J (normative) Methods of evaluating clinical data 53 Bibliography . 54 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5840-2:2015 v Glossary of equivalent standards Internation
44、al Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.
45、S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf vi 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5840-2:2015 Committee representation Association for the Advancement of Medical Instrumentation Cardiac Valve Co
46、mmittee The adoption of ISO 5840-2:2015 as an American National Standard was initiated by the AAMI Cardiac Valve Committee. The AAMI Cardiac Valve Committee also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Sterilization (ISO). U.S. represen
47、tatives from the AAMI Cardiac Valve Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 1, Cardiac valves) played an active part in developing the ISO standard. At the time this document was published, the AAMI Cardiac Valve Committee had the following members: Cochairs: Ann M. Graves Changfu Wu, PhD Mem
48、bers: Devesh Amatya, PhD, Colibri Heart Valve Richard W. Bianco, University of Minnesota Jeffrey Borer, MD, Weill Cornell Medical College of Cornell University James C. Conti, PhD, Dynatek Labs Joanna Develter, Abbott Vascular Structural Heart Francis Duhay, MD, Univ of California Irvine Medical Cen
49、ter Danny Dvir, MD, Providence Health Care Robert W.M. Frater, MD, Bronxville, NY Xiao-Yan Gong, PhD, Medical Implant Mechanics Ann M. Graves, St. Jude Medical Rebecca Tung Hahn, MD, Columbia University Presbyterian Hospital Stephen Hilbert, PhD MD, Childrens Mercy Hospital/ Ward Family Center for Congenital Heart Disease George Gilbert Johnston, MD FACS, US Department of State Salvador Marquez, Edwards LifeSciences David Mester, W.L. Gore ability to prevent retrograde flow with acceptably small regurgitation; ability to resist embolization; ability to resist hemolysi
