ANSI AAMI 5840-1-2015 Cardiovascular implants-Cardiac valve prostheses-Part 1 General requirements.pdf

1、ANSI/AAMI/ISO 5840-1:2015Cardiovascular implantsCardiac valve prosthesesPart 1: General requirementsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended practic

2、e 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 technologies to patient care, and

3、 (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 restrictive uses are avo

4、ided. 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 techniques that can be used to

5、 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, instructions for use, warn

6、ings 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 uniformity in reporting;

7、 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 establishing the criteria must

8、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 device is used safely and

9、 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 recommended practice is usu

10、ally 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 industrial personnel on such

11、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 determining whether an AAMI standa

12、rd 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 procurement authorities). The a

13、pplication 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 representatives, whose work

14、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 limited, however, in the

15、 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. Despite periodic review an

16、d 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 for each of its provisio

17、ns. 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. While observed or potenti

18、al 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 product as “unsafe“. A vol

19、untary 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 the specific needs and

20、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 is used in conjunction

21、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 the AAMI Vice President,

22、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 exhaustion of any appea

23、ls 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 has not been developed

24、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 5840-1:2015 Cardiovascular implantsCardiac valve prostheses Part 1: General requirements Developed by Associa

25、tion 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 heart valve substitute through risk management. The selection of appropriate qualification tests

26、and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical eva

27、luation of the finished heart valve substitute. Keywords: clinical, design, implant, input, mechanical, operation, output, performance, risk AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its sco

28、pe 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 procedures not conforming to the standard. AAMI standards are subject to periodic

29、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 this standard no later than five years from the date of publication. Interested par

30、ties 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 voluntary, and their application is solely within the discretion and profession

31、al 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 enforcement of its rules and regulations. Published by Association for the Advancement o

32、f 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 copyright claims of ISO and AAMI. No part of this publication may be reproduced or

33、 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 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether

34、 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 $100,000 per offense. For permission regarding the use of all or any part of this doc

35、ument, 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 ISBN 1-57020-599-X Contents Page Glossary of equivalent standards iv Committee rep

36、resentation v Background on AAMI adoption of ISO 5840-1:2015 . vi Foreword vii Introduction viii 1 Scope. 1 2 Normative references. 1 3 Terms and definitions. 2 4 Abbreviations . 12 5 Fundamental requirements 12 6 Device description . 12 6.1 Intended use 12 6.2 Design inputs . 12 6.2.1 Operational s

37、pecifications . 12 6.2.2 Performance specifications . 13 6.2.3 Implant procedure . 13 6.2.4 Packaging, labelling, and sterilization 13 6.3 Design outputs . 14 6.4 Design transfer (manufacturing verification/validation) 14 6.5 Risk management 15 7 Design verification testing and analysis/design valid

38、ation 15 7.1 General requirements 15 7.2 In vitro assessment 15 7.3 Preclinical in vivo evaluation 15 7.4 Clinical investigations 15 Annex A (informative) Rationale for the provisions of this part of ISO 5480 16 Annex B (normative) Packaging 19 Annex C (normative) Product labels, instructions for us

39、e, and training . 20 Annex D (normative) Sterilization 23 Annex E (informative) In vitro test guidelines for pediatric devices . 24 Annex F (informative) Statistical procedures when using in vitro performance criteria . 29 Annex G (informative) Examples and definitions of some physical and material

40、properties of heart valve systems 30 Annex H (informative) Examples of standards applicable to testing of materials and components of heart valve systems 41 Annex I (informative) Raw and post-conditioning mechanical properties for support structure materials 47 Annex J (informative) Corrosion assess

41、ment 49 Annex K (informative) Echocardiographic protocol . 52 Bibliography . 55 iv 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5840-2:2015 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other

42、 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.S. designation and level of equivalency to the International Standard. www.aami.org

43、/standards/glossary.pdf 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5840-2:2015 v Committee representation Association for the Advancement of Medical Instrumentation Cardiac Valve Committee The adoption of ISO 5840-1:2015 as an American National Standard was initiat

44、ed 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. representatives from the AAMI Cardiac Valve Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 1

45、 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 Members: Devesh Amatya, PhD, Colibri Heart Valve Richard W. Bianco, University of Minne

46、sota 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 Center Danny Dvir, MD, Providence Health Care Robert W.M. Frater, MD, Bronxville, NY Xi

47、ao-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 Sal

48、vador Marquez, Edwards LifeSciences David Mester, W.L. Gore p1 is the diastolic pressure, in mmHg; p2 is the systolic pressure, in mmHg; r1 is the inner radius at p1, in millimetres; r2 is the inner radius at p2, in millimetres. Note 1 to entry: Reference ISO 25539-1. 4 2015 Association for the Adva

49、ncement of Medical Instrumentation ANSI/AAMI/ISO 5840-2:2015 Key X time Y flowrate 1 closing volume 2 leakage volume Figure 1 Schematic representation of flow waveform and regurgitant volumes for one cycle 3.13 component-joining material material such as a suture, adhesive, or welding compound used to assemble the components of a heart valve system (3.29) 3.14 cumulative incidence statistical technique where events other than death can be described by the occurrence of the event over time without including death of the subjects Note 1 to entry: Cumulative incidence is