1、ANSI/AAMI/ISO 25539-2: 2012Cardiovascular implants Endovascular devices Part 2: Vascular stents American 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 practice ar
2、e 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 (2)
3、 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 avoided
4、. 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 det
5、ermine 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, warnings
6、 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; rea
7、ching 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 be d
8、ocumented 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 eff
9、ectively 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 usually
10、 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 subj
11、ects 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 standard o
12、r 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 appli
13、cation 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 has
14、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 sen
15、se 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 and re
16、vision (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 provisions.
17、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 potential r
18、isks 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 volunta
19、ry 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 reso
20、urces 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 with
21、 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, Stan
22、dards 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 appeals a
23、nd 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 and
24、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 25539-2:2012 (Revision of ANSI/AAMI/ISO 25539-2:2008) Cardiovascular implants Endovascular devices Part 2: Vascul
25、ar stents Approved 3 December 2012 by Association for the Advancement of Medical Instrumentation Approved 4 December 2012 by American National Standards Institute Abstract: Specifies requirements for vascular stents, based upon current medical knowledge. Gives requirements for intended performance,
26、design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. Includes vascular stents used to treat vascular lesions or stenosis, or other vascular abnormalities. These devices may or may not incorporate surface modifications o
27、f the stent such as drug and/or other coatings. Keywords: balloon, biocompatibility, classification, delivery, design, implant, sampling, sizing, reporting AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concern
28、ed 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 procedures not conforming to the standard. AAMI standards are subje
29、ct 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 this standard no later than 5 years from the date of publication. In
30、terested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and the
31、ir 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 enforcement of its rules an
32、d regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of
33、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 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,
34、 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 $100,000 per off
35、ense. 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 at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57
36、020-480-2 Contents Page Glossary of equivalent standards . v Committee representation. vi Background of ANSI/AAMI adoption of ISO 25539-2:2012 . vii Foreword . viii Introduction ix 1 Scope. 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements 5 4.1 Classification 5 4.2 Size 5
37、4.3 Intended clinical use designation 5 5 Intended performance . 6 6 Design attributes 6 6.1 General 6 6.2 Delivery system and stent system . 7 6.3 Implant. 7 7 Materials 8 8 Design evaluation 8 8.1 General 8 8.2 Sampling . 9 8.3 Conditioning of test samples 9 8.4 Reporting 10 8.5 Delivery system an
38、d stent system . 10 8.6 Stent 17 8.7 Preclinical in vivo evaluation 27 8.8 Clinical evaluation 31 9 Post-market surveillance 36 10 Manufacturing 36 11 Sterilization . 36 11.1 Products supplied sterile 36 11.2 Products supplied non-sterile 36 11.3 Sterilization residuals 36 12 Packaging . 37 12.1 Pro
39、tection from damage in storage and transport . 37 12.2 Marking . 37 12.3 Information supplied by the manufacturer 38 Annex A (informative) Attributes of endovascular devices Vascular stents Technical and clinical consideration . 40 Annex B (informative) Bench and analytical tests . 47 Annex C (infor
40、mative) Definitions of reportable clinical events . 51 Annex D (informative) Test methods . 54 Annex E (informative) Supplement to fatigue durability test analytical approach . 97 Bibliography 100 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 25539-2:2012 v Glossary o
41、f equivalent standards International 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, th
42、is list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 25539-2:2012 Committee representation Association for the Advancement of Medic
43、al Instrumentation Vascular Prostheses Committee The adoption of ISO 25539-2:2012 as an American National Standard was initiated by the AAMI Vascular Prostheses Committee. The AAMI Vascular Prostheses Committee also functions as the U.S. Technical Advisory Group to the relevant work in the Internati
44、onal Organization for Sterilization (ISO). U.S. representatives from the AAMI Vascular Prostheses Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 3) played an active part in developing the ISO standard. At the time this document was published, the AAMI Vascular Prostheses Committee (U.S. Sub-TAG for
45、ISO/TC 150/SC 2/WG 3) had the following members: Cochairs Dorothy Abel Lou Smith Members Dorothy Abel, FDA/CDRH Richard Bianco, University of Minnesota Brian Choules, PhD, Med Institute, Inc. James Conti, PhD, Dynatek Dalta Scientific Instruments Jeff Elkins, Aptus Endosystems Michael Hallisey, MD,
46、Jefferson Radiology Mark Hoekwater, Medtronic Cardiovascular Jason Humphrey, Boston Scientific Martin King, PhD, Hopital Saint Francois DAssise/Quebec Biomaterials Institute Evan Lipsitz, MD, Montefiore Medical Center Lito Mejia, Bose Corporation Keith Morel, DEKRA Ning Pan, Johnson 1) self-expandin
47、g: i) unconstrained external diameter of the device, expressed in millimeters; ii) intended vessel lumen diameter range, expressed in millimeters; 2) balloon expandable: range of intended expanded internal diameters; b) minimum and maximum usable length, expressed in millimeters or centimeters. 4.3
48、Intended clinical use designation The intended clinical use shall be designated by one or more of the following: a) abdominal aorta; b) arterio-venous shunt for vascular access; c) carotid; d) coronary; e) femoral; f) iliac; 6 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI
49、/ISO 25539-2:2012 g) popliteal; h) renal; i) thoracic aorta; j) thoraco-abdominal aorta; k) tibial; l) other arterial vessels to be specified; m) other venous vessels to be specified. 5 Intended performance The requirements for intended performance specified in ISO 14630:2012, Clause 4, shall apply. 6 Design attributes 6.1 General The requirements for design attributes of ISO 14630:2012, Clause 5, apply. In addition, the following shall be taken into account: a) oxidation-potential, the possibility of crevice corrosion, passivation over the relevant parts; b) fret
