1、ANSI/AAMI/ISO 25539-1: 2017Cardiovascular implantsEndovascular devicesPart 1: Endovascular prosthesesAmerican 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 practi
2、ce 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, an
3、d (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 av
4、oided. 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 t
5、o 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, war
6、nings 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 an
9、d 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 us
10、ually 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 stand
12、ard 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
13、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 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 th
15、e 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 a
16、nd 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 provisi
17、ons. 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 potent
18、ial 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 vo
19、luntary 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 appe
23、als 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 25539-1:2017 Cardiovascular implantsEndovascular devicesPart 1: Endovascular prostheses Approved 14 April 20
25、17 by AAMI Approved 25 May 2017 by American National Standards Institute Abstract: Specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based u
26、pon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. Keywords: attachment system, delivery system, design, manufacturing, materials, packaging, performance, sterilization, surveillance AAMI Standard This Associatio
27、n 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, marketin
28、g, 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 require that ac
29、tion be taken to reaffirm, revise, or withdraw this 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
30、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 regulatory agencies or procurement authorities, in which ca
31、se the adopting agency is responsible for enforcement of its rules and regulations. Published by AAMI 4301 N. Fairfax Dr., Suite. 301 Arlington, VA 22203-1633 www.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyri
32、ght 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 U.S.
33、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 $100,000
34、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) 276-0793. Printed in the United States of America ISBN 9
35、78-1-57020-663-4 Contents Page Glossary of equivalent standards iv Committee representation . v Background of AAMI adoption of ISO 25539-1:2017 vi Foreword . vii Introduction . viii 1 Scope 1 2 Normative references 2 3 Terms and definitions 2 4 General requirements for endovascular system . 4 5 Inte
36、nded performance . 6 6 Design attributes . 6 7 Materials . 7 8 Design evaluation 8 9 Post-market surveillance 28 10 Manufacturing 28 11 Sterilization 28 12 Packaging . 29 Annex A (informative) Relationship between testing requirements and device attributes and potential failure modes . 32 Annex B (i
37、nformative) Description of clinical and device effects of failure . 51 Annex C (informative) Bench and analytical tests . 55 Annex D (informative) Test methods . 62 Bibliography . 127 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 25539-1:2017 Glossary of equivalent
38、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, this list gives
39、 the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 25539-1:2017 v Committee representation Association for the Advancement of Medical Instrumentat
40、ion Vascular Prostheses Committee The adoption of ISO 25539-1:2017 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 International Organizati
41、on for Standardization (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 ISO/TC 150/SC
42、 2/WG 3) had the following members: Cochair: Dorothy Abel Patrick Norris Members: Dorothy Abel, FDA/CDRH/ODE/DCD/PVDB Richard Bianco, Fairview Health Services Yolanda Bolanos, Johnson b) aortic arch; c) great vessels; left subclavian; left carotid; innominate (brachiocephalic); d) descending thoraci
43、c aortic; e) thoraco-abdominal aortic; f) abdominal aortic and/or aorto-iliac; infrarenal; juxtarenal; pararenal and paravisceral; g) visceral; renal; superior mesenteric; celiac; h) peripheral; iliac; 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 25539-1:2017 6 intern
44、al iliac; femoral; popliteal; tibial; carotid; i) coronary; j) arterio-venous shunt for vascular access; k) transjugular intrahepatic shunt; l) other vessels to be specified. Anatomical indications (e.g. vessel diameter ranges for treatment of occlusive disease, range of landing zone diameters and l
45、engths for the treatment of aneurysms, maximum angulation) shall be specified. For branched or fenestrated devices, the additional vessels to be treated shall be specified. For endovascular prostheses intended to be used in conjunction with adjunctive procedures (e.g. percutaneous transluminal angio
46、plasty), the adjunctive procedure shall be specified. If an endovascular prostheses may be used in a secondary procedure (e.g. treatment of in-stent restenosis, secondary repair of previously placed endovascular prosthesis with inadequate seal or fixation), the conditions of use shall be specified.
47、4.5 Balloon designation Balloons integral to the endovascular system and balloons intended to achieve adequate apposition of the prosthesis shall be designated by the nominal diameter(s) as a function of the inflation pressure(s) or volume(s), the maximum recommended inflation pressure or volume and
48、 the rated burst pressure (RBP). If a commercially available balloon is recommended for use in the instructions for use (IFU), the balloon shall be designated by the balloon type e.g. percutaneous transluminal angioplasty (PTA), moulding, low-pressure aortic, compliant. 5 Intended performance The re
49、quirements of ISO 14630:2012, Clause 4 shall apply. 6 Design attributes 6.1 General The requirements of ISO 14630:2012, Clause 5 shall apply. General design attributes for endovascular systems are listed in Tables A.3 and A.4 with reference to the nonclinical testing necessary for the evaluation of the design. It is recognised that not all tests identified in a category will be necessary or practical for any given endovascular prosthesis and/or system. The rationale for the selection of tests shall be documented. 2017 Association for the
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