1、ANSI/AAMI/ISO 25539-3: 2011Cardiovascular implants Endovascular devices Part 3: Vena cava filtersAmerican 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 a
2、re 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 avoide
4、d. 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 de
5、termine 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, warning
6、s 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; re
7、aching 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
8、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 ef
9、fectively 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 usuall
10、y 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 sub
11、jects 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
12、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 appl
13、ication 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 se
15、nse 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 r
16、evision (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
18、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 volunt
19、ary 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 res
20、ources 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 wit
21、h 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, Sta
22、ndards 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
23、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 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 25539-3:2011 Cardiovascular implants Endovascular devices Part 3: Vena cava filters Approved 30 November 2011 by
25、 Association for the Advancement of Medical Instrumentation Approved 5 June 2012 by American National Standards Institute Abstract: Specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attrib
26、utes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. Keywords: clinical, delivery, desi
27、gn, dilator, evaluation, IVC, materials, performance, reporting, sampling, sheath AAMI Standard This 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 n
28、ot 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 review, and users are cautioned to obtain the latest editio
29、ns. 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. Interested parties may obtain current information on all AAMI standards by c
30、alling 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 their application is solely within the discretion and professional judgment o
31、f 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 of Medical Ins
32、trumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2012 by the 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 dist
33、ributed 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 inte
34、rnally 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 document
35、, 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 1-57020-443-8 Contents Page Glossary of equivalent standards v Committee Repre
36、sentation . vii Background of ANSI/AAMI adoption of ISO 25539-3:2011 viii Foreword . ix Introduction . x 1 Scope. 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements 5 4.1 Classification 5 4.2 Size 5 5 Intended performance . 5 6 Design attributes 5 6.1 General 5 6.2 Sheath/di
37、lator kit for endovascular filter system . 5 6.3 Filter system . 6 6.4 Filter. 6 6.5 Optional filter 6 6.6 Sheath/dilator kit for endovascular retrieval/conversion system . 6 6.7 Retrieval/conversion system 7 6.8 Endovascular systems 7 7 Materials 7 8 Design evaluation 7 8.1 General 7 8.2 Sampling .
38、 8 8.3 Conditioning of test samples 8 8.4 Reporting 8 8.5 Bench and analytical tests 9 8.6 Preclinical in vivo evaluation 25 8.7 Clinical evaluation 29 9 Post-market surveillance 34 10 Manufacturing 34 11 Sterilization . 34 11.1 Products supplied sterile 34 11.2 Products supplied non-sterile 35 11.3
39、 Sterilization residuals 35 12 Packaging . 35 12.1 Protection from damage in storage and transport . 35 12.2 Marking . 36 12.3 Information supplied by the manufacturer 37 Annex A (informative) Attributes of endovascular devices Vena cava filters Technical and clinical considerations . 39 Annex B (in
40、formative) Descriptions of potential device effects of failure and failure modes and descriptions of detrimental clinical effects . 53 Annex C (informative) Bench and analytical tests . 58 Annex D (informative) Test methods . 62 Annex E (informative) Examples of terms for clinical use of vena cava f
41、ilters . 92 Bibliography 94 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 25539-3:2011 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Sta
42、ndard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officiall
43、y reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list sho
44、uld not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/(R)2012 and ANSI/AAMI ES60601-1:2005/A2:2010/(R)2012 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) Major technical variations C1 Identica
45、l to Corrigendum 1 sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter; delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter; optional filters that ca
46、n be retrieved or converted, and permanent filters together with their associated endovascular systems. While this part of ISO 25539 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. The followin
47、g are outside the scope of this part of ISO 25539: temporary filters (e.g. tethered) that need to be removed after a defined period of time; coatings, surface modifications, and/or drugs; issues associated with viable tissues and non-viable biological materials; degradation and other time-dependent
48、aspects of absorbable materials; procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For
49、 undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993 (all parts), Biological evaluation of medical devices 2 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 25539-3:2011 ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validat
