1、ANSI/AAMI/ISO 11658:2012Cardiovascular implants and extracorporeal systems Blood/tissue contact surface modifications for extracorporeal perfusion systemsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential u
2、ses of an AAMI product standard 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 ap
3、plication of current technologies 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 an
4、d provided that arbitrary and 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 u
5、se, and the measurement techniques 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 p
6、erformance characteristics, instructions 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 specializ
7、ed test methods to facilitate 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 provid
8、ed and the reasons for establishing 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
9、that will help ensure that a device 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
10、. Similarly, even though a recommended 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 criteri
11、a, provide guidelines to industrial 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 indus
12、trial practices. In determining 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 go
13、vernment regulatory or procurement 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 pro
14、fessionals and industrial representatives, 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 standa
15、rd or recommended practice is 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 r
16、esponsible decision-making. Despite 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 develop
17、ed and the specific rationale 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 curre
18、nt procedures and practices. While 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 ser
19、ve to identify a particular product 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
20、 be analyzed in the context of 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 practic
21、e is truly useful only when it 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
22、 must be made in writing, to the 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 representatio
23、n of the Association only upon 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
24、 or recommended practice which 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 11658:2012 Cardiovascular implants and extracorporeal s
25、ystems Blood/tissue contact surface modifications for extracorporeal perfusion systems Approved 20 July 2012 by Association for the Advancement of Medical Instrumentation Approved 20 August 2012 by American National Standards Institute Abstract: This standard will apply to components of heart-lung b
26、ypass equipment and of extracorporeal life support equipment that carry blood and have a coating on the blood contact surface of the device. While standards exist for the main components used in heart-lung bypass and extracorporeal life support equipment, many of these components are currently distr
27、ibuted with a surface coating that comes in contact with blood. This aspect of the design of these components was not addressed in the existing standard. Rather than rewrite the existing standards, a single standard will address the composition, the mechanical and biological characteristics, perform
28、ance and safety of these coating for all the components. Keywords: bioactivity, biocompatibility, biological, coverage, integrity, leaching, nonpyrogenicity, sterile AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantial
29、ly 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 procedures not conforming to the standard. AAMI standards
30、 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 this standard no later than 5 years from the date of publi
31、cation. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at HUwww.aami.orgUH. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are volu
32、ntary, 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 enforcement o
33、f its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 HUwww.aami.orgUH 2012 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to co
34、pyright claims of 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 l
35、aw (17 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 o
36、f $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at HUwww.aami.orgUH 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 State
37、s of America ISBN 1-57020-451-9 Contents Page Glossary of equivalent standards . iv Committee Representation . vii Background of ANSI/AAMI adoption of ISO 11658:2012 viii Foreword . ix Introduction . x 1 Scope. 1 2 Normative references 1 3 Terms and definitions 2 4 Requirements . 2 4.1 Biological ch
38、aracteristics . 2 4.2 Physical characteristics 3 4.3 Performance characteristics . 3 5 Tests 3 5.1 General 3 5.2 Biological characteristics . 4 5.3 Physical characteristics 4 5.4 Performance characteristics . 5 6 Information supplied by the manufacturer 6 6.1 General 6 6.2 Information to be given in
39、 the accompanying documents 6 Bibliography 7 iv 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11658:2012 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each I
40、nternational Standard 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 docume
41、nt was officially 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; therefor
42、e, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005/(R)2012 Major technical variations IEC 60601-1:2005/A1:2012 ANSI/AAMI ES60601-1:2005/A1:2012 A1 identical IEC Technical Corrigendum 1 and 2 ANSI/AAMI ES6
43、0601-1:2005/C1:2009/(R)2012 (amdt) C1 identical to Corrigendum 1 for reservoirs, ISO 15674; for arterial filters, ISO 15675; for tubing packs, ISO 15676. For devices with a surface modification, the additional information specified in 6.2 shall be provided. 6.2 Information to be given in the accompa
44、nying documents Each shipping container shall contain an “Instructions for Use” leaflet with the following information. a) Coverage: a statement indicating the extent to which the modification effectively covers the blood- or tissue-contacting surface of the device. If such a modification is not pre
45、sent on all blood- or tissue-contacting surfaces of the device, a clear description shall be provided of what components are and are not modified. b) Leaching: if changes in the modification during use or elution of the modification have adverse clinical effects, they should be described. c) Bioacti
46、vity (if there is a claim of bioactivity for the modification): a statement quantifying the manufacturers specification for any biological activity that the modification will impart to the blood or tissues to which it is exposed. d) A statement that the test methods used to determine coverage, leach
47、ing and bioactivity (if applicable) are available upon request. 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11658:2012 7 Bibliography 1 ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes 2 ISO 14971, Medical devices Applicatio
48、n of risk management to medical devices 3 ANDERSSON, J. et al. Optimal heparin surface concentration and antithrombin binding capacity as evaluated with human non-anticoagulated blood in vitro. J Biomed Mater Res 2003;67A:458-466 4 BELWAY, D. et al. Currently available biomaterials for use in cardio
49、pulmonary bypass. Expert Rev Med Device 2006;3:345-355 5 BELZER, R. et al. Activation of blood coagulation at heparin-coated surfaces. J Biomed Mater Res 1997;37:108-113 6 CORNELIUS, R.M. et al. Interactions of antithrombin and proteins in the plasma contact activation system with immobilized functional heparin. J Biomed Mater Res 2003;67A:475-483 7 ELGUE, G. et al. Effect of surface-immobilized heparin on the activation of adsorbed factor XII. Artif Organs 1993;17:721-726 8 ELGUE, G. et al. On the mechanism of coagulation inhibition on surfaces
