1、ANSI/AAMI/ISO 15676: 2016Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)American National StandardObjectives and uses of AAMI standards and recommended practices It is most important that
2、 the objectives and potential uses 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 increa
3、se in the safe and effective application 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 a
4、ttention to these objectives and 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 quali
5、fying the device for clinical use, 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 provid
6、ed with the device, including performance 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 necessitat
7、es the development of specialized 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 criteri
8、a, referee tests must be provided 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 r
9、ather procedures and practices 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
10、reference for device evaluation. 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 addres
11、sing device performance criteria, 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 profe
12、ssionals in understanding industrial 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
13、 course, they are adopted by government 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
14、 a committee of health care professionals 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
15、ensure patient safety. A standard 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
16、, but it should never replace responsible 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
17、 document was initially developed 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
18、a recommended practice to current 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
19、 source of information will serve 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
20、, a recommended practice should 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
21、standard or recommended practice 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 stan
22、dards and recommended practices 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 be
23、come official and representation 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 characterizati
24、on or explanation of a standard 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 15676:2016 Cardiovascula
25、r implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) Approved 2 September 2016 by AAMI Approved 18 November 2016 by American National Standards Institute Abstract: Specifies requirements for single-use tub
26、ing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). Applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with perista
27、ltic pumps during (short-term, i.e. 24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”. Keywords: biocompatibility, connections, filtration, flow, pyrogenicity, sterility AAMI Standard This Association for the Advanc
28、ement 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, marketing, purchasing, o
29、r 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 action be taken to
30、 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 calling or writing AAMI, or by visiting the AAMI website at HUwww.aami.orgUH. All AAMI standards, recommended practices, technic
31、al information reports, and other 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 pr
32、ocurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 Uwww.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved T
33、his publication is subject to copyright 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 i
34、s illegal under federal law (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
35、 penalties, and damages of $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: +1-703-276-0793. Pr
36、inted in the United States of America ISBN 978-1-57020-638-2 Contents Page Glossary of equivalent standards iv Committee representation . v Background of AAMI adoption of ISO 15676:2016 . vi Foreword . vii Introduction . viii 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Requirement
37、s . 3 4.1 Biological characteristics 3 4.2 Physical characteristics 3 4.3 Performance characteristics . 4 5 Tests and measurements 4 5.1 General . 4 5.2 Biological characteristics 4 5.3 Physical characteristics 5 5.4 Performance characteristics . 5 6 Information supplied by the manufacturer 6 6.1 In
38、formation on the tubing pack . 6 6.2 Information on the accompanying documents 7 6.3 Information in the accompanying documents in a prominent form 7 6.4 Information to be provided by manufacturer upon request . 7 7 Packaging . 8 Bibliography . 9 iv 2017 Association for the Advancement of Medical Ins
39、trumentation ANSI/AAMI/SO 15676:2016 Glossary of 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). Availab
40、le 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/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 15676:2016 v Committee representati
41、on Association for the Advancement of Medical Instrumentation Blood/Gas Exchange Device Committee The adoption of ISO 15676:2016 as an American National Standard was initiated by the AAMI Blood/Gas Exchange Device Committee. The AAMI Blood/Gas Exchange Device Committee also functions as the U.S. Tec
42、hnical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Blood/Gas Exchange Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4) played an active part in developing the ISO standard. At the time this document was p
43、ublished, the AAMI Blood/Gas Exchange Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4) had the following members: Cochairs: Trevor Huang, PhD MBA Mark Kurusz, CCP Members: Richard Chan, CCP, Northshore University Hospital Drew Holmes, Baxter Healthcare Tsuyoshi Hosoi, Terumo Cardiovascular S
44、ystems Trevor Huang, PhD MBA, Medtronic Perfusion Systems George Silvay, MD PhD, Mount Sinai Medical Center Catherine Wentz, FDA/CDRH Alternates: David M. Fallen, CCP, Terumo Medical Qijin Lu, FDA/CDRH Rakesh Sethi, Medtronic NOTE Participation by federal agency representatives in the development of
45、 this standard does not constitute endorsement by the federal government or any of its agencies. vi 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 15676:2016 Background of AAMI adoption of ISO 15676:2016 As indicated in the foreword to the main body of this document (pa
46、ge vii), the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The United States is one of the ISO members that took an active role in the development of this standard, which was developed by ISO Technical Committee (TC) 150 Subcommittee (SC
47、) 2, Cardiovascular implants and extracorporeal systems, to ensure that medical grade tubing in single-use tubing packs for the transfer of blood and fluid during the period of cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) is adequately tested for both safety and functi
48、on. U.S. participation in this ISO SC is organized through the U.S. Technical Advisory Group for ISO/TC 150/SC 2, administered by the Association for the Advancement of Medical Instrumentation (AAMI). AAMI encourages its committees to harmonize their work with international standards as much as poss
49、ible. The U.S. adoption of ANSI/AAMI/ISO 15676:2016 was approved by the American National Standards Institute (ANSI) on 18 November 2016. The AAMI Blood/Gas Exchange Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4, Blood/gas exchangers) initiated the U.S. adoption of ISO 15676:2016. AAMI and ANSI procedures require that standards be reviewed and, if necessary, revised every five years to reflect technological advances that may have occurred since publication. AAMI (and ANSI) have adopted other ISO standards. See the Glossary of Equivalent Standards for a list of IS
