1、ANSI/AAMI/ISO 15674: 2016Cardiovascular implants and artificial organs Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bagsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives
2、 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 increase in the safe
3、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 attention to the
4、se 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 qualifying the devic
5、e 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 provided with the dev
6、ice, 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 necessitates the developm
7、ent 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 criteria, referee test
8、s 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 rather procedure
9、s 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 reference for d
10、evice 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 addressing device per
11、formance 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 professionals in und
12、erstanding 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 course, they a
13、re 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 a committee of
14、 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 ensure patient
15、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, but it should
16、 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 document was i
17、nitially 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 a recommended p
18、ractice 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 source of info
19、rmation 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, a recommended
20、 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 standard or rec
21、ommended 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 standards and recom
22、mended 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 become official a
23、nd 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 characterization or explanati
24、on 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 15674:2016 Cardiovascular implants and
25、artificial organs Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags Approved 2 September 2016 by AAMI Approved 18 November 2016 by American National Standards Institute Abstract: Specifies requirements for sterile, single-use, extracorporeal hard-she
26、ll cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery. Keywords: biocompatibility, connectors, pyrogenicity, sterility AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI
27、) 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, or using products, processes, or proced
28、ures 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 reaffirm, revise, or withdraw this st
29、andard 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, technical information reports, and other type
30、s 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 case t
31、he 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 This publication is subject to copyrigh
32、t 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.C.
33、 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 pe
34、r 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. Printed in the United States of America
35、ISBN 978-1-57020-636-8 Contents Page Glossary of equivalent standards iv Committee representation v Background of AAMI adoption of ISO 15674:2016 vi Foreword vii 1 Scope. 1 2 Normative references. 1 3 Terms and definitions. 1 4 Requirements 3 4.1 Biological characteristics 3 4.2 Physical characteris
36、tics 4 4.3 Performance characteristics . 4 5 Tests and measurements to determine compliance with this document 5 5.1 General . 5 5.2 Biological characteristics 5 5.3 Physical characteristics 6 6 Information supplied by the manufacturer 7 6.1 Information on the reservoir (labelling) . 7 6.2 Informati
37、on on the packaging . 8 6.3 Information in the accompanying documents . 8 6.4 Information in the accompanying documents in a prominent form 9 7 Packaging 9 Annex A (normative) Factors to be considered in evaluating performance characteristics . 10 Bibliography . 11 iv 2017 Association for the Advanc
38、ement of Medical Instrumentation ANSI/AAMI/ISO 15674:2016 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 AAM
39、I (and ANSI). Available 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/ISO 15674:2016 v
40、Committee representation Association for the Advancement of Medical Instrumentation Blood/Gas Exchange Device Committee The adoption of ISO 15674:2016 as an American National Standard was initiated by the AAMI Blood/Gas Exchange Device Committee. The AAMI Blood/Gas Exchange Device Committee also fun
41、ctions as the U.S. Technical 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 ti
42、me this document was published, 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, T
43、erumo Cardiovascular Systems 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
44、 in the development of 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/ISO 15674:2016 Background of AAMI adoption of ISO 15674:2016 As indicated in the foreword to the main bo
45、dy of this document (page 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 (T
46、C) 150 Subcommittee (SC) 2, Cardiovascular implants and extracorporeal systems, to ensure that devices, either hard-shell or soft bag, designed to be used as reservoirs for the collection, filtration, and defoaming of venous and/or cardiotomy-suctioned blood during extracorporeal circulation, have b
47、een adequately tested for both safety and function, and, additionally, that the device characteristics are appropriately disclosed when labeling the device. 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 f
48、or the Advancement of Medical Instrumentation (AAMI). AAMI encourages its committees to harmonize their work with international standards as much as possible. The U.S. adoption of ANSI/AAMI/ISO 15674:2016 was approved by the American National Standards Institute (ANSI) on 18 November 2016. The AAMI
49、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 15674:2016. Compared to ANSI/AAMI/ISO 15674:2009, which is now superseded, ANSI/AAMI/ISO 15674:2016 provides additional guidance on reference documents and clarification of definitions and labelling requirements. 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
