ANSI AAMI 18242-2016 Cardiovascular implants and extracorporeal systems-Centrifugal blood pumps.pdf

1、ANSI/AAMI/ISO 18242: 2016Cardiovascular implants and extracorporeal systemsCentrifugal blood pumpsAmerican 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

2、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, and (

3、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 avoid

4、ed. 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 d

5、etermine 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, warnin

6、gs 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; r

7、eaching 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 e

9、ffectively 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 usual

10、ly 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 su

11、bjects 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 app

13、lication 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 ha

14、s 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 s

15、ense 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

16、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 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 volun

19、tary 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 re

20、sources 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 wi

21、th 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, St

22、andards 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 an

24、d 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 18242:2016 Cardiovascular implants and extracorporeal systemsCentrifugal blood pumps Approved 2 September 2016

25、by AAMI Approved 18 November 2016 by American National Standards Institute Abstract: Specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation.

26、 Keywords: biocompatibility, blood, cell, connectors, flow, packaging, sterility 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 no

27、t 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 edition

28、s. 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 ca

29、lling 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 voluntary, and their application is solely within the discretion and professional judgmen

30、t 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 of its rules and regulations. Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlin

31、gton, VA 22203-1633 Uwww.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This 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 sy

32、stem, 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 internally or externally) without the prior written permissio

33、n 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, complete the reprint request form at HUwww.aami.orgUH o

34、r 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 ISBN 978-1-57020-635-1 Contents Page Glossary of equivalent standards iv Committee representation v Background of AAMI adoption of ISO 1

35、8242:2016 vi Foreword vii Introduction viii 1 Scope. 1 2 Normative references. 1 3 Terms and definitions. 2 4 Requirements 3 5 Tests and measurements to determine compliance with this document 4 6 Information supplied by the manufacturer 7 7 Packaging 9 Bibliography . 10 iv 2017 Association for the

36、Advancement of Medical Instrumentation ANSI/AAMI/ISO 18242:2016 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

37、by AAMI (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 18242:2

38、016 v Committee representation Association for the Advancement of Medical Instrumentation Blood/Gas Exchange Device Committee The adoption of ISO 18242:2016 as an American National Standard was initiated by the AAMI Blood/Gas Exchange Device Committee. The AAMI Blood/Gas Exchange Device Committee al

39、so functions 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

40、the time 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 Ho

41、soi, Terumo 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 represent

42、atives 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 18242:2016 Background of AAMI adoption of ISO 18242:2016 As indicated in the foreword to the m

43、ain body 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 Commit

44、tee (TC) 150 Subcommittee (SC) 2, Cardiovascular implants and extracorporeal systems, to ensure that devices designed to provide continuous flow of blood in support of, or as a substitution for, the normal pumping function of the heart have been adequately tested for both their safety and function,

45、and that extracorporeal device characteristics are appropriately disclosed when labelling 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 for the Advancement of Medical Instrumentation (AAMI). A

46、AMI encourages its committees to harmonize their work with international standards as much as possible. The U.S. adoption of ANSI/AAMI/ISO 18242:2016 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 I

47、SO/TC 150/SC 2/WG 4, Blood/gas exchangers) initiated the U.S. adoption of ISO 18242:2016. 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 o

48、ther ISO standards. See the Glossary of Equivalent Standards for a list of ISO standards adopted by AAMI which gives the corresponding U.S. designation and the level of equivalency with the ISO standard. As used within the context of this document, “shall” indicates requirements strictly to be follo

49、wed to conform to the standard. “Should” indicates that among several possibilities, one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited. “May” is used to indicate that a course of action is permissible within the limits of the standard. “Can” is used as a statement of possibility and capability. Finally, “must” is used only to describe “unavoidable” si