ANSI BF7-2012 Blood transfusion microfilters《输血过滤器》.pdf

1、ANSI/AAMIBF7:2012Blood transfusion microfiltersAmerican 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 are clearly understood. The objectives of AAMIs tec

2、hnical 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) the encouragement of new technologies. It is AAM

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24、d which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI BF7:2012 (Revision of ANSI/AAMI BF7:1989/(R)2011) Blood transfusion microfilters Developed by Association for the Advancement of Medical Instrumentation Approved 30 N

25、ovember 2012 by American National Standards Institute, Inc. Abstract: This standard contains labeling requirements, performance requirements, test methods, and terminology for disposable blood transfusion microfilters for use with adult populations to remove microaggregates from blood or blood produ

26、cts during transfusion. . Keywords: blood, capacity, flow, interface, labeling, performance, volume 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 AA

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29、AMI 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 voluntary, and their application is solely within the discretion and p

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31、ncement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 HUwww.aami.orgUH 2013 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

32、 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. 101, et seq.) to make copies of all or any part of t

33、his 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 per offense. For permission regarding the use of all or

34、 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 States of America ISBN 1570204861 Contents Page Glossary of equivalent

35、standards . v Committee representation . vi Foreword vii 1 Scope 1 1.1 General 1 1.2 Inclusions . 1 1.3 Exclusions 1 2 Normative references . 1 3 Definitions . 2 4 Requirements . 3 4.1 Labeling . 3 4.1.1 General 3 4.1.2 Primary package labeling 3 4.1.3 Instructions for use 3 4.1.4 Disclosure informa

36、tion . 4 4.2 Performance 4 4.2.1 Packaging 4 4.2.2 Filter device characteristics . 4 4.2.3 Device materials 5 4.2.4 Covers of the inflow and outflow connector portions . 5 4.2.5 Structural integrity 5 4.2.6 Filter performance . 5 4.3 Interface characteristics . 6 4.3.1 Filters without attached admin

37、istration sets . 6 4.3.2 Filters with attached administration sets 6 4.4 Material safety 7 4.4.1 Evaluation of potential toxicity . 7 4.4.2 Sterility . 7 4.4.3 Pyrogenicity . 7 4.4.4 Compatibility with blood . 7 4.4.5 Complement activation 7 4.4.6 Leachable substances . 7 5 Tests . 7 5.1 Labeling .

38、7 5.1.1 Disclosure information . 7 5.2 Performance requirements 8 5.2.1 Packaging 8 5.2.2 Structural integrity 8 5.2.3 Filter performance . 8 5.3 Interface characteristics . 8 5.3.1 Filters without attached administration sets . 11 5.3.2 Filters with attached administration sets 12 5.4 Material safe

39、ty 12 5.4.1 Evaluation of potential toxicity . 12 5.4.2 Sterility . 14 5.4.3 Pyrogenicity . 14 5.4.4 Compatibility with blood . 14 Annexes A Rationale for the development and provisions of this standard 15 B Bibliography 19 Tables 1 Scoring intracutaneous irritation injections . 13 2 Calculating the

40、 threshold irritant calculation . 14 3 Scoring degree of erythema after 24 hours 14 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI BF7:2012 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other Int

41、ernational Standards. AAMI maintains a current list of each International Standard that has been adopted 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/sta

42、ndards/glossary.pdf vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI BF7:2012 Committee representation Association for the Advancement of Medical Instrumentation Blood Filter Committee This standard was developed by the AAMI Blood Filter Committee. Committee approval of t

43、he standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Blood Filter Committee had the following members: Cochairs: David Louis Reich, MD Donald Sherratt Members: Phillip Bendick, Beaumont Services Company LLC Dawn D

44、esiderio, MD, Memorial Sloan Kettering Cancer Center Trevor C. Huang, PhD MBA, Medtronic Perfusion Systems Melissa S. Pessin, MD PhD, Memorial Sloan Kettering Cancer Center Betsy Poindexter, U.S. Food and Drug Administration/Center for Biologics Evaluation and Research David Louis Reich, MD, Mount S

45、inai School of Medicine Donald Sherratt, Terumo BCT, Inc. George Silvay, MD, PhD, Mount Sinai Medical Center Ralph Slepian, MD, New York Presbyterian Hospital Catherine Wentz, US Food and Drug Administration/Center for Devices and Radiological Health Alternates: Lauren Clark, Terumo BCT Jaroslav G.

46、Vostal, MD, PhD, U.S. Food and Drug Administration/Center for Biologics Evaluation and Research NOTEParticipation by federal agency representatives in the development of this standard does not constitute endorsement by the federal government or any of its agencies. 2013 Association for the Advanceme

47、nt of Medical Instrumentation ANSI/AAMI BF7:2012 vii Foreword This standard was developed by the Blood Filter Committee of the Association for the Advancement of Medical Instrumentation. The objective of this standard is to describe those requirements which will ensure adequate delivery of filtered

48、stored blood and blood components while removing microaggregates without traumatizing blood components. This standard contains referee test methods to be used to ensure that the performance requirements are met. Establishing compliance with this standard may involve the use of hazardous materials, o

49、perations, and/or equipment. Therefore, users of this document should establish appropriate safety practices and proceed with caution. This standard reflects the conscientious efforts of concerned health care professionals, in consultation with medical device manufacturers, to develop a standard for those performance levels that could be reasonably achieved at this time. AAMI and ANSI procedures require that standards be reviewed every five years and, if necessary, revised to reflect technological advances that may have occurred since publication. As used within the cont