1、ANSI/AAMIBF64:2012Leukocyte reduction filtersAmerican 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 techn
2、ical 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 AAMIs
3、 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 avoided. A voluntary standard for a medical device recomme
4、nds 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 determine whether the device conforms with the safety
5、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, warnings and precautions, and other data considered importa
6、nt 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; reaching consensus on these tests can represent a cons
7、iderable 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 documented in the rationale. A recommended practice
8、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 effectively and that its performance will be maintaine
9、d. 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 usually oriented towards healthcare professionals, it may
10、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 subjects as sterilization processing, methods of collec
11、ting 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 or recommended practice is relevant to the specific
12、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 application of a standard or recommended practice is sol
13、ely 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 has been reviewed nationally (and sometimes internation
14、ally). 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 sense that it responds generally to perceived risks an
15、d 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 revision (at least once every five years), a standard
16、 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. This review will reveal whether the document remain
17、s 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 risks with existing equipment typically form the bas
18、is 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 voluntary standard can be used as one resource, but the ul
19、timate 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 resources of the individual institution or firm. Again,
20、 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 with other sources of information and policy guidance a
21、nd 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, Standards Policy and Programs. An official interpretati
22、on 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 and upon publication of notice of interpretation in
23、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 and communicated in accordance with this procedure and
24、which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI BF64:2012 (Revision of ANSI/AAMI BF64:2002/(R)2011) Leukocyte reduction filters Developed by Association for the Advancement of Medical Instrumentation Approved 29 Nove
25、mber 2012 by American National Standards Institute, Inc. Abstract: This standard contains labeling requirements, performance requirements, test methods, and terminology for disposable filters used for the reduction of leukocytes from blood or blood components. Keywords: blood, filter, leukocyte, leu
26、koreduction, reduction, safety 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 not in any respect preclude anyone, whether they hav
27、e 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 editions. CAUTION NOTICE: This AAMI standard may be revis
28、ed 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 calling or writing AAMI, or by visiting the AAMI web
29、site 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 judgment of the user of the document. Occasionally, volun
30、tary 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 Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 A
31、rlington, 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 may be reproduced or distributed in any form, including an electroni
32、c 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 this document (whether internally or externally) without the prior wri
33、tten 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 any part of this document, complete the reprint request form at HUww
34、w.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 157020487X Contents Page Glossary of equivalent standards iv Committee representation v Foreword . vi 1 Scope 1 1.1 G
35、eneral 1 1.2 Inclusions . 1 1.3 Exclusions 1 2 Normative references . 1 3 Definitions . 2 4 Requirements . 2 4.1 Labeling requirements . 2 4.1.1 General 2 4.1.2 Primary package labeling 2 4.1.3 Instructions for use 3 4.1.4 Supporting information 3 4.2 Performance requirements 4 4.2.1 Packaging 4 4.2
36、.2 Filter device characteristics . 4 4.2.3 Device materials 4 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 with attached administration sets 6 4.3.2 Dockable filters 6 4.4 Mater
37、ial safety 6 4.4.1 Evaluation of potential toxicity . 6 4.4.2 Sterility . 6 4.4.3 Pyrogenicity . 6 5 Tests . 6 5.1 Labeling . 6 5.1.1 General 6 5.1.2 Primary package labeling 6 5.1.3 Instructions for use 6 5.1.4 Supporting information 6 5.2 Performance requirements 7 5.2.1 Packaging 7 5.2.2 Structur
38、al integrity 7 5.2.3 Filter performance . 7 5.3 Interface characteristics . 8 5.3.1 Filters with attached administration sets 8 5.4 Material safety 9 5.4.1 Evaluation of potential toxicity . 9 5.4.2 Sterility . 9 5.4.3 Pyrogenicity . 9 Annexes A Rationale for the development and provisions of this s
39、tandard 10 B Bibliography 13 iv 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI BF64:2012 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list o
40、f 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/standards/glossary.pdf 2013 Association for the Advancem
41、ent of Medical Instrumentation ANSI/AAMI BF64:2012 v 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 the standard does not necessarily imply that all commi
42、ttee 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 Desiderio, MD, Memorial Sloan Kettering Cancer Center
43、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 Sinai School of Medicine Donald Sherratt, Terumo BCT,
44、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. Vostal, MD, PhD, U.S. Food and Drug Administration/Ce
45、nter 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. vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI BF64:2012
46、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 for leukocyte reduction filters that will ensure the safe, effective, and reproducible reduction of t
47、he leukocyte content of blood components. This standard also contains referee test methods used to ensure that the performance requirements are met. Establishing compliance with this standard might involve the use of hazardous materials, operations, or equipment. Therefore, users of this document sh
48、ould 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 th
49、is 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 context of this document, “shall” indicates requirements strictly to be followed 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 pos
