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1、 American National Standard ANSI/AAMI AT6:2005 Autologous transfusion devices Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/09/2007 03:01:30 MDTNo reproduction or ne
2、tworking permitted without license from IHS -,-,- The Objectives 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 technical development
3、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 view that standa
4、rds 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 recommends to the manufa
5、cturer the information that should be provided with or on the product, basic safety and performance criteria that should be con- sidered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance
6、 criteria and/or to compare the per- formance characteristics of different products. Some standards em- phasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensur
7、ing 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 considerable pa
8、rt 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 provides gu
9、idelines 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 maintained. Although
10、 a device standard is primarily directed to the manufac- turer, it may also be of value to the potential purchaser or user of the device as a fume of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards health care professionals, it may be useful
11、 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 collecting data
12、 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 needs of
13、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 recom- mended practice is solely wit
14、hin 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 internationally).
15、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 and condi
16、tions 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 or rec
17、ommended 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 remains relev
18、ant 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 basis for
19、the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equip- ment. 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 ultimat
20、e 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, the
21、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 and in
22、 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 Manager for Technical Development. An official interpretation must be approved by
23、 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 interpre- tation in the “Standards Monit
24、or“ 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 which is not publish
25、ed, by appropriate notice, as an official interpretation in the AAMI News. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/09/2007 03:01:30 MDTNo reproduction or netwo
26、rking permitted without license from IHS -,-,- AAMI/American National Standard ANSI/AAMI AT6:2005 (Revision of ANSI/AAMI AT6:1991/(R)1996) Autologous transfusion devices Developed by Association for the Advancement of Medical Instrumentation Approved 6 December 2005 by American National Standards In
27、stitute Abstract: This standard establishes labeling and performance requirements, test methods, and terminology that will help define a reasonable level of safety and efficacy for autologous transfusion devices. Specifically, it includes requirements for sterile, disposable systems and associated e
28、lectromechanical hardware designed to collect and filter or process, or both, extravasated blood for reinfusion of erythrocytes or filtered whole blood into the patients circulation. Aspects of these systems related to collection, anticoagulation (systemic and regional), storage, processing and filt
29、ration, and reinfusion are within the scope of this standard. Keywords: autologous, transfusion, blood, hemoglobin, reinfusion, infusion Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie N
30、ot for Resale, 04/09/2007 03:01:30 MDTNo reproduction or networking permitted without license from IHS -,-,- 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
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32、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 standard no later than 5 years from the date of publication. Interested parties may obtain current information
33、 on all AAMI standards by calling or writing AAMI. 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 docu
34、ment. 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 Association for the Advancement of Medical Instrumentation 1110 N. G
35、lebe Road, Suite 220 Arlington, VA 22201-4795 2006 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permi
36、ssion of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. 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 permission of the Associatio
37、n 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, contact AAMI at 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. P
38、hone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570202494 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/09/2007 03:01:30 MDT
39、No reproduction or networking permitted without license from IHS -,-,- Contents Glossary of equivalent standards.iv Committee representationvi Foreword.vii 1 Scope. 1 1.1 General 1 1.2 Inclusions. 1 1.2.1 Emergency/trauma devices 1 1.2.2 Intraoperative retrieval devices. 1 1.2.3 Postoperative device
40、s. 1 2 Normative references 1 3 Definitions 2 4 Requirements 3 4.1 Labeling requirements . 3 4.1.1 Electromechanical device markings . 3 4.1.2 Disposable blood contact components. 4 4.1.3 Operators manual/instructions for use.4 4.1.4 Service manual. 5 4.1.5 Collection container labeling. 5 4.2 Perfo
41、rmance requirements 5 4.2.1 System integrity 5 4.2.2 Cleanliness . 5 4.2.3 Regional anticoagulation 5 4.2.4 Filtration 6 4.2.5 Interface characteristics 6 4.2.6 Material safety requirements 6 4.2.7 Electrical safety. 6 4.2.8 Electromagnetic compatibility. 6 5 Tests 6 5.1 Compliance with labeling req
42、uirements. 7 5.2 Compliance with performance requirements. 9 5.2.1 System integrity 9 5.2.2 Cleanliness . 9 5.2.3 Regional anticoagulation 9 5.2.4 Filtration10 5.2.5 Interface characteristics10 5.2.6 Material safety requirements 10 5.2.7 Electrical safety.11 Annexes A Rationale for the development a
43、nd provisions of this standard .12 B Protocol for procuring and handling fresh anticoagulated human blood for laboratory testing.19 Bibliography .20 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wi
44、ng, Bernie Not for Resale, 04/09/2007 03:01:30 MDTNo reproduction or networking permitted without license from IHS -,-,- iv 2006 Association for the Advancement of Medical Instrumentation AAMI AT6:2004 Glossary of equivalent standards International Standards adopted in the United States may include
45、normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTEDocuments are sorted by international designation. Oth
46、er normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:
47、2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II51:200
48、4 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC TR 62296:2003 ANSI/AAMI/IE
49、C TIR62296:2003 Identical IEC TR 62348:200x1 ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:1992 ANSI/AAMI/ISO 10993-2:1993/(R)2001 Identic