ANSI AT6-2013 Autologous transfusion devices《自体输血装置》.pdf

1、ANSI/AAMI AT6:2013Autologous transfusion devicesAmerican 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 te

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24、nd which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI AT6:2013 (Revision of ANSI/AAMI AT6:2006/(R)2011) Autologous transfusion devices Developed by Association for the Advancement of Medical Instrumentation Approved 27

25、August 2013 by American National Standards Institute 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

26、 sterile, disposable systems and associated electromechanical 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 (systemi

27、c and device), storage, processing and filtration, and reinfusion are within the scope of this standard. Keywords: autologous, transfusion, blood, hemoglobin, reinfusion, infusion AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of tho

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36、ited States of America ISBN 1570205035 Contents Glossary of equivalent standards iv Committee representation . v Foreword . vi 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 devices 1 2 Normative references .

37、 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 Performance requirements . 5 4.2.1

38、System integrity . 5 4.2.2 Cleanliness 5 4.2.3 Device 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 requirements 7 5.2 Compli

39、ance with performance requirements 8 5.2.1 System integrity . 8 5.2.2 Cleanliness 9 5.2.3 Device anticoagulation . 9 5.2.4 Filtration . 9 5.2.5 Interface characteristics . 10 5.2.6 Material safety requirements . 10 5.2.7 Electrical safety 10 Annexes A Rationale for the development and provisions of

40、this standard 11 Bibliography 18 iv 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI AT6:2013 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current lis

41、t 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/standards/glossary.pdf 2013 Association for the Advan

42、cement of Medical Instrumentation ANSI/AAMI AT6:2013 v Committee representation Association for the Advancement of Medical Instrumentation AAMI Blood Filter/Cell Salvaging Committee This standard was developed by the Blood Filter/Cell Salvaging Committee. Committee approval of this standard does not

43、 necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Blood Filter/Cell Salvaging Committee had the following members: Cochair: Ralph Slepian, MD Members: Corey Bercaw, Zimmer, Inc. Dawn Desiderio, MD, Memorial Sloan Kettering Cancer

44、Center Trevor 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 George Silvay, MD, PhD, M

45、ount 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 Lindsey Lorenz, Zimmer Orthopaedic Surgical Products Jaroslav G. Vostal, MD, PhD, U.S. Food and

46、 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. vi 2013 Association for the Advancement of Medical Instrumentati

47、on ANSI/AAMI AT6:2013 Foreword This AAMI standard was developed by the Blood Filter/Cell Salvaging Committee as the result of a periodic review of ANSI/AAMI AT6:2006/(R)2011. Now in its fourth edition, this document was originally approved as an American National Standard in May, 1982 under the titl

48、e Autotransfusion devices. The objective of this standard is to provide labeling and performance requirements, test methods, and terminology that will help establish a reasonable level of safety and efficacy for autologous transfusion devices. The most significant differences between the third and f

49、ourth editions of this standard are updates intended to reflect current technology and updates to references. 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 possibility or course of action should be avoided but is not prohibited. “May”