1、Association for the Advancementof Medical InstrumentationANSI/AAMI/ISO 8638:2010Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for hemodialyzers,hemodiafilters and hemofiltersObjectives and uses of AAMI standards and recommended practices It is most important that th
2、e objectives and potential uses of an AAMI product standard or recommended practice 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
3、in the safe and effective application of current technologies to patient care, and (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 atte
4、ntion to these objectives and provided that arbitrary and restrictive uses are avoided. 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 qualifyi
5、ng the device for clinical use, and the measurement techniques that can be used to determine 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
6、with the device, including performance characteristics, instructions for use, warnings 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
7、the development of specialized test methods to facilitate uniformity in reporting; reaching 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,
8、referee tests must be provided and the reasons for establishing the criteria must be 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 rath
9、er procedures and practices that will help ensure that a device is used safely and effectively 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 ref
10、erence for device evaluation. Similarly, even though a recommended practice is usually 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 addressin
11、g device performance criteria, provide guidelines to industrial personnel on such subjects 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 professi
12、onals in understanding industrial practices. In determining whether an AAMI standard 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 co
13、urse, they are adopted by government regulatory or procurement authorities). The application 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
14、committee of health care professionals and industrial representatives, whose work has 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 ens
15、ure patient safety. A standard or recommended practice is limited, however, in the sense 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, b
16、ut it should never replace responsible decision-making. Despite periodic review and 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 do
17、cument was initially developed and the specific rationale for each of its provisions. 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 r
18、ecommended practice to current procedures and practices. While observed or potential 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 so
19、urce of information will serve to identify a particular product as “unsafe“. A voluntary 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
20、 recommended practice should be analyzed in the context of the specific needs and resources 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 sta
21、ndard or recommended practice is truly useful only when it is used in conjunction with 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 standar
22、ds and recommended practices must be made in writing, to the AAMI Vice President, Standards 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 becom
23、e official and representation of the Association only upon exhaustion of any appeals 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
24、or explanation of a standard or recommended practice which has not been developed and 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 8638:2010 (Revision of ANSI
25、/AAMI RD17:2007) Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters Approved 26 July 2010 by Association for the Advancement of Medical Instrumentation Approved 3 August 2010 by American National Standards Institute, Inc.
26、 Abstract: Specifies requirements for the single-use extracorporeal blood circuit and (integral and non-integral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration and hemofiltration. Keywords: biological safety, connectors, labeling, mechanical integrity, nonpyroge
27、nicity, sample port, pump segment, sterility, transducer protectors 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 resp
28、ect 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 editions. CAUTION NO
29、TICE: 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 five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or w
30、riting AAMI, or by visiting the AAMI website at www.aami.org. 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
31、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 Association for the Advancement of Medical Instrumentatio
32、n 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2010 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
33、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 this document (whether internally or e
34、xternally) 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 any part of this document, complete
35、the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 157020391-1 Contents Page Glossary of equivalent standards iv Committee representation .vi Ba
36、ckground of ANSI/AAMI adoption of ISO 8638:2010 vii Forewordviii Introduction .ix 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Requirements 3 4.1 Biological safety3 4.2 Sterility .3 4.3 Nonpyrogenicity3 4.4 Mechanical characteristics 3 4.5 Expiry date.5 4.6 Tubing compliance .6 5 T
37、est methods.6 5.1 General.6 5.2 Biological safety6 5.3 Sterility .6 5.4 Nonpyrogenicity6 5.5 Mechanical characteristics 7 5.6 Expiry date.11 5.7 Tubing compliance .11 6 Labeling .11 6.1 Labeling on the device .11 6.2 Labeling on the unit container.11 6.3 Labeling on the outer container 12 6.4 Accomp
38、anying documentation .12 Bibliography .14 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corre
39、sponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 1
40、0993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other 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 Eq
41、uivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 plasmafilters; hemoperfusion devices; vascular access devices; blood pumps; pressure
42、 monitors for the extracorporeal blood circuit; air detection devices; systems to prepare, maintain or monitor dialysis fluid; systems or equipment intended to perform hem odialysis, hemodiafiltration, hemofiltration or hemoconcentration. NOTE Requirements for hemodialyzers, hemodiafilters, hemofilt
43、ers and hemoconcentrators are specified in ISO 8637. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (includin
44、g any amendments) applies. ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 7864, Sterile hypodermic needles for single use 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 8638:2010 1 I
45、SO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxi
46、de sterilization residuals ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 air capture chamber component intended to capture air and which can provide
47、 compliance to the blood circuit or allow pressure to be monitored NOTE Air capture chambers are also known as drip chambers, bubble traps or venous and arterial blood chambers. 3.2 extracorporeal blood circuit blood tubing and integral accessory tubing, including fluid and infusion tubing, for atta
48、ching the extracorporeal blood circuit to pressure monitors and integral components EXAMPLES (Of integral components.) Air-capture chambers and transducer protectors. 3.3 fluid pathway internal surfaces of the extracorporeal blood circuit 3.4 labeling written, printed, graphic or electronic matter t
49、hat: is affixed to a medical device or any of its containers or wrappers or accompanies a medical device and which is related to identification, technical description and use of that medical device, but excluding shipping documents 3.5 pump segment portion of the extracorporeal blood circuit (3.2) that is acted upon by the blood pump 3.6 transducer protector pressure-transmitting sterile barrier component of the extracorporeal blood circuit (3.2) that is intended to provide an interconnection between the extracorporeal blood circuit and the hemodia
