1、Association for the Advancementof Medical InstrumentationANSI/AAMI/ISO 14708-5:2010Implants for surgeryActive implantable medical devicesPart 5: Circulatory support devicesObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of a
2、n 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 in the safe and effective applicatio
3、n 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 attention to these objectives and provid
4、ed 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 qualifying the device for clinical use, and
5、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 with the device, including performan
6、ce 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 the development of specialized test
7、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, referee tests must be provided and t
8、he 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 rather procedures and practices that wil
9、l 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 reference for device evaluation. Simila
10、rly, 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 addressing device performance criteria, provi
11、de 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 professionals in understanding industrial pr
12、actices. 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 course, they are adopted by government
13、 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 committee of health care professiona
14、ls 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 ensure patient safety. A standard or re
15、commended 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, but it should never replace responsib
16、le 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 document was initially developed and t
17、he 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 recommended practice to current proce
18、dures 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 source of information will serve to id
19、entify 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 recommended practice should be anal
20、yzed 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 standard or recommended practice is tru
21、ly 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 standards and recommended practices must be
22、 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 become official and representation of the
23、 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 or explanation of a standard or reco
24、mmended 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 14708-5:2010 (Revision of AAMI TIR26:2000) Implants for surgery
25、Active implantable medical devices Part 5: Circulatory support devices Approved 8 March 2010 by Association for the Advancement of Medical Instrumentation Approved 1 April 2010 by American National Standards Institute, Inc. Abstract: Specifies requirements for safety and performance of active implan
26、table circulatory support devices. Excluded from this scope are intra-aortic balloon pumps, external corporeal perfusion devices and cardiomyplasty. This standard specifies type tests, animal studies and clinical evaluation requirements that are to be carried out to show compliance with this standar
27、d. Keywords: artificial heart, ventricular assist devices, active implants, LVADs, TAHs, 14708-5 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
28、standard does not in any respect 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 th
29、e 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 five years from the date of publication. Interested parties may obtain current information on all A
30、AMI standards by calling or writing 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 profe
31、ssional judgment of the user 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 Advancem
32、ent of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 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 rep
33、roduced 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 this documen
34、t (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 any part o
35、f this document, complete the reprint request form at www.aami.org or contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 157020378-4 Contents Page Glossary of equivalent standards .v Committe
36、e representation vii Background of ANSI/AAMI adoption of ISO 14708-5:2010 viii Forewordix Introduction x 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Symbols and abbreviated terms6 5 General requirements for non-implantable parts 6 6 Requirements for particular active implantable m
37、edical devices6 7 General arrangement of the packaging 21 8 General markings for active implantable medical devices.21 9 Markings on the sales packaging21 10 Construction of the sales packaging22 11 Markings on the sterile packaging22 12 Construction of the non-reusable packaging22 13 Markings on th
38、e active implantable medical device .23 14 Protection from unintentional biological effects caused by the active implantable medical device.23 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device23 16 Protection from harm to the
39、 patient caused by electricity .23 17 Protection from harm to the patient caused by heat.23 18 Protection from ionizing radiation released or emitted from the active implantable medical device.23 19 Protection from unintended effects caused by the device.23 20 Protection of the device from damage ca
40、used by external defibrillators.25 21 Protection of the device from changes caused by high-power electrical fields applied directly to the patient25 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments .25 23 Protection of the active implanta
41、ble medical device from mechanical forces.25 24 Protection of the active implantable medical device from damage caused by electrostatic discharge.25 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes.25 26 Protection of the active implantable me
42、dical device from damage caused by temperature changes25 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation 26 28 Accompanying documentation .26 Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of t
43、his part of ISO 14708.28 Annex BB (informative) Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in Annex AA38 Annex CC (informative) Rationale.40 Annex DD (informative) In vitro test .45 Bibliography .49 2010 Association for the Advancement of Medical
44、 Instrumentation ANSI/AAMI/ISO 14708-5:2010 v 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 c
45、orresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exha
46、ustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 additional annexes are lettered AA, BB, etc. x 2010 Association for
47、the Advancement of Medical Instrumentation ANSI/AAMI/ISO 14708-5:2010 American National Standard ANSI/AAMI/ISO 14708-5:2010 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices 1 Scope This part of ISO 14708 specifies requirements for safety and performance of
48、active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps. This part of ISO 14708 specifies type tests, animal studies and clinical eva
49、luation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. 2 Normative references The following referenced documents are indispensable for the applicatio
