1、ANSI/AAMI/ISO 14708-3: 2017Implants for surgery Active implantable medical devices Part 3: Implantable neurostimulatorsAmerican 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
2、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 application of current technologies t
3、o 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 provided that arbitrary and restr
4、ictive 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 the measurement techniques
5、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 performance characteristics, instruc
6、tions 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 methods to facilitate unifo
7、rmity 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 the reasons for establishing
8、 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 will help ensure that a device
9、 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. Similarly, even though a recommen
10、ded 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, provide guidelines to industrial
11、 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 practices. In determining whe
12、ther 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 regulatory or procurement
13、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 professionals and industrial represent
14、atives, 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 recommended practice is limit
15、ed, 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 responsible decision-making. Despite
16、 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 the specific rationale for e
17、ach 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 procedures and practices. While
18、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 identify a particular product
19、 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 analyzed in the context of the
20、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 truly useful only when it is u
21、sed 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 made in writing, to the AA
22、MI 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 Association only upon exha
23、ustion 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 recommended practice which has
24、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 14708-3:2017 Implants for surgery Active implantable medical devices Part 3: Implantable n
25、eurostimulators Approved 28 February 2017 by AAMI Approved 2 March 2017 by American National Standards Institute Abstract: Specifies particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system in order to provide basi
26、c assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. Keywords: implant, nerves, neurosurgery AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and
27、 provisions. The existence of an AAMI 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
28、, and users are cautioned 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
29、obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website 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
30、 solely within the discretion and professional 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. Pu
31、blished by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 Uwww.aami.orgUH 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this publication may be reproduced or distr
32、ibuted 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 document (whether inter
33、nally 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 of this document,
34、 complete the reprint request form at HUwww.aami.orgUH or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-658-0 Contents Page Glossary of equivalent standards . v Backgr
35、ound of AAMI adoption of ISO 14708-3:2017 . vii Foreword viii Introduction . ix 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Symbols and abbreviated terms . 2 5 General requirements for active implantable medical devices 2 6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DE
36、VICES 3 7 General arrangement of the packaging . 3 8 General markings for ACTIVE IMPLANTABLE MEDICAL DEVICES 3 9 Markings on the sales packaging . 3 10 Construction of the sales packaging . 3 11 Markings on the sterile pack . 3 12 Construction of the non-reusable pack . 3 13 Markings on the ACTIVE I
37、MPLANTABLE MEDICAL DEVICE . 3 14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE 3 15 Protection from harm to the patient or user caused by external physical features of the ACTIVE IMPLANTABLE MEDICAL DEVICE 4 16 Protection from harm to the pati
38、ent caused by electricity . 4 17 Protection from harm to the patient caused by heat 4 18 Protection from ionizing radiation released or emitted from the active implantable medical device 5 19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE 5 20 Protection of the AC
39、TIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external defibrillators . 5 21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical fields applied directly to the patient . 5 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscella
40、neous medical treatments 5 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces . 6 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic discharge 7 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric
41、 pressure changes 7 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature changes 7 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation 7 28 Accompanying documentation 16 Annex AA (normative) Relationship between the f
42、undamental principles in ISO/TR 14283 1and the clauses of this document 18 Annex BB (informative) Rationale 28 Annex CC (informative) Injection network example and board layout guidance . 38 Bibliography . 51 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 14708-3:2017
43、v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the addre
44、ss below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf vi 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 14708-3:2017 Committee representation Association for the Advancem
45、ent of Medical Instrumentation Implantable Neurostimulators Working Group The adoption of ISO 14708-3 as an American National Standard was initiated by the AAMI Implantable Neurostimulators Working Group (NS/WG 2). AAMI NS/WG 2 functions as a U.S. sub-Technical Advisory Group to the relevant work in
46、 the International Organization for Standardization (ISO). U.S. representatives from AAMI NS/WG 2 played a very active part in developing the ISO standard. At the time this document was published, the AAMI Implantable Neurostimulators Working Group had the following members: Cochairs: Daniel Aghassi
47、an, Boston Scientific Members: Kristen Bowsher, FDA/CDRH Bryan Byerman, LivaNova PLC Warren Dabney, Micro Systems Engineering Inc Rob Egemo, St Jude Medical Inc Harry Friedman, Memphis Neurosurg Clinic PC Barbara Gibb, NeuroPace Inc Jeff Johnson, University of Cinncinnati Richard North, Sinai Hospit
48、al of Baltimore Eric Schepis, Halyard Health Curt Sponberg, Medtronic Inc Campus Bob Stevenson, Greatbatch Medical Alternates: Amar Chanani, Halyard Health Hongying Cui, Medtronic Inc Campus John Doucet, FDA/CDRH Casey Haley, LivaNova PLC Ron Reitan, Boston Scientific Corporation NOTEParticipation b
49、y federal agency representatives in the development of this standard does not constitute endorsement by the federal government or any of its agencies. 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 14708-3:2017 vii Background of AAMI adoption of ISO 14708-3:2017 As indicated in the foreword to the main body of this document (page viii), the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The United States is one of the ISO members that took an active role in the development
