ANSI AAMI 14708-1-2014 Implants for surgery - Active implantable medical devices - Part 1 General requirements for safety marking and for information to be provided by the manufact.pdf

1、ANSI/AAMI/ISO 14708-1:2014Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturerAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that

2、 the 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 increa

3、se 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 a

4、ttention 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 quali

5、fying 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 provid

6、ed 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 necessitat

7、es 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 criteri

8、a, 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 r

9、ather 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

10、reference 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 addres

11、sing 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 profe

12、ssionals 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

13、 course, 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

14、 a 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

15、ensure 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

16、 but 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

17、 document 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

18、a recommended 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

19、 source 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

20、 a 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

21、standard 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 stan

22、dards 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 be

23、come 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 characterizati

24、on 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. AAMI American National Standard ANSI/AAMI/ISO 14708-1:2014 Implan

25、ts for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer Approved 29 September 2014 by Association for the Advancement of Medical Instrumentation Approved 8 October 2014 by American National Standards In

26、stitute Abstract: Specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in this document are type tests and are to be carried out on samples of an active implantable medical device to show compliance. This document is applicable not

27、only to active implantable medical devices that are electrically powered but also to those powered by other energy sources. This document is also applicable to some non-implantable parts and accessories of the active implantable medical devices. Keywords: AIMD, pacemakers, ICDs, cochlear implants, i

28、mplantable neurostimulators, implantable infusion pumps, tachyarrhythmia 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

29、 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 the latest editions. CAUTI

30、ON 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 on all AAMI standards by calling or

31、 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 professional judgment of the use

32、r 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 Instrumentat

33、ion 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 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 i

34、n 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

35、 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, complet

36、e the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-565-5 Contents Page Glossary of equivalent standards . v Committee representati

37、on vi Background of ANSI/AAMI adoption of ISO 14708-1:2014 . vii Foreword viii Introduction . ix 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Symbols and abbreviations (optional) . 7 5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES 7 6 Requirements for particular ACTIV

38、E IMPLANTABLE MEDICAL DEVICES 9 7 General arrangement of the packaging . 9 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES . 9 9 MARKINGS on the SALES PACKAGING . 10 10 Construction of the SALES PACKAGING 11 11 MARKINGS on the STERILE PACK 12 12 Construction of the NON-REUSABLE PACK . 13 1

39、3 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 13 14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE 14 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE IMPLANTABLE MEDICAL DEVICE 16 16 Pro

40、tection from HARM to the patient caused by electricity . 16 17 Protection from HARM to the patient caused by heat. 16 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL DEVICE 17 19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL

41、 DEVICE 17 20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external defibrillators . 18 21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical fields applied directly to the patient . 22 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DE

42、VICE from changes caused by miscellaneous medical treatments 22 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces . 23 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic discharge 25 25 Protection of the ACTIVE IMPLANTABLE MEDICAL D

43、EVICE from damage caused by atmospheric pressure changes 25 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature changes 25 27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing radiation 26 28 Accompanying documentation 27 Annex

44、 A (informative) General guidance and rationale . 31 Annex B (informative) Relationship between the fundamental principles in ISO/TR 14283:2004 and the clauses of this part of ISO 14708 41 Bibliography . 52 iv 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 14708-1:2014

45、 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 addres

46、s below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 14708-1:2014 v Committee representation Association for the Advancemen

47、t of Medical Instrumentation U.S. TAG to ISO/TC 150/SC 6, Active implants The adoption of ISO 14708-1 as an American National Standard was initiated by the U.S. TAG to ISO/TC 150/SC 6, Active implants. The U.S. TAG to ISO/TC 150/SC 6 functions as a U.S. Technical Advisory Group to the relevant work

48、in the International Organization for Standardization (ISO). U.S. representatives from the U.S. TAG for ISO/TC 150/SC 6 played an active part in developing the ISO standard. At the time this document was published, the U.S. TAG to ISO/TC 150/SC 6, had the following members: Chairs: Roger G. Carrillo

49、 MD, University of Miami Hospital Ron Reitan, Boston Scientific Corporation Members: Tushar Dharampal, St Jude Medical Inc Veronica Ivans, IMD Standards LLC Victor Kokx, Cyberonics Inc Whitney Ligon, Integrated Medical Systems Cedric Navarro, Advanced Bionics LLC Mike Schmidt, Strategic Device Compliance Services Mitchell Shein, FDA/CDRH Chuck Sidebottom, PPO Standards LLC Curt Sponberg, Medtronic Inc WHQ Campus Bob Stevenson, Greatbatch Inc Alternates: Charles Farlow, Medtronic WHQ Campus Christine Frysz, Greatbatch Inc. James Kippola, Boston Scientific Corporation Vic