ANSI AAMI 27186-2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements.pdf

1、Association for the Advancementof Medical InstrumentationANSI/AAMI/ISO 27186:2010Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements Objectives and uses of AAMI standards and recommended practices It is

2、 most important that 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

3、) a continued increase 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 the

4、y are drafted with attention 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

5、 considered in qualifying 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 t

6、hat should be provided 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 characterist

7、ics often necessitates 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

8、 performance criteria, 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 perfo

9、rmance per se, but rather 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 d

10、evice as a frame of 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 practic

11、es, while not addressing 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

12、to health care professionals 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 v

13、oluntary (unless, of 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 col

14、lective expertise of 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,

15、ultimately, to help 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 respons

16、ible decision-making, 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

17、 the reasons why the 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 equipme

18、nt, and in applying 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

19、equipment. No single 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 consi

20、derations. Similarly, 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 provi

21、sion. In summary, a 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 interpre

22、tations of AAMI standards 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 in

23、terpretation will become 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 fo

24、r any characterization 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 2718

25、6:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements Approved 10 August 2011 by Association for the Advancement of Medical Instrumentation Approved 24 August 2011 by American National Standards In

26、stitute, Inc. Abstract: This includes all essential design and performance requirements for two types of four-pole electrical connectors, low voltage and high/low voltage, intended for use on implantable cardiac pacemakers and implantable defibrillators. Keywords: pacemakers, implantable defibrillat

27、ors, active implants 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 respect preclude anyone, whether they have approved

28、 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 NOTICE: This AAMI standard may be revised or with

29、drawn 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 writing AAMI, or by visiting the AAMI website at

30、 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 of the document. Occasionally, voluntary techni

31、cal 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 Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, V

32、A 22203-1633 www.aami.org 2011 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 any form, including an electronic retrieval sys

33、tem, 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 externally) without the prior written permission

34、 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 the reprint request form at www.aami.org or con

35、tact AAMI, 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 157020380-6 Contents Page Glossary of equivalent standards iv Committee representation .vi Background of ANSI/AAMI adoption of ISO 27186:2

36、010 .vii Forewordviii Introduction .ix 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Requirements 5 Annex A (normative) Electrical isolation test23 Annex B (informative) Rationale for Annex A28 Annex C (normative) Dielectric strength test 30 Annex D (informative) Rationale for Annex

37、 C36 Annex E (normative) Current-carrying test high voltage types.40 Annex F (informative) Rationale for Annex E 45 Annex G (informative) Lead connector fatigue strength test.47 Annex H (informative) Lead connector seal zone materials 49 Annex I (informative) Seal zone creep51 Annex J (informative)

38、Contact resistance stability .57 Annex K (informative) Rationale for Annex J 61 Annex L (informative) Selection of contact materials.64 Annex M (normative) Lead connector contact material requirements .66 Annex N (informative) Rationale for Annex M .70 Annex O (informative) Rationale for requirement

39、s in this International Standard 77 Annex P (informative) Connector products (e.g. adaptors, extenders, patient cables, etc.)85 Bibliography .87 iv 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 27186:2010 Glossary of equivalent standards International Standards adopte

40、d 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 corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sor

41、ted 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 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normative

42、ly 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 Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1

43、:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 however, recommendations are provided in Annex H. 4.2.3 Lead connector electrical connections 4.2.3.1 According to the appropriate configuration, each lead connector contact shall be in ele

44、ctrical continuity with the specific and distinct lead electrode described in Table 1 when the following applies: “LOW voltage” refers to stimulating electrode s having pacing and electrogram sensing function; “HIGH voltage” refers to stimulating electrodes having high voltage defibrillation capabil

45、ity; “OPEN” refers to lead connector contacts that are not in electrical continuity with any lead electrode. 4.2.3.2 The lead connector pin of low voltage only lead connectors shall conform to Figure 2 b). 4.2.3.3 The lead co nnector pin of high voltage l ead connectors including integrated bipolar

46、connectors shall conform to Figure 2 a). NOTE Ring 2 and ring 3 contacts of high voltage lead connectors should not be in direct electrical continuity with lead electrodes that are not intended for high voltage. 4.2.4 Lead marking 4.2.4.1 Marking symbol Lead connectors shall be marked with the a ppr

47、opriate symbol according to Tabl e 1 and sized appropriately for the component being marked. 4.2.4.2 Marking location Marking shall be located in the marking zone (see Figure 3). 4.2.4.3 Marking orientation Marking shall read left to right when the lead connector is oriented with the connector pin t

48、o the left. 10 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 27186:2010 NOTE It is the responsibility of the manufacturer to ensure marking on lead connectors is permanent and legible under intended use conditions. Dimensions in millimeters Key 1 marking zone 2 lead c

49、onnector pin 3 lead connector ring 1 4 lead connector ring 2 5 lead connector ring 3 Figure 3 Identification of lead connector contacts Table 1 Lead marking symbols and electrical connections within the lead Permitted configurations Configuration and marking symbol Connector pin Ring 1 Ring 2 Ring 3 IS4-LLLL Most distal LOW voltage electrode 2nd most distal LOW voltage electrode 3rd most distal LOW voltage electrode Most proximal LOW voltage electrode IS4-LLLO Most distal LOW voltage electrode 2nd most distal LOW voltage electrode 3rd most distal LOW voltage electr