BS ISO 27186-2013 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements《有源可植入医疗器械 可植入心节律.pdf
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1、BSI Standards PublicationBS ISO 27186:2010Active implantable medicaldevices Four-pole connectorsystem for implantable cardiacrhythm management devices Dimensional and testrequirementsBS ISO 27186:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 27186:2010.T
2、he UK participation in its preparation was entrusted to TechnicalCommittee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users
3、are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 65011 6ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theS
4、tandards Policy and Strategy Committee on 31 August 2013.Amendments issued since publicationDate Text affectedBS ISO 27186:2010Reference numberISO 27186:2010(E)ISO 2010INTERNATIONAL STANDARD ISO27186First edition2010-03-15Active implantable medical devices Four-pole connector system for implantable
5、cardiac rhythm management devices Dimensional and test requirements Dispositifs mdicaux actifs implantables Systmes de branchement quatre ples pour grer le rhythme cardiaque Dimensions et exigences dessai BS ISO 27186:2010ISO 27186:2010(E) PDF disclaimer This PDF file may contain embedded typefaces.
6、 In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing
7、Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized
8、for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2010 All rights reserved. Unless
9、otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copy
10、right office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedBS ISO 27186:2010ISO 27186:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Sc
11、ope1 2 Normative references1 3 Terms and definitions .2 4 Requirements.5 Annex A (normative) Electrical isolation test 22 Annex B (informative) Rationale for Annex A 27 Annex C (normative) Dielectric strength test.29 Annex D (informative) Rationale for Annex C 35 Annex E (normative) Current-carrying
12、 test high voltage types .39 Annex F (informative) Rationale for Annex E.44 Annex G (informative) Lead connector fatigue strength test.46 Annex H (informative) Lead connector seal zone materials.47 Annex I (informative) Seal zone creep 49 Annex J (informative) Contact resistance stability .54 Annex
13、K (informative) Rationale for Annex J.58 Annex L (informative) Selection of contact materials .60 Annex M (normative) Lead connector contact material requirements62 Annex N (informative) Rationale for Annex M66 Annex O (informative) Rationale for requirements in this International Standard.72 Annex
14、P (informative) Connector products (e.g. adaptors, extenders, patient cables, etc.) 79 Bibliography81 BS ISO 27186:2010ISO 27186:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member
15、 bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental
16、 and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directiv
17、es, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies
18、casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 27186 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subco
19、mmittee SC 6, Active implants. BS ISO 27186:2010ISO 27186:2010(E) ISO 2010 All rights reserved vIntroduction The purpose of this International Standard is to specify a four-pole connector assembly to provide interchangeability between implantable leads and pulse generators for cardiac rhythm managem
20、ent from different manufacturers. The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. The four-pole connector was created to allow for a reduction in the number of individual lead connectors, reduce pocket bulk assoc
21、iated with existing bifurcated or trifurcated leads, reduce interaction of the lead bodies in the pocket and reduce set screw connections. This International Standard establishes two types of connector assembly: a “high voltage connector” and a “low voltage only connector”, each of which has several
22、 configurations. The high voltage connectors either have two low voltage contacts combined with one or two high voltage contacts, or they have only two high voltage contacts. The low voltage only connectors have either three or four low voltage contacts. The high voltage and low voltage only connect
23、ors and their voltage configurations are not intended to be interchangeable. This International Standard specifies a dimensional lockout feature that prevents the low voltage contacts of the lead connectors from contacting the high voltage contacts of high voltage connector cavities. BS ISO 27186:20
24、10BS ISO 27186:2010INTERNATIONAL STANDARD ISO 27186:2010(E) ISO 2010 All rights reserved 1Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements WARNING The low voltage only connector cavity specified in this
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