BS PD ISO TS 17137-2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants《心血管植入物和体外系统 心血管可吸收性植入物》.pdf
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1、BSI Standards Publication Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants PD ISO/TS 17137:2014National foreword This Published Document is the UK implementation of ISO/TS 17137:2014. The UK participation in its preparation was entrusted by Technical Committee CH
2、/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its cor
3、rect application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 76893 4 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy a
4、nd Strategy Committee on 30 June 2014. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TS 17137:2014 ISO 2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants Implants cardiovasculaires et systmes extracorporels Implant
5、s cardiovasculaires absorbables TECHNICAL SPECIFICATION ISO/TS 17137 First edition 2014-05-15 Reference number ISO/TS 17137:2014(E) PD ISO/TS 17137:2014 ISO/TS 17137:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part
6、of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body
7、 in the country of the requester. ISO copyright 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 PD ISO/TS 17137:2014 ISO/TS 17137:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv
8、Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 2 4 Implant considerations . 2 4.1 Classification . 2 4.2 Intended clinical performance 3 4.3 Intended clinical use 3 4.4 Materials . 3 4.5 Packaging, labelling, and sterilization . 3 4.6 Risk management . 6 5 Design v er
9、ification and v alidation T esting and anal y sis . 7 5.1 Overview 7 5.2 Considerations in the characterization and assessment of material and implant properties . 9 5.3 in vitro procedural assessment 12 5.4 in vitro degradation assessment (post procedure) .13 5.5 in vitro-in vivo correlation (IVIVC
10、) .15 5.6 Biocompatibility .16 5.7 Pre-clinical in vivo evaluation 17 5.8 Clinical considerations specific to absorbable implants 19 5.9 Shelf life considerations .21 Annex A (informative) Nomenclature of absorb, degrade and related terms 23 Bibliography .24 PD ISO/TS 17137:2014 ISO/TS 17137:2014(E)
11、 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member 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
12、technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matter
13、s of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This docu
14、ment was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives 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 pa
15、tent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents Any trade name used in this document is information given for the convenience of users and does not cons
16、titute an endorsement. The committee responsible for this document is ISO/TC 150, Implants for surgery, sous-comit SC 2, Cardiovascular implants and extracorporeal systems. The following definitions apply in understanding how to implement an ISO International Standard and other normative ISO deliver
17、ables (TS, PAS, IWA): “shall” indicates a requirement; “should” indicates a recommendation; “may” is used to indicate that something is permitted; “can” is used to indicate that something is possible, for example, that an organization or individual is able to do something. 3.3.1 of the ISO/IEC Direc
18、tives, Part 2 (sixth edition, 2011) defines a requirement as an “expression in the content of a document conveying criteria to be fulfilled if compliance with the document is to be claimed and from which no deviation is permitted.” 3.3.2 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) define
19、s a recommendation as an “expression in the content of a document conveying that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative for
20、m) a certain possibility or course of action is deprecated but not prohibited.”iv ISO 2014 All rights reserved PD ISO/TS 17137:2014 ISO/TS 17137:2014(E) Introduction Absorbable cardiovascular implants are medical devices with various clinical indications for use in the human cardiovascular blood sys
21、tem. An absorbable cardiovascular implant, or at least a portion thereof, is designed to intentionally degrade over time into products that are absorbed by the body through metabolism, assimilation, and/or excretion (elimination). Such implants can be either surgically or interventionally introduced
22、 to the site of treatment. This Technical Specification outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. This Technical Specification should be considered as a suppl
23、ement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This Technical Specification should also be considered as a supplement to relevant device-specific standards such as the ISO 25539 series specifying requirements for endovascular devices, wh
24、ich do not address degradation and other time dependent aspects of absorbable implants and coatings. This Technical Specification is not comprehensive with respect to the pharmacological evaluation of cardiovascular absorbable implants. More detailed safety and performance requirements for pha r mac
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