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

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

25、olog ic a l agent s included in t he absorbable c a rdiova sc u la r impla nt a re desc r ibed in ISO/ T S 12417. Only issues related to absorption combined with the cardiovascular implant are covered by this Technical Specification. NOTE For issues related to the common mechanical function of the c

26、ardiovascular implant, the reader might find it useful to consider a number of other International Standards (see Bibliography). ISO 2014 All rights reserved v PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants 1 Scope This Technical Specificat

27、ion outlines design verification and validation considerations for absorbable cardiovascular implants. NOTE Due to the variations in the design of implants covered by this Technical Specification and in some cases due to the relatively recent development of some of these implants (e.g. absorbable st

28、ents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this Technical Specification will be necessary. For the purpose of this Technical Specification the terms “vessel and/or vasc

29、ular space” refer to the entire circulatory system, including the heart and all vasculature. This Technical Specification is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This technical specification does not addres

30、s the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non- viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angi

31、oplasty devices) are excluded from the scope of this Technical Specification if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant may incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the act

32、ion of the medicinal substance is ancillary to that of the implant and supports the primary mode of action of the implant. NOTE Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are add

33、ressed in ISO/TS 12417. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced docum

34、ent (including any amendments) applies. ISO 10993 (all parts), Biological evaluation of medical devices ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137 (all

35、 parts), Sterilization of health care products Radiation ISO/TS 12417, Cardiovascular implants and extracorporeal systemsVascular device-drug combination products ISO 14155:2011, Clinical Investigation of Medical Devices for Human Subjects Good Clinical Practice ISO 14630:2012, Non-active surgical i

36、mplants General requirements ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971:2007, Medical devices Application of risk manage

37、ment to medical devices ISO/TR 15499, Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process TECHNICAL SPECIFICATION ISO/TS 17137:2014(E) ISO 2014 All rights reserved 1 PD ISO/TS 17137:2014 ISO/TS 17137:2014(E) ISO 17665-1, Steriliz

38、ation of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 25539-2:2008, Cardiovascular implants Endovascular devices Part 2: Vascular stents ISO 5840 (all parts), Cardiovascular implants Cardia

39、c valve prostheses ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems IEC 62366, Medical devices Application of usability engineering to medical devices ASTM F2394-07(2013), Standard Guide for Measur

40、ing Securement of Balloon Expandable Vascular Stent Mounted on Delivery System 3 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 3.1 absorbaction of a non-endogenous (foreign) material or substance passing through or being assimilated by cells a

41、nd/or tissue over time 3.2 degradation product (noun) byproduct (noun) any intermediate or final result from the physical, metabolic, and/or chemical decomposition of a material or substance 3.3 degrade (verb) to physically, metabolically, and/or chemically decompose a material or substance 3.4 leac

42、hable (adjective) substances that can be released from a medical device or material during clinical use Note 1 to entry: In absorbable devices, leachables may be substances released from the as-manufactured product or substances generated and released as a consequence of its degradation (i.e. degrad

43、ation products). 4 Implant considerations 4.1 Classification A cardiovascular absorbable implant is a product that is considered to be a medical device that accomplishes its intended clinical use and performance over a defined time period. A cardiovascular absorbable implant accomplishes its intende

44、d clinical use and is then absorbed by the body over a finite period of time. The implants temporary nature is provided by its ability to degrade and the resulting products ability to be metabolized, assimilated, and/or excreted (eliminated) over time. An absorbable cardiovascular implant may also i

45、ncorporate a medicinal substance. However, for the purposes of this Technical Specification, if the action of the medicinal substance is ancillary to a devices primary mode of action, the product is considered to be a surgical implant. The manufacturer shall determine the acceptability of the produc

46、t for clinical use at all stages of the product life cycle.2 ISO 2014 All rights reserved PD ISO/TS 17137:2014 ISO/TS 17137:2014(E) 4.2 Intended clinical performance The intended performance of an absorbable implant shall be described and documented by addressing at least the following, with particu

47、lar regard to patients safety: a) intended purpose(s); b) intended lifetime. 4.3 Intended clinical use The intended clinical location shall be identified as one or more of the following: a) abdominal aorta; b) arterio-venous shunt for vascular access; c) carotid artery; d) coronary artery; e) corona

48、ry heart chambers; f) femoral artery; g) iliac artery; h) popliteal artery; i) intra-cerebral artery; j) renal artery; k) thoracic aorta; l) thoraco-abdominal aorta; m) tibial artery; n) other arterial or venous vessels to be specified. 4.4 Materials The requirements of ISO 14630:2012, Clause 6, sha

49、ll apply. Additional testing appropriate to specific material types (e.g. metals, polymers, drugs) shall be performed to determine material acceptability for use in the design. For example, a general guide for assessing absorbable polymeric implants can be found in ASTM F2902. In a more specific example, absorbable materials dependent on shape memory properties should be subjected to testing that assesses transformation properties. For drug-eluting absorbable implants, drug identity testing shall be perf