BS-ISO-25539-1-2003.pdf
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1、BRITISH STANDARD BS ISO 25539-1:2003 Cardiovascular implants Endovascular devices Part 1: Endovascular prostheses ICS 11.040.40 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 25539-1:2003 This British Standard was published under t
2、he authority of the Standards Policy and Strategy Committee on 27 March 2003 BSI 27 March 2003 ISBN 0 580 41502 3 National foreword This British Standard reproduces verbatim ISO 25539-1:2003 and implements it as the UK national standard. The UK participation in its preparation was entrusted by Techn
3、ical Committee CH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international
4、publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all th
5、e necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on th
6、e interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages
7、1 to 42, an inside back cover and a back cover The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:44 GMT+00:00 2006, Uncontrolled Copy, (
8、c) BSI Reference number ISO 25539-1:2003(E) INTERNATIONAL STANDARD ISO 25539-1 First edition 2003-03-01 Cardiovascular implants Endovascular devices Part 1: Endovascular prostheses Implants cardiovasculaires Dispositifs endovasculaires Partie 1: Prothses endovasculaires BS ISO 255391:2003 Licensed C
9、opy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 255391:2003 ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-93552 O1:(3002E) I SO 3002 All irhgts seredevr iii Contents Page Forewo
10、rdiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Intended performance 3 5 Design attributes.3 5.1 General.3 5.2 Delivery system.4 5.3 Implant4 6 Materials.4 7 Design evaluation .5 7.1 General.5 7.2 Delivery (and/or endovascular) system5 7.3 Implant11 7.4 Preclinical
11、 in vivo evaluation.19 7.5 Clinical evaluation.22 8 Manufacturing .25 9 Sterilization25 9.1 Products supplied sterile.25 9.2 Products supplied non-sterile .26 9.3 Sterilization residuals.26 10 Packaging 26 10.1 Protection from damage in storage and transport26 10.2 Marking.27 10.3 Information suppli
12、ed by the manufacturer.27 Annex A (informative) Attributes of endovascular devices Technical and clinical considerations.29 Annex B (informative) Bench and analytical tests36 Annex C (informative) Definitions of reportable clinical events39 Bibliography .42 BS ISO 255391:2003 iii Licensed Copy: shef
13、fieldun sheffieldun, na, Sun Nov 26 02:52:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-93552 O1:(3002E) vi I SO 3002 All irhgts seredevr Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepa
14、ring 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 and non-governmental, in l
15、iaison 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 Directives, Part 2. The main task o
16、f 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 casting a vote. Attention i
17、s 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. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent ri
18、ghts. ISO shall not be held responsible for identifying any or all such patent rights. ISO 25539-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants. ISO 25539 consists of the following parts, under the general title Cardiovascular impla
19、nts Endovascular devices: Part 1: Endovascular prostheses Part 2: Vascular stents Part 3: Vena cava filters BS ISO 255391:2003 iv Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-93552 O1:(3002E) I SO 3002 All irhgts seredevr v Introductio
20、n This part of ISO 25539 has been prepared in order to provide minimum requirements for endovascular prostheses and the methods of test that will enable their evaluation. It is the first part of a proposed three-part International Standard. ISO/TS 15539, from which this part of ISO 25539 is derived,
21、 serves as a rationale for the requirements. The Technical Specification was developed by first identifying the design requirements for endovascular implants and listing the potential implant and clinical failure modes. Tests were then identified to address each of the failure modes. The requirement
22、s provided in this part of ISO 25539 are based on that assessment. Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and clinical results are n
23、ot always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be undertaken. BS ISO 255391:2003 v Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:52:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun
24、 sheffieldun, na, Sun Nov 26 02:52:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS-93552 O1:(3002E) I SO 3002 All irhgts seredevr 1 Cardiovascular implants Endovascular devices Part 1: Endovascular prostheses 1 Scope 1.1 This part of ISO 25539 specifies requirements for endov
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