DIN EN ISO 5840-2-2016 Cardiovascular implants - Cardiac valve prostheses - Part 2 Surgically implanted heart valve substitutes (ISO 5840-2 2015) German version EN ISO 5840-2 2015《.pdf
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1、May 2016 English price group 24No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.40!%SMS“2484248www.din.deDIN
2、EN ISO 5840-2Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015);English version EN ISO 5840-2:2015,English translation of DIN EN ISO 5840-2:2016-05Herz- und Gefimplantate Herzklappenprothesen Teil 2: Chirurgisch implantierter Herzk
3、lappenersatz (ISO 5840-2:2015);Englische Fassung EN ISO 5840-2:2015,Englische bersetzung von DIN EN ISO 5840-2:2016-05Implants cardiovasculaires Prothses valvulaires Partie 2: Prothse valvulaires implantes chirurgicalement (ISO 5840-2:2015);Version anglaise EN ISO 5840-2:2015,Traduction anglaise de
4、DIN EN ISO 5840-2:2016-05SupersedesDIN EN ISO 5840-2:2015-12www.beuth.deDocument comprises 65 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 5840-2:2016-05 2 A comma is used as the decimal marker. Start of app
5、lication The start of application of this standard is 2015-12-01. For DIN EN ISO 5840:2009-08 there is a transition period ending on 2018-09-30. National foreword This document (EN ISO 5840-2:2015) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 2 “Cardiov
6、ascular implants and extracorporeal systems” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards
7、 Committee Optics and Precision Mechanics), Working Committee NA 027-02-17-01 UA Herz- und Gefimplantate. The DIN Standards corresponding to the European and International Standards referred to in this document are as follows: ISO 5840-1:2015 DIN EN ISO 5840-1:2015 ISO 10993-1 DIN EN ISO 10993-1 ISO
8、 10993-2 DIN EN ISO 10993-2 ISO 14155:2011 DIN EN ISO 14155 ISO 14630:2012 DIN EN ISO 14630 ISO 14971 DIN EN ISO 14971 ISO 16061 DIN EN ISO 16061 ISO/IEC 17025:2005 DIN EN ISO/IEC 17025:2005 ISO 22442 (all parts) DIN EN ISO 22442 (all parts) Amendments This standard differs from DIN EN ISO 5840:2009
9、-08 as follows: a) the standard has been subdivided into three parts dealing with “general requirements”, “surgically implanted heart valve substitutes” and “heart valve substitutes implanted by transcatheter techniques”; b) the content has been updated and brought into line with Part 3 of the stand
10、ard, which has already been published; c) the standard has been editorially revised. Compared with DIN EN ISO 5840-2:2015-12, the following correction has been made to the revision: the transition period in the “Start of application” has been corrected. Previous editions DIN EN 12006-1: 1999-10 DIN
11、EN ISO 5840: 2006-03, 2009-08 DIN EN ISO 5840-2: 2015-12 a) DIN EN ISO 5840-2:2016-05 3 National Annex NA (informative) Bibliography 1 DIN EN ISO 5840-1:2015, Cardiovascular implants Cardiac valve prostheses Part 1: General requirements 2 DIN EN ISO 10993-1, Biological evaluation of medical devices
12、Part 1: Evaluation and testing within a risk management system 3 DIN EN ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements 4 DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice 5 DIN EN ISO 14630, Non-active sur
13、gical implants General requirements 6 DIN EN ISO 14971, Medical devices Application of risk management to medical devices 7 DIN EN ISO 16061, Instrumentation for use in association with non-active surgical implants General requirements 8 DIN EN ISO/IEC 17025, General requirements for the competence
14、of testing and calibration laboratories 9 DIN EN ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives DIN EN ISO 5840-2:2016-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5840-2 September 2015 ICS 11.040.40 Supersedes
15、EN ISO 5840:2009English Version Cardiovascular implants - Cardiac valve prostheses -Part 2: Surgically implanted heart valve substitutes(ISO 5840-2:2015) Implants cardiovasculaires - Prothses valvulaires - Partie 2: Prothse valvulaires implantes chirurgicalement (ISO 5840-2:2015) Herz- und Gefimplan
16、tate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO 5840-2:2015) This European Standard was approved by CEN on 24 July 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard t
17、he status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, Fre
18、nch, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria
19、, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey
20、 and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref
21、. No. EN ISO 5840-2:2015 EEuropean foreword .4Introduction . 61 Scope . 72 Normative references 73 Terms and definitions . 84 Abbreviations 105 Fundamental requirements . 106 Device description . 116.1 Intended use . 116.2 Design inputs . 116.2.1 Operational specifications 116.2.2 Performance specif
22、ications . 116.2.3 Packaging, labelling, and sterilization 126.3 Design outputs . 126.3.1 General. 126.4 Design transfer (manufacturing qualification) 126.5 Risk management 127 Design verification testing and analysis/design validation . 127.1 General requirements 127.2 In vitro assessment . 137.2.1
23、 Test conditions, sample selection, and reporting requirements . 137.2.2 Material property assessment 147.2.3 Hydrodynamic performance assessment 147.2.4 Structural performance assessment 167.2.5 Device MRI safety .177.2.6 Additional implant design evaluation requirements .177.2.7 Design specific te
24、sting 187.2.8 Simulated use.187.2.9 Human factors/usability assessment .187.3 Preclinical in vivo evaluation 187.3.1 Overall requirements 187.3.2 Methods 197.3.3 Test report 207.4 Clinical investigation . 217.4.1 General. 217.4.2 Statistical considerations 217.4.3 Distribution of subjects and invest
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