DIN EN ISO 7199-2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199 2016) German version EN ISO 7199 2017《心血管植入物和人工器官 血液-氧气交换机(氧合器)(IS.pdf
《DIN EN ISO 7199-2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199 2016) German version EN ISO 7199 2017《心血管植入物和人工器官 血液-氧气交换机(氧合器)(IS.pdf》由会员分享,可在线阅读,更多相关《DIN EN ISO 7199-2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199 2016) German version EN ISO 7199 2017《心血管植入物和人工器官 血液-氧气交换机(氧合器)(IS.pdf(28页珍藏版)》请在麦多课文档分享上搜索。
1、May 2017 English price group 14No 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!%d3“2659416www.din.deDIN E
2、N ISO 7199Cardiovascular implants and artificial organs Bloodgas exchangers (oxygenators) (ISO 7199:2016);English version EN ISO 7199:2017,English translation of DIN EN ISO 7199:2017-05Kardiovaskulre Implantate und knstliche Organe Blutgasaustauscher (Oxygenatoren) (ISO 7199:2016);Englische Fassung
3、EN ISO 7199:2017,Englische bersetzung von DIN EN ISO 7199:2017-05Implants cardiovasculaires et organes artificiels changeurs gaz/sang extracorporels (oxygnateurs) (ISO 7199:2016);Version anglaise EN ISO 7199:2017,Traduction anglaise de DIN EN ISO 7199:2017-05SupersedesDIN EN ISO 7199:201411www.beuth
4、.deDocument comprises 28 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.05.17 DIN EN ISO 7199:2017-05 2 A comma is used as the decimal marker. National foreword This document (DIN EN ISO 7199:2017) has been prepared by Technic
5、al Committee ISO/TC 150 “Implants for surgery” in collaboration with CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany), with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee
6、Medicine), Working Committee NA 063-01-03 AA “Extracorporeal circuits, equipment and disposables”. In addition to the legal units of measurement, this standard also uses the unit “psi”. It is important to note that according to the German law on units in metrology, the use of these units is not perm
7、itted in official or business communications within Germany. Conversion: Non-SI unit SI unit Conversion psi Pa 1 psi = 6 894,757 Pa The DIN Standards corresponding to the International Standards referred to in this document are follows: ISO 8637:2010 DIN EN ISO 8637 2014-03 ISO 10993-1 DIN EN ISO 10
8、993-1 ISO 10993-4 DIN EN ISO 10993-4 ISO 10993-7 DIN EN ISO 10993-7 ISO 10993-11 DIN EN ISO 10993-11 ISO 11135 DIN EN ISO 11135 ISO 11137-1 DIN EN ISO 11137-1 ISO 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 13485 DIN EN ISO 13485 ISO 17665-1 DIN EN ISO 17665-1 ISO 14971 DIN EN ISO
9、14971 Amendments This standard differs from DIN EN ISO 7199:2014-11 as follows: a) it has been specified that this standard is not applicable for separate arterial line filters; b) Clause 2 “Normative references” has been revised; c) terms have been specified for “integral arterial filters” and “fil
10、tration efficiency”; d) performance characteristics for integral arterial filters have been specified for the first time; e) the pressure for the determination of the integrity of blood pathways has been changed from 40 kPa to 150 kPa; f) requirements for filtration efficiency, flow rate of the inte
11、gral arterial filter and the air handling capability of the integral arterial filter have been specified for the first time. DIN EN ISO 7199:2017-05 3 Previous editions DIN EN 12022: 1999-03 DIN EN ISO 7199: 2014-11 National Annex NA (informative) Bibliography DIN EN ISO 8637:2014-03, Cardiovascular
12、 implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01) DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-4,
13、Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood DIN EN ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals DIN EN ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxici
14、ty DIN EN ISO 11135, Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validati
15、on and routine control of a sterilization process for medical devices DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part
16、 2: Validation requirements for forming, sealing and assembly processes DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine
17、control of a sterilization process for medical devices DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 7199:2017-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7199 January 2017 ICS 11.040.40 Supersedes EN
18、 ISO 7199:2014English Version Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016) Implants cardiovasculaires et organes artificiels - changeurs gaz/sang extracorporels (oxygnateurs) (ISO 7199:2016) Kardiovaskulre Implantate und knstliche Organe - Blutga
19、saustauscher (Oxygenatoren) (ISO 7199:2016)This European Standard was approved by CEN on 6 November 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteratio
20、n. 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, French, German). A version in any other language made by
21、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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, F
22、inland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR ST
23、ANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7199:2017 EForeword 10Introductio
24、n .111 Scope 122 Normative references . 123 Terms and definitions 134 Requirements . 144.1 Biological characteristics 144.1.1 Sterility and non-pyrogenicity 144.1.2 Biocompatibility 144.2 Physical characteristics 154.2.1 Blood pathway integrity . 154.2.2 Heat exchanger fluid pathway integrity 154.2.
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