EN ISO 8536-11-2015 en Infusion equipment for medical use - Part 11 Infusion filters for single use with pressure infusion equipment《医用输液设备 第11部分 用压力设备输液的输液过滤器》.pdf
《EN ISO 8536-11-2015 en Infusion equipment for medical use - Part 11 Infusion filters for single use with pressure infusion equipment《医用输液设备 第11部分 用压力设备输液的输液过滤器》.pdf》由会员分享,可在线阅读,更多相关《EN ISO 8536-11-2015 en Infusion equipment for medical use - Part 11 Infusion filters for single use with pressure infusion equipment《医用输液设备 第11部分 用压力设备输液的输液过滤器》.pdf(22页珍藏版)》请在麦多课文档分享上搜索。
1、BSI Standards PublicationBS EN ISO 8536-11:2015Infusion equipment for medicalusePart 11: Infusion filters for single use withpressure infusion equipmentBS EN ISO 8536-11:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO8536-11:2015. It supersedes BS EN IS
2、O 8536-11:2004 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a con
3、tract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 83295 6ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the auth
4、ority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-11 June 2015 ICS 11.040.20 Supersedes EN ISO 8536-11:2004English Version Infusion equipment for medical use - Part 11
5、: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)Matriel de perfusion usage mdical - Partie 11 : Filtres perfusion non rutilisables avec un matriel de perfusion sous pression (ISO 8536-11:2015) Infusionsgerte zur medizinischen Verwendung - Teil 11: Infusionsfilter
6、 zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-11:2015) This European Standard was approved by CEN on 16 April 2015. 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 s
7、tandard 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, French, German). A version i
8、n 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, Croatia, Cyprus, Czech
9、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 and United Kingdom. EURO
10、PEAN 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. No. EN ISO 8536-11:2015
11、 EBS EN ISO 8536-11:2015EN ISO 8536-11:2015 (E) 3 European foreword This document (EN ISO 8536-11:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“ in collaboration with Technical Committee CEN/TC 205 “Non-acti
12、ve medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn at the latest by D
13、ecember 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-11:2004. The former Clause 3 on des
14、ignation has been deleted; Clause 9 on labelling was amended by addition of information regarding the usage of the symbol “XXX” according ISO 7000, symbol 2725; Clause 10 on disposal has been added; A.4 has been amended; The former A.5 specifying a test for leakage of adapters with female and/or mal
15、e conical fittings has been deleted; Normative references and Bibliography have been updated; document has been editorially revised. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of
16、 EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Be
17、lgium, Bulgaria, 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, Swit
18、zerland, Turkey and the United Kingdom. BS EN ISO 8536-11:2015EN ISO 8536-11:2015 (E) 4 Endorsement notice The text of ISO 8536-11:2015 has been approved by CEN as EN ISO 8536-11:2015 without any modification. Table Correlations between undated normative references and dated EN and ISO standards Nor
19、mative references as listed in Clause 2 Equivalent dated standard EN ISO ISO 594-2 - ISO 594-2:1998 ISO 7000 - ISO 7000:2014 ISO 8536-8 EN ISO 8536-8:2015 ISO 8536-8:2015 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus Amd.1:2006 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 BS EN ISO 8536-
20、11:2015EN ISO 8536-11:2015 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade
21、 Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Membe
22、r State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this Euro
23、pean Standard and Directive 93/42/EEC on medical devices Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes Clause 3, Clause 4, 5.1, 5.2, 5.3, 5.4, 5.5 7.2 The part of ER 7.2 relating to packaging is not addressed. For packaging see Clause
24、8 of this standard. Clause 4, Clause 7 7.3 ER covered by biological evaluation. 5.3, 5.4, A.3, A.4 7.5 Only the first sentence is covered. Presumption of conformity with the Essential Requirements relating to the biological evaluation can only be provided if the manufacturer chooses to apply the ISO
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