DIN EN ISO 11608-5-2013 Needle-based injection systems for medical use - Requirements and test methods - Part 5 Automated functions (ISO 11608-5 2012) German version EN ISO 11608-5.pdf
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1、January 2013 Translation by DIN-Sprachendienst.English price group 12No 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).IC
2、S 11.040.25!$b“1939463www.din.deDDIN EN ISO 11608-5Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions (ISO 11608-5:2012);English version EN ISO 11608-5:2012,English translation of DIN EN ISO 11608-5:2013-01Kanlenbasierte Injektionssysteme zur med
3、izinischen Verwendung Anforderungen und Prfverfahren Teil 5: Automatisierte Funktionen (ISO 11608-5:2012);Englische Fassung EN ISO 11608-5:2012,Englische bersetzung von DIN EN ISO 11608-5:2013-01Systmes dinjection aiguille pour usage mdical Exigences et mthodes dessai Partie 5: Fonctions automatises
4、 (ISO 11608-5:2012);Version anglaise EN ISO 11608-5:2012,Traduction anglaise de DIN EN ISO 11608-5:2013-01www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 24 pages01.13 DIN EN ISO 11608-5:2013-01 2 A comma is used as the decimal marker.
5、National foreword This document (EN ISO 11608-5:2012) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The r
6、esponsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-01 AA Injektionssysteme. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 8537 DIN EN ISO 8537
7、ISO 9000 DIN EN ISO 9000 ISO 13485 DIN EN ISO 13485 ISO 14253-1 DIN EN ISO 14253-1 ISO 14971 DIN EN ISO 14971 ISO 16926-6 DIN ISO 16269-6 ISO 23908 DIN EN ISO 23908 DIN EN ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical use Requirements a
8、nd test methods: Part 1: Needle-based injection systems Part 2: Needles Part 3: Finished containers Part 4: Requirements and test methods for electronic and electromechanical pen-injectors Part 5: Automated functions DIN EN ISO 11608-5:2013-01 3 National Annex NA (informative) Bibliography DIN EN 60
9、068-2-30, Environmental testing Part 2-30: Tests Test Db: Damp heat, cyclic (12 h + 12 h cycle) DIN EN ISO 8537, Sterile single-use syringes, with or without needle, for insulin DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 13485, Medical devices Quality manageme
10、nt systems Requirements for regulatory purposes DIN EN ISO 14253-1, Geometrical product specifications (GPS) Inspection by measurement of workpieces and measuring equipment Part 1: Decision rules for proving conformance or non-conformance with specifications DIN EN ISO 14971, Medical devices Applica
11、tion of risk management to medical devices DIN ISO 16269-6, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals DIN EN ISO 23908, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers f
12、or catheters and needles used for blood sampling DIN EN ISO 11608-5:2013-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11608-5 October 2012 ICS 11.040.25 English Version Needle-based injection systems for medical use - Requirements and test methods -
13、Part 5: Automated functionsSystmes dinjection aiguille pour usage mdical - Exigences et mthodes dessai - Partie 5: Fonctions automatises (ISO 11608-5:2012) Verwendung - Anforderungen und Prfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2012) This European Standard was approved by CEN on
14、 29 September 2012. 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 alteration. Up-to-date lists and bibliographical references concerning such national standards
15、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 translation under the responsibility of a CEN member into its own language and notifie
16、d 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, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icela
17、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means r
18、eserved worldwide for CEN national Members. Ref. No. EN ISO 11608-5:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG(ISO 11608-5:2012) 1Kanlenbasierte Injektionssysteme zur medizinischen Contents Page Foreword . 3 Introduction . 4 1 Scope . 5
19、2 Normative references. 5 3 Terms and definitions 6 4 Requirements . 7 4.1 General requirements 7 4.2 Preparation . 8 4.3 Injection . 9 4.4 Risk analysis requirements . 12 5 Test methods 12 5.1 General 12 5.2 Dose specification requirements 15 5.3 Uncertainty of measurements and conformance with spe
20、cifications 16 6 Test report . 16 7 Information to be supplied by the manufacturer 16 Annex A (informative) Rationale for requirements . 17 Bibliography 19 2DIN EN ISO 11608-5:2013-01 EN ISO 11608-5:2012 (E) Annex ZA (informative) Relationship between this European Standard and the Essential Require
21、ments of EC Directive 93/42/EEC on medical devices 20 Foreword This document (EN ISO 11608-5:2012) has been prepared by Technical Committee ISO/TC 84 Devices for administration of medicinal products and intravascular catheters in collaboration with Technical Committee CEN/TC 205 “Non-active medical
22、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 April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Att
23、ention 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 has been prepared under a mandate given to CEN by the European Commission a
24、nd the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the follow
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