BS-EN-ISO-11608-4-2007.pdf
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1、BRITISH STANDARD BS EN ISO 11608-4:2007 Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors The European Standard EN ISO 11608-4:2007 has the status of a British Standard ICS 11.040.20; 11.040.25 ? Licensed Copy: London South Bank Un
2、iversity, London South Bank University, Fri Oct 05 02:17:04 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 11608-4:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 September 2007 BSI 2007 ISBN 978 0 580 54214 5 National foreword
3、This British Standard is the UK implementation of EN ISO 11608-4:2007. It is identical to ISO 11608-4:2006. The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes. A list of organizations represented on this committee can be obtained on request to
4、its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licen
5、sed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:04 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11608-4 August 2007 ICS 11.040.25 English Version Pen-injectors for medical use - Part 4: Requirements and tes
6、t methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006) Stylos-injecteurs usage mdical - Partie 4: Exigences et mthodes dessai pour stylos-injecteurs lectroniques et lectro-mcaniques (ISO 11608-4:2006) Pen-Injektoren zur medizinischen Anwendung - Teil 4: Anforderungen an und
7、Prfverfahren fr elektronische und elektromechanische Pen-Injektoren (ISO 11608-4:2006) This European Standard was approved by CEN on 9 August 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of
8、 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 Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A vers
9、ion in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, De
10、nmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALI
11、SATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11608-4:2007: E Licensed Copy: London South Bank University, London South Bank Uni
12、versity, Fri Oct 05 02:17:04 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword The text of ISO 11608-4:2006 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” of the International Organization for Standardization (ISO)
13、and has been taken over as EN ISO 11608-4:2007 by Technical Committee CEN/TC 205 “Non-active 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
14、 by February 2008, and conflicting national standards shall be withdrawn at the latest by February 2008. 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 s
15、uch patent rights. ISO 11608-4 consists of the following parts under the general title “Pen-injectors for medical use”: Part 1: Pen-injectors - Requirements and test methods Part 2: Needles - Requirements and test methods Part 3: Finished cartridges - Requirements and test methods Part 4: Requiremen
16、ts and test methods for electronic and electromechanical pen-injectors According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estoni
17、a, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11608-4:2006 has been approved by CEN
18、 as EN ISO 11608-4:2007 without any modifications. EN ISO 11608-4:2007 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:04 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 11608-4:2006(E) INTERNATIONAL STANDARD ISO 11608-4 First edition 2006-
19、03-15 Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors Stylos-injecteurs usage mdical Partie 4: Exigences et mthodes dessai pour stylos-injecteurs lectroniques et lectro-mcaniques EN ISO 11608-4:2007 Licensed Copy: London South Ba
20、nk University, London South Bank University, Fri Oct 05 02:17:04 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:04 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scop
21、e . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Symbols and abbreviated terms . 2 5 General requirements. 2 6 Test conditions . 2 7 Preconditioning of pen-injectors 2 8 Reagent and apparatus 5 9 Determination of dose accuracy. 5 10 Freedom from defects 6 11 Determination of electromagne
22、tic compatibility. 7 12 Electrical safety. 7 13 Visual inspection 8 14 Functional inspection. 8 15 Test report . 8 16 Information supplied by the manufacturer 9 Bibliography. 10 EN ISO 11608-4:2007 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:17:04 GMT+00:
23、00 2007, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member bod
24、y 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 liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrote
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