BS EN ISO 7886-3-2009 Sterile hypodermic syringes for single use - Auto-disable syringes for fixed-dose immunization《一次性使用无菌皮下注射器 固定剂量免疫接种用自动报废注射器》.pdf
《BS EN ISO 7886-3-2009 Sterile hypodermic syringes for single use - Auto-disable syringes for fixed-dose immunization《一次性使用无菌皮下注射器 固定剂量免疫接种用自动报废注射器》.pdf》由会员分享,可在线阅读,更多相关《BS EN ISO 7886-3-2009 Sterile hypodermic syringes for single use - Auto-disable syringes for fixed-dose immunization《一次性使用无菌皮下注射器 固定剂量免疫接种用自动报废注射器》.pdf(24页珍藏版)》请在麦多课文档分享上搜索。
1、BS EN ISO7886-3:2009ICS 11.040.25NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterile hypodermicsyringes for single usePart 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)This British Standardwas published underthe authority of theStand
2、ards Policy andStrategy Committee on 30November 2009. BSI 2009ISBN 978 0 580 67785 4Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 7886-3:2009National forewordThis British Standard is the UK implementation of EN ISO 7886-3:2009.It is identical to ISO 7886-3:2005. It supersedes
3、BS EN ISO 7886-3:2005which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the nece
4、ssary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7886-3 September 2009 ICS 11.040.25 Supersedes EN ISO 7886-3:2005English Version S
5、terile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) Seringues hypodermiques striles, non rutilisables - Partie 3: Seringues autobloquantes pour vaccination dose fixe (ISO 7886-3:2005) Sterile Einmalspritzen fr medizinische Zwecke -
6、Teil 3: Selbstblockierende Spritzen fr die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2005) This European Standard was approved by CEN on 24 August 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the
7、 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 Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, Germa
8、n). 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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Re
9、public, Denmark, 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
10、DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7886-3:2009: EBS EN ISO 7886-3:2009EN ISO 7886-3:2009 (E) 3 Foreword The
11、text of ISO 7886-3:2005 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) and has been taken over as EN ISO 7886-3:2009. This European Standard shall be given t
12、he status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the
13、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 7886-3:2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and
14、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 organizations of the following countries are bound to implement this Eu
15、ropean Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the Unit
16、ed Kingdom. Endorsement notice The text of ISO 7886-3:2005 has been approved by CEN as a EN ISO 7886-3:2009 without any modification. BS EN ISO 7886-3:2009EN ISO 7886-3:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/
17、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 Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is
18、 cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member 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 conformi
19、ty with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying re
20、marks/Notes 5 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered: protection against risks posed by the presence of phthalates and other toxic substances are not specifically addressed. 6 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered: protection against risks posed by the presence of phthalat
21、es and other toxic substances are not specifically addressed. 7 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered: protection against risks posed by the presence of phthalates and other toxic substances are not specifically addressed. 8 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered: protecti
22、on against risks posed by the presence of phthalates and other toxic substances are not specifically addressed. 9 10.1, 10.3 10 1, 10.1, 10.2, 10.3 11.1 1, 10.1, 10.211.2 10.2 12.1 1, 2, 3, 10.2, 12.8.2 12.2 1, 2, 3, 12.8.1, 12.8.2 12.3 10.2 13.1 1, 2BS EN ISO 7886-3:2009EN ISO 7886-3:2009 (E) 5 Tab
23、le ZA.1 (continued) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC 13.2 1, 2, 9.1 14.1 1, 2, 10.1, 10.3 14.2 1, 2, 7.5, 7.6 14.3 1, 2, 3, 12.8.2, 8.1 14.4 5 15.1 3, 7.2, 8.3, 8,7 15.2 7.2, 8.3, 8,7 16 13.1, 13.2, 13.3, 13.4, 13.5, 13.6 Except 13.3 (f) (second
24、phrase regarding indication of single use consistent across community), except 13.3 (a) (regarding representative in the Community), except 13.6 (h) 2ndphrase (information on known characteristics and technical factors known to manufacturer that could pose a risk if reused) and 13.6 (q) (regarding d
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