DIN EN ISO 8537-2016 Sterile single-use syringes with or without needle for insulin (ISO 8537 2016) German version EN ISO 8537 2016《胰岛素用有或无针头一次性无菌注射器(ISO 8537-2016) 德文版本EN ISO 8537.pdf

1、November 2016 English price group 17No 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 11.040.25!%YM“2585442www.din.de

2、DIN EN ISO 8537Sterile singleuse syringes, with or without needle, for insulin (ISO 8537:2016);English version EN ISO 8537:2016,English translation of DIN EN ISO 8537:2016-11Sterile InsulinEinmalspritzen mit oder ohne Kanle (ISO 8537:2016);Englische Fassung EN ISO 8537:2016,Englische bersetzung von

3、DIN EN ISO 8537:2016-11Seringues insuline, striles, non rutilisables, avec ou sans aiguille (ISO 8537:2016);Version anglaise EN ISO 8537:2016,Traduction anglaise de DIN EN ISO 8537:2016-11SupersedesDIN EN ISO 8537:200810www.beuth.deDocument comprises 40 pagesDTranslation by DIN-Sprachendienst.In cas

4、e of doubt, the German-language original shall be considered authoritative.10.16 DIN EN ISO 8537:2016-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 8537:2016) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products an

5、d catheters” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02

6、-01 AA Injektionssysteme. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3696 DIN ISO 3696 ISO 7864 DIN EN ISO 7864 ISO 9626 DIN EN ISO 9626 ISO 10993-1 DIN EN ISO 10993-1 ISO 11608-1 DIN EN ISO 11608-1 ISO 11608-5 DIN EN ISO 11608-5 I

7、SO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 23908 DIN EN ISO 23908 ISO/IEC 80369-7 E DIN EN ISO/IEC 80369-7 Amendments This standard differs from DIN EN ISO 8537:2008-10 as follows: a) the Introduction has been revised; b) the scope of the standard has been revised to include variou

8、s concentrations of insulin and specified plastic materials; single-use syringes made of glass have been excluded; c) some normative references have been added; d) new terms and definitions have been included; e) new colour codes for higher concentrations of insulin have been added; f) the drawing i

9、llustrating the components of the syringe has been improved; g) general requirements have been added; h) the test methods for syringes have been revised; i) the marking requirements have been revised; j) syringe sizes and graduated scales have been moved to Annex H; k) the former Annex I has been de

10、leted. DIN EN ISO 8537:2016-11 3 Previous editions DIN 13098-3: 1989-07 DIN EN ISO 8537: 1994-09, 2001-03, 2008-10 DIN EN ISO 8537:2016-11 4 National Annex NA (informative) Bibliography DIN EN ISO 7864, Sterile hypodermic needles for single use DIN EN ISO 9626, Stainless steel needle tubing for manu

11、facture of medical devices DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 11608-1, Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems DIN EN ISO 11

12、608-5, Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and informa

13、tion to be supplied Part 1: General requirements DIN EN ISO 23908, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling E DIN EN ISO 80369-7, Small bore connectors for liquid

14、s and gases in healthcare applications Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications DIN ISO 3696, Water for analytical laboratory use Specification and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8537 April 2016 ICS 11.040.20 Superse

15、des EN ISO 8537:2008English Version Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) Seringues insuline, striles, non rutilisables, avec ou sans aiguille (ISO 8537:2016) Sterile Insulin-Einmalspritzen mit oder ohne Kanle (ISO 8537:2016) This European Standard was appr

16、oved by CEN on 27 February 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 alteration. Up-to-date lists and bibliographical references concerning such nation

17、al 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 translation under the responsibility of a CEN member into its own languag

18、e 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, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, H

19、ungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-C

20、ENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8537:2016 EForeword 8Introduction 91 Scope 102 Normative references . 103 Terms and definitions 114 Types of syrin

21、ges . 145 Requirements . 145.1 General requirements 145.2 Material selection 155.3 Colour coding 155.4 Extraneous matter 165.4.1 General. 165.4.2 Limits for acidity or alkalinity . 165.4.3 Limits for extractable metals 165.5 Lubrication 165.5.1 Lubrication of syringes 165.5.2 Lubrication of needle t

22、ube . 175.6 Dimensions 175.6.1 Barrel and plunger stopper . 175.6.2 Finger grips . 175.7 Plunger/plunger stopper . 175.7.1 General. 175.7.2 Fit of plunger stopper in barrel 175.8 Nozzle. 175.8.1 Conical fitting . 175.8.2 Position of nozzle on end of barrel 175.9 Needle tubing and needles 185.9.1 Nee

23、dles for syringe types 3 and 4 185.9.2 Needle tubing for syringe types 5, 6, 7 and 8 . 185.9.3 Bond between hub and needle tube 185.10 Standard test environmental conditions . 185.11 Performance of assembled syringe 185.11.1 Dead space . 185.11.2 Freedom from leakage at needle . 195.11.3 Freedom fro

24、m leakage past plunger stopper .196 Packaging 196.1 Unit packaging and self-contained syringe units .196.1.1 General. 196.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7) .196.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8) 196.2 Multiple-unit pack

25、aging (for syringe types 2, 4, 6 and 8) .206.3 User packaging . 20Contents PageEuropean foreword 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC 6 .DIN EN ISO 8537:2016-11 EN ISO 8537:2016

26、(E) 2 Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals .24Annex B (normative) Test method for air leakage past syringe piston during aspiration and for separation of rubber stopper and plunger .25Annex C (normative) Test method for determination of forces requ

27、ired to operate piston .27Annex D (normative) Test method for determination of dead space 29Annex E (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub or needle/barrel unions during compression 30Annex F (normative) Test method for air leakage past nozzle/hub or need

28、le/barrel unions during aspiration 32Annex G (normative) Preparation of extract for test for pyrogenicity and toxicity .33Annex H (normative) Syringe sizes and graduated scales 34Bibliography .367 Information supplied by the manufacturer 207.1 General 207.2 Syringes 207.2.1 General. 207.2.2 Addition

29、al marking for self-contained syringes (syringe types 2, 4, 6 and 8) .217.3 Unit packaging (for syringe types 1, 3, 5 and 7) 217.4 Multiple unit packs (syringe types 2, 4, 6 and 8) .217.5 User packaging . 227.6 Storage container . 237.7 Transport wrapping 23DIN EN ISO 8537:2016-11 EN ISO 8537:2016 (

30、E)3 European foreword This document (EN ISO 8537:2016) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and catheters“ in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This E

31、uropean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2016, and conflicting national standards shall be withdrawn at the latest by October 2016. Attention is drawn to the possibility that some of the

32、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 8537:2008. This document has been prepared under a mandate given to CEN by the European Commission and the Eu

33、ropean Free Trade Association, and supports essential requirements of 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

34、 countries are bound to implement this European Standard: Austria, Belgium, 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, Norwa

35、y, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) app

36、lies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-

37、of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced docume

38、nts are cited in normative requirements determines the extent (in whole or in part) to which they apply. DIN EN ISO 8537:2016-11 EN ISO 8537:2016 (E) 4 Table Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equival

39、ent dated standard EN ISO or IEC ISO 594-1 EN ISO 594-1:1986 ISO 594-1:1986 ISO 7864 EN ISO 7864:1995* ISO 7864:1993* ISO 9626 EN ISO 9626:1995* ISO 9626:1991* ISO 14971 EN ISO 14971:2012 ISO 14971 ISO 62366-1 EN ISO 62366-1:2015 IEC 62366-1:2015 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 ISO

40、10993-1 EN ISO 10993-1:2009 ISO 10993-1:2003 ISO 80369-7 EN ISO 80369-7:2016* ISO 80369-7:2016* * New versions expected end of 2015. * Expected 2016. Endorsement notice The text of ISO 8537:2016 has been approved by CEN as EN ISO 8537:2016 without any modification. DIN EN ISO 8537:2016-11 EN ISO 853

41、7:2016 (E)5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associ

42、ation to provide a means of conforming to the Essential Requirements of Directive 93/42/EEC. Once this standard is 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 normative clau

43、ses 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. NOTE 1 Where a reference from a clause of this standard to the risk manageme

44、nt process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding es

45、sential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword,

46、 replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/subclause(s) of this European Standa

47、rd Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 5.1 m 7.1 6.1.2 c, 6.1.3 c, 6.2 b 7.2 5.2, 5.4 7.3 5.11.2, 5.11.3 7.5 6.1 7.6 6.1.2, 6.1.3, 7.2.2, 7.3, 7.4 8.3 5.1 n 8.4 5.1, 5.4, 5.6, 5.7, 7.3 g, 7.4 h, 7.5 h, 7.6 f 9.2 5.1 e, 5.1 g 10.1 5.1 e, 5.2 10.2 5.1 f 10.3 DI

48、N EN ISO 8537:2016-11 EN ISO 8537:2016 (E) 6 Clause 7 13.1 Clause 7 13.2 7.2.1, 7.2.2, 7.3, 7.4, 7.5, 7.6, 7.7 13.3 7.2.1 b, 7.3 e, 7.4 g 13.4 7.4, 7.5, 7.6 13.6 The information is provided on the packaging and no additional instruction for use is required WARNING Other requirements and other EU Directives may be applicable to the product(s) falling