1、December 2012 Translation by DIN-Sprachendienst.English price group 13No 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).I
2、CS 11.040.25!$8“1929121www.din.deDDIN EN ISO 11608-2Needle-based injection systems for medical use Requirements and test methods Part 2: Needles (ISO 11608-2:2012);English version EN ISO 11608-2:2012,English translation of DIN EN ISO 11608-2:2012-12Kanlenbasierte Injektionssysteme zur medizinischen
3、Verwendung Anforderungen und Prfverfahren Teil 2: Kanlen (ISO 11608-2:2012);Englische Fassung EN ISO 11608-2:2012,Englische bersetzung von DIN EN ISO 11608-2:2012-12Systmes dinjection aiguille pour usage mdical Exigences et mthodes dessai Partie 2: Aiguilles (ISO 11608-2:2012);Version anglaise EN IS
4、O 11608-2:2012,Traduction anglaise de DIN EN ISO 11608-2:2012-12SupersedesDIN EN ISO 11608-2:2001-05www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.2511.12 DIN EN ISO 11608-2:2012-12 2 A comma is used as the decimal marker. Nationa
5、l foreword This standard 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 responsible German body involv
6、ed in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-01 AA Injektionssysteme. ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical use Requirements and test methods: Part 1: Needle-ba
7、sed 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 The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 2859-
8、1 DIN ISO 2859-1 ISO 7000 DIN ISO 7000 ISO 7864 DIN EN ISO 7864 ISO 9000 DIN EN ISO 9000 ISO 9626 DIN EN ISO 9626 ISO 10993-1 DIN EN ISO 10993-1 ISO 11608-1 DIN EN ISO 11608-1 ISO 11608-3 DIN EN ISO 11608-3 IEC 60068-2-30 DIN EN 60068-2-30 Amendments This standard differs from DIN EN ISO 11608-2:200
9、1-05 as follows: a) Clause 3 “Terms and definitions” has been revised: “3.1 NIS” and “3.4 user packaging” are new; b) Clause 4 “Requirements” has been revised; the designation “type A” has been deleted; c) Subclause 7.1 “General” has been included; d) Figure 2 “Test gauge for needles” has been updat
10、ed; e) the former Clause 10 “Unscrewing torque of the needle” has been deleted; the content of this clause has been included in the new Clause 11 “Test method for validating the compatibility of needles and injector systems”; f) Annex A “Determination of flow rate through needle” has been added; g)
11、the standard has been editorially revised. DIN EN ISO 11608-2:2012-12 3 Previous editions DIN EN ISO 11608-2: 2001-05 National Annex NA (informative) Bibliography DIN EN 60068-2-30, Environmental testing Part 2-30: Tests Test Db: Damp heat, cyclic (12 h 12 h cycle) DIN EN ISO 7864, Sterile hypodermi
12、c needles for single use DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 9626, Stainless steel needle tubing for manufacture of medical devices DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management syst
13、em 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 11608-3, Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers DIN ISO 2859-1, Sampling procedures
14、for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 11608-2:2012-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE
15、 NORM EN ISO 11608-2 April 2012 ICS 11.040.25 Supersedes EN ISO 11608-2:2000English Version Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012) Systmes dinjection aiguille pour usage mdical - Exigences et mthodes dessai - Partie 2: Aigu
16、illes Kanlenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prfverfahren - Teil 2: This European Standard was approved by CEN on 31 March 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europea
17、n Standard the 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-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (
18、English, French, German). 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-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgi
19、um, Bulgaria, Croatia, 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, Turkey and United Kingdom. EUROPE
20、AN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11608-2:2012: E(ISO 11608-
21、2:2012) Kanlen (ISO 11608-2:2012) Contents EN ISO 11608-2:2012 (E) DIN EN ISO 11608-2:2012-12 2 Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements .7 4.1 Materials .7 4.2 Dimensions .7 4.3 Determination of flow rate through the needle .7 4.4
22、Bond between hub and needle tube 7 4.5 Needle points .8 4.6 Freedom from defects .8 4.7 Lubrication .8 4.8 Dislocation of measuring point at the patient-end .8 4.9 Determination of functional compatibility with needle-based injection systems .8 4.10 Ease of assembly/disassembly 8 4.11 Sterility 8 5
23、Sampling .8 6 Pre-conditioning of needles .9 6.1 Pre-conditioning in dry heat atmosphere .9 6.2 Pre-conditioning in cold storage atmosphere 9 6.3 Pre-conditioning in cyclical atmosphere 9 7 Standard atmosphere and apparatus for tests .10 7.1 General 10 7.2 Standard test atmosphere 10 7.3 Test gauge
24、10 8 Determination of dislocation of measuring point at the patient-end .11 9 Bond between hub and needle tube 12 10 Packaging .12 11 Test method for needle/injector systems compatibility validation 12 11.1 Principle 12 11.2 Apparatus/equipment 13 11.3 Sample quantity requirements .13 11.4 Procedure
25、 .13 11.5 Acceptance criteria 15 11.6 Test report 16 12 Information supplied by the manufacturer .16 12.1 General 16 12.2 Marking .16 12.3 Instructions for use .18 Annex A (normative) Determination of flow rate through needle 19 Bibliography 21 Foreword This document (EN ISO 11608-2:2012) has been p
26、repared 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” the secretariat of which is held by DIN. This European Standard shall be given the status of a natio
27、nal standard, either by publication of an identical text or by endorsement, at the latest by October 2012, and conflicting national standards shall be withdrawn at the latest by October 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of paten
28、t rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11608-2:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europ
29、ean Standard: Austria, Belgium, Bulgaria, Croatia, 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, Turke
30、y and the United Kingdom. Endorsement notice The text of ISO 11608-2:2012 has been approved by CEN as a EN ISO 11608-2:2012 without any modification. “”EN ISO 11608-2:2012 (E) DIN EN ISO 11608-2:2012-12 3 IntroductionThis part of ISO 11608 covers sterile double-ended needles intended for single use
31、in conjunction with needle-based injection systems (e.g. pen injectors). These needles are often referred to as pen needles.The devices described in this part of ISO 11608 are designed to be used with the devices described in ISO 11608-1 and ISO 11608-3.The first edition of this part of ISO 11608 in
32、troduced the concept of interchangeability and the labelling designations “Type A” (i.e.interchangeable) and “non-Type A” for needles and container closure systems. Since its promulgation, experience has shown that the complexity of these systems makes it very difficult to ensure functional compatib
33、ility as defined in the different parts of this International Standard, particularly when products are made by different manufacturers and the design is not verified as a system. Based on this experience, it is believed that the Type A designation does not represent adequate guidance to the user in
34、making decisions on the compatibility of needles and container closures with specific needle-based injection systems (NIS). As such, the labelling designation “Type A” has been removed.This second edition of ISO 11608-2 addresses functional compatibility of the system through testing in accordance w
35、ith Clause 11. Flow rate is introduced as a new parameter. The sampling plans for inspection selected for this part of ISO 11608 are intended to verify, at a high confidence level, the manufacturers ability to manufacture one “lot” of needles that conforms to the critical product attributes. The sam
36、pling plans for inspection do not replace the more general manufacturing quality systems that appear in standards on quality systems, for example ISO 9000.This part of ISO 11608 does not specify requirements or test methods for freedom from biological hazards because no international agreement on th
37、e methodology and the pass/fail criteria has been reached. Guidance on biological tests relevant to double-ended needles is given in ISO 10993-1, and it is suggested that manufacturers take this guidance into account when evaluating products. Such evaluation should include the effects of the sterili
38、zation process. However, national regulations might exist in some countries, which might take precedence over the guidance in ISO 10993-1.In some countries, national regulations exist and their requirements might supersede or complement this part of ISO 11608.EN ISO 11608-2:2012 (E) DIN EN ISO 11608
39、-2:2012-12 4 1 ScopeThis part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.It is not applicable to: needles for dental use; pre-filled syringe needles; needle
40、s pre-assembled by the manufacturer; needles not requiring assembly or attachment to the NIS.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest editi
41、on of the referenced document (including any amendments) applies.ISO 7864:1993, Sterile hypodermic needles for single useISO 9626, Stainless steel needle tubing for the manufacture of medical devicesISO 11608-1, Needle-based injection systems for medical use Requirements and test methods Part 1: Nee
42、dle-based injection systemsIEC 60068-2-30:2005, Environmental testing Part 2-30: Tests Test Db: Damp heat, cyclic (12 h + 12 h cycle)3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1NISneedle-based injection systemsystem intended for parenteral a
43、dministration by injection of medicinal products using a multi-dose or single-dose containerSee Figure 1.EN ISO 11608-2:2012 (E) DIN EN ISO 11608-2:2012-12 5 l5l22l17l3d11l4h13456Key1 seal2 means of needle assembly attachment3 needle hub4 needle container5 needle shield (not required)6 needle tube7
44、jointing medium (if used)NOTE The needle container may serve as a needle shield.Figure 1 Example presentation of needle assembly for a NIS3.2sealremovable barrier which is intended to maintain the sterility of the needle inside the needle container3.3unit packagingneedle container, together with the
45、 seal forming the packaging of the device, that maintains the sterility of the needle3.4user packagingwhat is provided to the user with one or a collection of devices, in their unit packaging, of the same item and from the same manufacturing batchEN ISO 11608-2:2012 (E) DIN EN ISO 11608-2:2012-12 6
46、4 Requirements4.1 MaterialsThe needle shall be made of tubing materials specified in ISO 9626 or ISO 15510. The requirements in ISO 9626 apply.4.2 Dimensions4.2.1 GeneralThe dimensions of the needle assembly attachment part shall be such that the needle fits and functions with NISs that meet the req
47、uirements specified in 11608-1.The tubing characteristics used in needles shall meet the requirements of ISO 9626. If the tubing is not covered in that International Standard, the requirements for stiffness and breakage shall be adapted to corresponding requirements for the defined sizes.4.2.2 Dimen
48、sions for needlesNeedles shall fit the test apparatus specified in 7.3. Dimensions shall be in accordance with Table 1.Table 1 Dimensional requirements of needle assemblyMeasurements Dimensions mml1specified length 1,25l25,7 to 7,0l30,20 ml, the dose test is considered acceptable if the calculated values (of the collected dispensed fluid doses) are within 5 % of the targeted dose.Using the k factor corresponding to the sample size (i.e. n = 60, k = 2,67 for 95 % confidence an
