1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11608-2:2012Needle-based injectionsystems for medical use Requirements and testmethodsPart 2: Needles (ISO 11608-2:2012)BS EN ISO 11608-2:2012 BRITISH STANDARDNational
2、forewordThis British Standard is the UK implementation of EN ISO11608-2:2012. It supersedes BS EN ISO 11608-2:2001 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can beo
3、btained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 69101 0ICS 11.040.25Compliance wi
4、th a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1160
5、8-2 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: Aiguilles (ISO 11608-
6、2:2012) Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prfverfahren - Teil 2: Nadeln (ISO 11608-2:2012) 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 conditi
7、ons 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 may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists i
8、n 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 notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standar
9、ds bodies of 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, Turkey
10、 and United Kingdom. EUROPEAN 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
11、 11608-2:2012: EBS EN ISO 11608-2:2012EN ISO 11608-2:2012 (E) 3 Foreword This document (EN ISO 11608-2:2012) 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-act
12、ive 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 by October 2012, and conflicting national standards shall be withdrawn at the latest by O
13、ctober 2012. 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 such patent rights. This document supersedes EN ISO 11608-2:2000. According to the CEN/CENELE
14、C Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
15、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey 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. BS EN ISO 11608-2:2012ISO 116
16、08-2:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative references . 13 Terms and definitions . 14 Requirements . 34.1 Materials . 34.2 Dimensions . 34.3 Determination of flow rate through the needle 34.4 Bond between hub and needle tube . 34.5 Needle
17、points 44.6 Freedom from defects 44.7 Lubrication 44.8 Dislocation of measuring point at patient end 44.9 Determination of functional compatibility with needle-based injection systems 44.10 Ease of assembly and disassembly . 44.11 Sterility . 45 Sampling 46 Pre-conditioning of needles . 56.1 Pre-con
18、ditioning in a dry-heat atmosphere . 56.2 Pre-conditioning in a cold-storage atmosphere . 56.3 Pre-conditioning in a cyclical atmosphere . 57 Standard atmosphere and apparatus for tests . 67.1 General . 67.2 Standard test atmosphere . 67.3 Test gauge . 68 Determination of dislocation of measuring po
19、int at patient end 79 Bond between hub and needle tube . 810 Packaging 811 Test method for validating the compatibility of needles and injector systems 811.1 Principle . 811.2 Apparatus and equipment . 911.3 Sample quantity requirements . 911.4 Procedure 911.5 Acceptance criteria . 1111.6 Test repor
20、t .1212 Information supplied by the manufacturer .1212.1 General .1212.2 Marking .1212.3 Instructions for use .14Annex A (normative) Determination of flow rate through needle 15Bibliography .17BS EN ISO 11608-2:2012ISO 11608-2:2012(E)ForewordISO (the International Organization for Standardization) i
21、s 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 body interested in a subject for which a technical committee has been established has the right to be represe
22、nted 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are dr
23、afted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International St
24、andard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 11608-2 was prepared
25、 by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters.This second edition cancels and replaces the first edition (ISO 11608-2:2000), which has been technically revised.ISO 11608 consists of the following parts, under the general title Needle-
26、based injection systems for medical use Requirements and 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 functionsiv ISO 2012 All rights reserve
27、dBS EN ISO 11608-2:2012ISO 11608-2:2012(E)IntroductionThis part of ISO 11608 covers sterile double-ended needles intended for single use 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 I
28、SO 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 introduced the concept of interchangeability and the labelling designations “Type A” (i.e.interchangeable) and “non-Type A” for needles and container closure systems
29、. Since its promulgation, experience has shown that the complexity of these systems makes it very difficult to ensure functional compatibility as defined in the different parts of this International Standard, particularly when products are made by different manufacturers and the design is not verifi
30、ed as a system. Based on this experience, it is believed that the Type A designation does not represent adequate guidance to the user in making decisions on the compatibility of needles and container closures with specific needle-based injection systems (NIS). As such, the labelling designation “Typ
31、e A” has been removed.This second edition of ISO 11608-2 addresses functional compatibility of the system through testing in accordance with 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
32、confidence level, the manufacturers ability to manufacture one “lot” of needles that conforms to the critical product attributes. The sampling plans for inspection do not replace the more general manufacturing quality systems that appear in standards on quality systems, for example ISO 9000.This par
33、t of ISO 11608 does not specify requirements or test methods for freedom from biological hazards because no international agreement on the 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 suggest
34、ed that manufacturers take this guidance into account when evaluating products. Such evaluation should include the effects of the sterilization process. However, national regulations might exist in some countries, which might take precedence over the guidance in ISO 10993-1.In some countries, nation
35、al regulations exist and their requirements might supersede or complement this part of ISO 11608. ISO 2012 All rights reserved vBS EN ISO 11608-2:2012BS EN ISO 11608-2:2012Needle-based injection systems for medical use Requirements and test methods Part 2: Needles1 ScopeThis part of ISO 11608 specif
36、ies 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; needles pre-assembled by the manufacturer; needles not
37、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 edition of the referenced document (including any amen
38、dments) 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: Needle-based injection systemsIEC 60068-2-30:2005, E
39、nvironmental 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 administration by injection of medicinal products
40、using a multi-dose or single-dose containerSee Figure 1.INTERNATIONAL STANDARD ISO 11608-2:2012(E) ISO 2012 All rights reserved 1BS EN ISO 11608-2:2012ISO 11608-2:2012(E)l5l22l17l3d11l4h13456Key1 seal2 means of needle assembly attachment3 needle hub4 needle container5 needle shield (not required)6 n
41、eedle tube7 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, toget
42、her with the 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 batch2 ISO 2012 All rights reservedBS EN ISO 1
43、1608-2:2012ISO 11608-2:2012(E)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 functio
44、ns with NISs that meet the requirements 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
45、 the defined sizes.4.2.2 Dimensions 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
46、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 and 97,5 % reliability), the following two conditions shall be met:SkSUL+ ()sdandSkSLL ()sdw
47、hereS is sample mean;Ssdis sample standard deviation;UL is upper specification limit;LL is lower specification limit. 11.5.4 The needle hub removal torque shall be less than 0,100 Nm. If the needle has no thread, applicable assembly and disassembly testing shall be adapted to the corresponding requi
48、rements.11.5.4.1 If three or more needles result in a peak (removal) torque of 0,100 Nm or more, the test is rejected. ISO 2012 All rights reserved 11BS EN ISO 11608-2:2012ISO 11608-2:2012(E)11.5.4.2 If zero, one or two needles result in a peak (removal) torque of 0,100 Nm or more, the test results
49、are accepted.11.6 Test reportThe test report shall contain at least the following information:a) date(s) of testing;b) identity of the NIS tested;c) identity of the needles tested;d) identity of the apparatus/equipment used for testing;e) identification of the test fluid/liquid/drug used for testing;f) temperature and relative humidity of the testing environment;g) measured results of the testing, including the needle hub removal torque and the dose accuracy data.12 Information supplied by the manufacturer12.1 Gener
