1、January 2013 Translation by DIN-Sprachendienst.English price group 11No 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).IC
2、S 11.040.25!$g1“1936814www.din.deDDIN EN ISO 11608-3Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers (ISO 11608-3:2012);English version EN ISO 11608-3:2012,English translation of DIN EN ISO 11608-3:2013-01Kanlenbasierte Injektionssysteme zur me
3、dizinischen Verwendung Anforderungen und Prfverfahren Teil 3: Fertigbehlter (ISO 11608-3:2012);Englische Fassung EN ISO 11608-3:2012,Englische bersetzung von DIN EN ISO 11608-3:2013-01Systmes dinjection aiguille pour usage mdical Exigences et mthodes dessai Partie 3: Conteneurs prts lemploi (ISO 116
4、08-3:2012);Version anglaise EN ISO 11608-3:2012,Traduction anglaise de DIN EN ISO 11608-3:2013-01SupersedesDIN EN ISO 11608-3:2001-05www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 18 pages01.13 DIN EN ISO 11608-3:2013-01 2 A comma is u
5、sed as the decimal marker. National foreword This document (EN ISO 11608-3:2012) 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-active medical devices” (Secret
6、ariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-01 AA Injektionssysteme. The DIN Standards corresponding to the International Standards referred to in this document are as follows
7、: ISO 7864 DIN EN ISO 7864 ISO 7886-1 DIN EN ISO 7886-1 ISO 8537 DIN EN ISO 8537 ISO 9000 DIN EN ISO 9000 ISO 13485 DIN EN ISO 13485 ISO 10993-1 DIN EN ISO 10993-1 ISO 11040-3 DIN ISO 11040-3 ISO 13926-1 DIN ISO 13926-1 DIN EN ISO 11608 consists of the following parts, under the general title Needle
8、-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 functions Amendments This standard dif
9、fers from DIN EN ISO 11608-3:2001-05 as follows: a) the title of the German version has been changed to read Kanlenbasierte Injektionssysteme (instead of Nadelbasierte Injektionssysteme); b) the scope has been extended to include finished containers to be used with needle-based injection systems; c)
10、 new terms and definitions have been included in Clause 3: “3.8 particle-free water” and “3.12 user packaging”; d) Clause 4 “Requirements” has been revised and subdivided into requirements for all containers and for cartridges; Subclause 4.9 “Coring (fragmentation)” has been added; e) Clause 5 “Test
11、 methods” has been revised and restructured; the former Subclauses 5.4 “Analytical approach”, 5.11 “Dose accuracy (variable)” and 5.12 “Deliverable volume (attribute)” have been deleted to be in line with the modified scope; f) the standard has been editorially revised. Previous editions DIN EN ISO
12、11608-3: 2001-05 DIN EN ISO 11608-3:2013-01 3 National Annex NA (informative) Bibliography DIN ISO 11040, Prefilled syringes Glass cylinders for dental local anaesthetic cartridges DIN ISO 13926-1, Pen systems Part 1: Glass cylinders for pen-injectors for medical use DIN EN ISO 7864, Sterile hypoder
13、mic needles for single use DIN EN ISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manual use DIN EN ISO 8537, Sterile single-use syringes, with or without needle, for insulin DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 10993-1, Biolo
14、gical evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 11608-3:2013-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPIS
15、CHE NORM EN ISO 11608-3 October 2012 ICS 11.040.25 Supersedes EN ISO 11608-3:2000English Version Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containersSystmes dinjection aiguille pour usage mdical - Exigences et mthodes dessai - Partie 3: Contene
16、urs prts lemploi (ISO 11608-3:2012) Kanlenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prfverfahren - Teil 3: Fertigbehlter (ISO 11608-3:2012) This European Standard was approved by CEN on 29 September 2012. CEN members are bound to comply with the CEN/CENELEC Internal
17、 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 national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
18、 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 language and notified to the CEN-CENELEC Management Centre has the same status as the official versio
19、ns. 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Po
20、land, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. 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 11608-3:2012: EEUROPE
21、AN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG(ISO 11608-3:2012) Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references 5 3 Terms and definitions 5 4 Requirements . 7 4.1 General 7 4.2 Freedom from leakage . 8 4.2.1 All containers
22、 8 4.2.2 Cartridges . 8 4.3 Plunger force 8 4.3.1 All containers 8 4.3.2 Cartridges . 8 4.4 Dimensions . 8 4.4.1 All containers 8 4.4.2 Cartridges . 8 4.5 Eccentricity . 9 4.5.1 All containers 9 4.5.2 Cartridges . 9 4.6 Visibility of the medicinal product All containers 9 4.7 Meniscus Cartridge only
23、 . 9 4.8 Resealability All containers 9 4.9 Coring (fragmentation) 10 4.10 Container materials 10 4.10.1 All containers 10 4.10.2 Cartridges . 10 4.11 Cap Cartridge only 10 4.12 Plunger and disc Cartridge only 10 4.13 Particulates All containers . 10 4.14 Dose accuracy All containers 10 4.15 Deliver
24、able volume All containers . 10 4.16 Freedom from damage All containers . 10 5 Test methods 11 5.1 Test apparatus 11 5.2 Test conditions . 11 5.3 Test fluid . 11 5.4 Plunger force 11 5.5 Leakage (attribute) . 11 5.6 Dimensions . 12 5.6.1 Length reference, l312 5.6.2 Overall diameter, d6, and plunger
25、 insertion depth, h3. 12 5.6.3 Eccentricity (attribute) . 12 5.6.4 Meniscus (attribute) . 12 5.6.5 Resealability (attribute) . 12 5.6.6 Coring (variable) . 12 6 Information supplied by the manufacturer 13 Bibliography 14 2DIN EN ISO 11608-3:2013-01 EN ISO 11608-3:2012 (E) Foreword This document (EN
26、ISO 11608-3:2012) 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-active medical devices” the secretariat of which is held by DIN. This European Standard shall be
27、 given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Attention is drawn to the possibility that some of the elements of this document may
28、 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 11608-3:2000. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound
29、 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, Norway, Poland, Portugal,
30、 Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11608-3:2012 has been approved by CEN as a EN ISO 11608-3:2012 without any modification. “”3DIN EN ISO 11608-3:2013-01 EN ISO 11608-3:2012 (E) IntroductionThis part of ISO 1160
31、8 is applicable to containers that are provided pre-filled, or that are to be filled by the user with medicinal products intended by the manufacturer to be used with needle-based injection systems (NIS), as covered by ISO 11608.The previous edition of this part of ISO 11608 introduced the concept of
32、 interchangeability and the labelling designation of Type A (i.e. interchangeable) and non-Type A for needles and containers.Since its publication, experience has shown that the complexity of these systems makes it very difficult to ensure functional compatibility as defined in this International St
33、andard, particularly when products are made by different manufacturers and the design is not verified as a system. The “Type A” designation, therefore, does not represent adequate guidance to the user in making decisions on the compatibility of needles and containers with specific NIS. As such, the
34、labelling designation of “Type A” has been removed.The previous edition of this part of ISO 11608 also only addressed cartridges as the drug container. This was consistent with the scope of ISO 11608 (all parts), which was previously restricted to cartridge-based injection pens. The scope of the lat
35、est revision of ISO 11608 (all parts) has been expanded beyond pen injectors and now includes all NIS, resulting in additional possibilities for compatible containers, including syringes to be used with NIS, and potentially other containers not yet defined. In order to preserve this information, thi
36、s part of ISO 11608 maintains those specifications, requirements and dimensions. It is important to stress that the design requirements related to system function have been maintained as a guide to assist manufacturers during the design phase in supporting the achievement of cross-platform compatibi
37、lity. However, these design requirements are an insufficient replacement for system testing of the components and, where possible, direct communication and/or quality agreements between system component manufacturers. Given the patient convenience benefits associated with cross-platform compatibilit
38、y, it is helpful if manufacturers of needles, containers and NIS label their products with the specific system components that have been tested and demonstrated to be functionally compatible.For containers other than cartridges, this part of ISO 11608 can be used as a guide to understand the paramet
39、ers and design criteria to be considered in the selection and/or design of containers that will be used with NIS. It provides performance requirements regarding essential aspects so that variations of design are not unnecessarily restricted.The sampling plans for inspection selected for this part of
40、 ISO 11608 are intended for design verification at a high confidence level. The sampling plans for inspection do not replace the more general manufacturing quality systems that appear in standards on quality management systems, such as the ISO 9000 series and ISO 13485.There are other international
41、and national standards, guidance materials and, in some countries, national regulations that are applicable to medical devices and pharmaceuticals; their requirements might supersede or complement this part of ISO 11608. Developers and manufacturers of NIS are encouraged to investigate and determine
42、 if there are any other requirements relevant to the safety or marketability of their products.4DIN EN ISO 11608-3:2013-01 EN ISO 11608-3:2012 (E) 1 ScopeThis part of ISO 11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that
43、 fulfil the specifications of ISO 11608-1. It is applicable to single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the end-user integrated in the NIS or assembled with the NIS at the time of use.This part of ISO 11608 includes specificatio
44、ns and test methods to describe and evaluate cartridges for use in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential containers, including syringes to be used with a NIS.This part of ISO 11608 is not applicable to cartridges intended for dental u
45、se.Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this part of ISO 11608.NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).2 Normative referencesThe following referenced documents are indispensable for
46、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 amendments) applies.ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk manageme
47、nt processISO 11040-3, Prefilled syringes Part 3: Seals for dental local anaesthetic cartridgesISO 11608-1, Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systemsISO 11608-2, Needle-based injection systems for medical use Requirements and
48、test methods Part 2: NeedlesISO 13926-1:2004, Pen systems Part 1: Glass cylinders for pen-injectors for medical use3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply. 3.1capcomponent which attaches the disc to the cartridge3.2cartridgeprimary containe
49、r for the medicinal product5DIN EN ISO 11608-3:2013-01 EN ISO 11608-3:2012 (E) 3.3cylindermain body of the container3.4deliverable volumecontents of the container which are accessible by utilizing the delivery device in accordance with the instructions for useNOTE Deliverable volume can be less than fill volume.3.5disccomponent which seals the end of the container opposite the plunger3.6initiating forcebre
