1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11608-3:2012Needle-based injection systems for medical use Requirements and test methodsPart 3: Finished containers (ISO 11608-3:2012)BS EN ISO 11608-3:2012 BRITISH STA
2、NDARDNational forewordThis British Standard is the UK implementation of EN ISO11608-3:2012. It supersedes BS EN ISO 11608-3:2001 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this com
3、mittee can beobtained 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 68887 4ICS 11.040.2
4、5Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE
5、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 containers (ISO 11608-3:2012) Systmes dinjection aiguille pour usage mdical - Exigences et mthodes dessai - P
6、artie 3: Conteneurs prts lemploi (ISO 11608-3:2012) Nadelbasierte 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/C
7、ENELEC 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 national standards may be obtained on application to the CEN-CENELEC Management Centr
8、e 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 language and notified to the CEN-CENELEC Management Centre has the same status as the
9、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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherla
10、nds, 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 Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploita
11、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11608-3:2012: EBS EN ISO 11608-3:2012EN ISO 11608-3:2012 (E) 3 Foreword This document (EN ISO 11608-3:2012) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal produ
12、cts 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 national standard, either by publication of an identical text or by endorsement, at the la
13、test 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 be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all suc
14、h 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 to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Eston
15、ia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The t
16、ext of ISO 11608-3:2012 has been approved by CEN as a EN ISO 11608-3:2012 without any modification. BS EN ISO 11608-3:2012ISO 11608-3:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepar
17、ing 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 represented on that committee. International organizations, governmental and non-governmental, in li
18、aison 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 drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of t
19、echnical 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 Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is dr
20、awn 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 11608-3 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intra
21、vascular catheters.This second edition cancels and replaces the first edition (ISO 11608-3:2000), which has been technically revised.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-based i
22、njection systems Part 2: Needles Part 3: Finished containers Part 4: Requirements and test methods for electronic and electromechanical pen-injectors Part 5: Automated functions ISO 2012 All rights reserved iiiBS EN ISO 11608-3:2012ISO 11608-3:2012(E)IntroductionThis part of ISO 11608 is applicable
23、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 interchangeabil
24、ity 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 Standard, particul
25、arly 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 labelling design
26、ation 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 latest revision of
27、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, this part of ISO 11
28、608 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 compatibility. However, t
29、hese 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 compatibility, it is helpful
30、 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 parameters and design c
31、riteria 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 ISO 11608 are i
32、ntended 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 and national sta
33、ndards, 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 if there are an
34、y other requirements relevant to the safety or marketability of their products.iv ISO 2012 All rights reservedBS EN ISO 11608-3:2012Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers1 ScopeThis part of ISO 11608 specifies the functional and desig
35、n considerations for containers to be used with needle-based injection systems (NIS) that 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
36、or assembled with the NIS at the time of use.This part of ISO 11608 includes specifications 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 use
37、d with a NIS.This part of ISO 11608 is not applicable to cartridges intended for dental use.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
38、syringes).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 amendments) applies.ISO 10993-1, Biolo
39、gical evaluation of medical devices Part 1: Evaluation and testing within a risk management 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 injec
40、tion systemsISO 11608-2, Needle-based injection systems for medical use Requirements and 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 ap
41、ply. 3.1capcomponent which attaches the disc to the cartridge3.2cartridgeprimary container for the medicinal productINTERNATIONAL STANDARD ISO 11608-3:2012(E) ISO 2012 All rights reserved 1BS EN ISO 11608-3:2012ISO 11608-3:2012(E)3.3cylindermain body of the container3.4deliverable volumecontents of
42、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 forcebreak-loose forceforce required to dislodge
43、 the plunger from its resting position3.7labelidentification of the contents of the container3.8particle-free waterwater that has passed through 0,2 micron pore-size filter media3.9plungercomponent which seals one end of the container and interfaces with the plunger rod of the delivery device3.10plu
44、nger roddelivery device mechanism which advances the plunger to deliver the medicinal product3.11sustaining forceforce required to maintain constant plunger velocity through the cylinder3.12user packagingwhat is provided to the user with one or a collection of containers, in their unit packaging, of
45、 the same item and from the same manufacturing batch item, including the directions for use as appropriate3.13unit packagingindividual packaging of the container that maintains the sterility of the product2 ISO 2012 All rights reservedBS EN ISO 11608-3:2012ISO 11608-3:2012(E)12345Key1 disc2 cap3 cyl
46、inder4 label5 plungerFigure 1 Finished cartridge4 Requirements4.1 GeneralThese requirements apply to any container intended to be used with a NIS. When test methods and specifications are noted, they are included to assist manufacturers and suppliers in supporting the achievement of cross-platform c
47、ompatibility for compatible cartridges for use in NIS.All materials shall be compatible or resistant, or both, to the medicinal product to be injected with the NIS.NOTE The containers are cartridge-based or syringe-based and made of plastic or glass. The cartridges are used with needles (as specifie
48、d in ISO 11608-2). The syringes may have a staked-on needle, a luer, a luer lock or other special connector for needle attachment. ISO 2012 All rights reserved 3BS EN ISO 11608-3:2012ISO 11608-3:2012(E)4.2 Freedom from leakage4.2.1 All containersThe container shall be free from leakage when tested w
49、ith the NIS in accordance with ISO 11608-1.4.2.2 CartridgesCartridges shall not leak at the plunger or the disc when tested in accordance with the method given in 5.5.4.3 Plunger force4.3.1 All containersThe force to initiate and sustain plunger movement in the container shall not result in incomplete or inaccurate doses when tested with NIS in accordance with ISO 11608-1. Testing shall include containers that are at, or representative of, their end of shelf life.4.3.2 CartridgesThe initiating force for cartridges shall not e
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