DIN EN ISO 8362-2-2016 Injection containers and accessories - Part 2 Closures for injection vials (ISO 8362-2 2015) German version EN ISO 8362-2 2015《注射容器和附件 第2部分 注射瓶用瓶塞(ISO 8362-2.pdf

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1、February 2016 English price group 10No 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 11.040.20!%LS+“2414808www.din.d

2、eDIN EN ISO 8362-2Injection containers and accessories Part 2: Closures for injection vials (ISO 8362-2:2015);English version EN ISO 8362-2:2015,English translation of DIN EN ISO 8362-2:2016-02Injektionsbehltnisse und Zubehr Teil 2: Stopfen fr Injektionsflaschen (ISO 8362-2:2015);Englische Fassung E

3、N ISO 8362-2:2015,Englische bersetzung von DIN EN ISO 8362-2:2016-02Rcipients et accessoires pour produits injectables Partie 2: Bouchons pour flacons (ISO 8362-2:2015);Version anglaise EN ISO 8362-2:2015,Traduction anglaise de DIN EN ISO 8362-2:2016-02SupersedesDIN EN ISO 8362-2:2010-12www.beuth.de

4、Document comprises 15 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.16 DIN EN ISO 8362-2:2016-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 8362-2:2015) has been prepared by Technical

5、Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” 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-

6、Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-15 AA Gummi. DIN EN ISO 8362, Injection containers and accessories consists of the following parts: Part 1: Injection vials made of glass tubing Part 2: Closures for injection vials Part 3: Aluminium caps for inj

7、ection vials Part 4: Injection vials made of moulded glass Part 5: Freeze drying closures for injection vials1) Part 6: Caps made of aluminium-plastics combinations for injection vials Part 7: Injections caps made of aluminium-plastics combinations without overlapping plastics parts The DIN Standard

8、s corresponding to the International Standards referred to in this document are as follows: ISO 48 DIN ISO 48 ISO 3302-1 DIN ISO 3302-1 ISO 3302-2 DIN ISO 3302-22)ISO 7619-1 DIN ISO 7619-1 ISO 8871-1 DIN EN ISO 8871-1 ISO 8871-4 DIN EN ISO 8871-4 ISO 8871-5 DIN EN ISO 8871-5 ISO 15378 DIN EN ISO 153

9、78 Amendments This standard differs from DIN EN ISO 8362-2:2010-12 as follows: a) particulate contamination requirements have been specified; b) the standard has been editorially revised. Previous editions DIN 58367-1: 1975-08, 1984-04, 1986-04 DIN 58366-2: 1978-08, 1982-07 DIN ISO 8362-2: 1989-12 D

10、IN EN ISO 8362-2: 2010-12 1) This Standard has not been published as a European Standard. 2) DIN ISO 3302-2:1999-10 was withdrawn in 2010-02 without replacement. DIN EN ISO 8362-2:2016-02 3 National Annex NA (informative) Bibliography DIN ISO 48, Rubber, vulcanized or thermoplastic Determination of

11、hardness (hardness between 10 IRHD and 100 IRHD) DIN ISO 3302-1, Rubber Tolerances for products Part 1: Dimensional tolerances DIN ISO 3302-2, Rubber Tolerances for products Part 2: Geometrical tolerances2)DIN ISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part

12、 1: Durometer method (Shore hardness) DIN EN ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates DIN EN ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements a

13、nd test methods DIN EN ISO 8871-5, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing DIN EN ISO 15378, Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to

14、 Good Manufacturing Practice (GMP) DIN EN ISO 8362-2:2016-02 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-2 October 2015 ICS 11.040.20 Supersedes EN ISO 8362-2:2010English Version Injection containers and accessories - Part 2: Closures for injectio

15、n vials (ISO 8362-2:2015) Rcipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons (ISO 8362-2:2015) Injektionsbehltnisse und Zubehr - Teil 2: Stopfen fr Injektionsflaschen (ISO 8362-2:2015) This European Standard was approved by CEN on 29 August 2015. CEN members are bo

16、und 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 national standards may be obtained on application to the

17、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 language and notified to the CEN-CENELEC Management Centre

18、 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

19、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 B

20、russels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8362-2:2015 EEuropean foreword 3Introduction .51 Scope 62 Normative references . 63 Classification . 64 Shape and dimensions . 75 Designation . 86 Material . 87 Perfo

21、rmance requirements 97.1 General 97.2 Physical requirements . 97.2.1 Hardness 97.2.2 Penetrability . 97.2.3 Fragmentation . 97.2.4 Self-sealing and aqueous solution tightness test 97.2.5 Dye solution tightness test . 97.2.6 Resistance to ageing . 97.3 Chemical requirements. 97.4 Biological requireme

22、nts . 97.5 Particulate contamination requirements . 108 Labelling 10Bibliography 11Contents PageDIN EN ISO 8362-2:2016-02 EN ISO 8362-2:2015 (E) 2Foreword .4European foreword This document (EN ISO 8362-2:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection eq

23、uipment for medical and pharmaceutical use“. 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 April 2016, and conflicting national standards shall be withdrawn at the latest by April 2016. Attentio

24、n 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 8362-2:2010. According to the CEN-CENELEC Internal Regulations

25、, 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

26、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8362-2:2015 has been approved by CEN as EN ISO 8362-2:2015 without any modification. DIN EN ISO 8362-

27、2:2016-02 EN ISO 8362-2:2015 (E) 3 ForewordISO (the International Organization for Standardization) is 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 int

28、erested 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 liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnic

29、al Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO docu

30、ments should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). 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 responsi

31、ble for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given fo

32、r the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL

33、: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This third edition cancels and replaces the second edition (ISO 8362-2:2008), which has been technica

34、lly revised in order to include a new 7.5 particulate contamination requirements.ISO 8362 consists of the following parts, under the general title Injection containers and accessories: Part 1: Injection vials made of glass tubing Part 2: Closures for injection vials Part 3: Aluminium caps for inject

35、ion vials Part 4: Injection vials made of moulded glass Part 5: Freeze drying closures for injection vials Part 6: Caps made of aluminium-plastics combinations for injection vials Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics partDIN EN ISO 8362-2:2016-0

36、2 EN ISO 8362-2:2015 (E) 4 IntroductionThe purpose of this part of ISO 8362 is to specify the shape and dimensions of, and the requirements for, elastomeric closures intended for pharmaceutical use. Closures made from elastomeric materials are suitable primary packaging materials for parenteral prep

37、arations. In order to provide seal integrity of the container closure systems, the dimensions of the elastomeric closures have to be compatible with the dimensions of the glass vials and the caps as specified in corresponding parts of ISO 8362.Primary packaging components made of elastomeric materia

38、ls are an integral part of medicinal products and thus the principles of current Good Manufacturing Practices (cGMP) apply to the manufacturing of these components.Principles of cGMP are described in, for example, ISO 15378 or GMP Guidelines as published by the European Community and the United Stat

39、es of America.DIN EN ISO 8362-2:2016-02 EN ISO 8362-2:2015 (E) 5 1 ScopeThis part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.The dimensional requirements are not applicable to barr

40、ier-coated closures.Closures specified in this part of ISO 8362 are intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.2 Normative refere

41、ncesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO

42、48, Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)ISO 3302-1, Rubber Tolerances for products Part 1: Dimensional tolerancesISO 3302-2, Rubber Tolerances for products Part 2: Geometrical tolerancesISO 7619-1, Rubber, vulcanized or thermoplastic D

43、etermination of indentation hardness Part 1: Durometer method (Shore hardness)ISO 8362-1, Injection containers and accessories Part 1: Injection vials made of glass tubingISO 8362-4, Injection containers and accessories Part 4: Injection vials made of moulded glassISO 8871-1, Elastomeric parts for p

44、arenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavatesISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methodsISO 8871-5:2005, Elastomeric parts for parenterals and for devices for ph

45、armaceutical use Part 5: Functional requirements and testing3 ClassificationClosures for injection vials shall be classified as follows: Type A: closures for injection vials without no-pop/blow-back feature; Type B: closures for injection vials with no-pop/blow-back feature.DIN EN ISO 8362-2:2016-02

46、 EN ISO 8362-2:2015 (E) 6 4 Shape and dimensions4.1 The shape and dimensions of closures shall be as shown in Figure 1 and as given in Table 1. Figure 1 illustrates two types of closures, Types A and B.Dimensions in millimetresa) Type Ab) Type BKey1 no-pop/blow-back featureaInner diameter shall not

47、be wider than inner lumen.Figure 1 Dimensions and configuration of Types A and B closuresDIN EN ISO 8362-2:2016-02 EN ISO 8362-2:2015 (E) 7 Table 1 Dimensions of injection closuresDimensions in millimetresType Nomi-nal sized10,15d2max.d30,2d40,2h1min.h20,25h3min.h4min.Injection vialsISO 8362-1 ISO 8

48、362-4A13 7, 50 5 12,5 6,2 2,00 2,0 1,5 2 R and 4 R 20 13,20 10 18,8 8,5 3,30 2,0 1,5 6 R to 30 R 5 H to 100 HB13 7,40 5 12,5 7,6 6,2 2,00 2,0 1,5 2 I to 10 I20 13,00 10 18,8 13,3 8,5 3,30 2,0 1,5 6 H to 100 H4.2 If not otherwise specified, general dimensional tolerances shall be in accordance with ISO 3302-1