DIN EN ISO 8871-5-2017 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 Functional requirements and testing (ISO 8871-5 2016) German version EN ISO.pdf

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1、March 2017 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).ICS 11.040.20!%bVL“2635141www.din.deDI

2、N EN ISO 8871-5Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing (ISO 88715:2016);English version EN ISO 88715:2016,English translation of DIN EN ISO 8871-5:2017-03Elastomere Teile fr Parenteralia und fr Gerte zur pharmazeutischen Ve

3、rwendung Teil 5: Funktionelle Anforderungen und Prfung (ISO 88715:2016);Englische Fassung EN ISO 88715:2016,Englische bersetzung von DIN EN ISO 8871-5:2017-03lments en lastomre pour administration parentrale et dispositifs usage pharmaceutique Partie 5: Exigences fonctionnelles et essais (ISO 88715:

4、2016);Version anglaise EN ISO 88715:2016,Traduction anglaise de DIN EN ISO 8871-5:2017-03SupersedesDIN EN ISO 88715:201410www.beuth.deDocument comprises 19 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.02.17 DIN EN ISO 8871-5

5、:2017-03 2 National foreword This document (EN ISO 8871-5:2016) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 205

6、 “Non-active medical devices” (Secretariat: DIN, Germany), with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-15 AA Elastomere Pharmapackmittel und zu

7、gehrige Komponenten. DIN EN ISO 8871 consists of the following parts, under the general title Elastomeric parts for parenterals and for devices for pharmaceutical use: Part 1: Extractables in aqueous autoclavates Part 2: Identification and characterization Part 3: Determination of released-particle

8、count Part 4: Biological requirements and test methods Part 5: Functional requirements and testing The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 7864 DIN EN ISO 7864 ISO 8362-1 DIN EN ISO 8362-1 ISO 8362-3 DIN EN ISO 8362-3 ISO 8362-4

9、 DIN EN ISO 8362-4 ISO 8362-6 DIN EN ISO 8362-6 ISO 8536-2 DIN EN ISO 8536-2 ISO 8536-6 DIN ISO 8536-6 Amendments This standard differs from DIN EN ISO 8871-5:2014-10 as follows: a) subclauses 4.3 and 4.4 and Annexes C and D have been updated; b) the standard has been editorially revised. Previous e

10、ditions DIN ISO 8871-5: 2006-01 DIN EN ISO 8871-5: 2014-10 A comma is used as the decimal marker. DIN EN ISO 8871-5:2017-03 3 National Annex NA (informative) Bibliography DIN ISO 7864, Sterile hypodermic needles for single use Requirements and test methods DIN EN ISO 8362-1, Injection containers and

11、 accessories Part 1: Injection vials made of glass tubing DIN EN ISO 8362-3, Injection containers for injectables and accessories Part 3: Aluminium caps for injection vials DIN EN ISO 8362-4, Injection containers and accessories Part 4: Injection vials made of moulded glass DIN EN ISO 8362-6, Inject

12、ion containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials DIN EN ISO 8536-2, Infusion equipment for medical use Part 2: Closures for infusion bottles DIN EN ISO 8536-6, Infusion equipment for medical use Part 6: Freeze drying closures for infusion bottle

13、s DIN EN ISO 8871-5:2017-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8871-5 November 2016 ICS 11.040.20 Supersedes EN ISO 8871-5:2014English Version Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requir

14、ements and testing (ISO 8871-5:2016) lments en lastomre pour administration parentrale et dispositifs usage pharmaceutique - Partie 5: Exigences fonctionnelles et essais(ISO 8871-5:2016) Elastomere Teile fr Parenteralia und fr Gerte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderunge

15、n und Prfung (ISO 8871-5:2016) This European Standard was approved by CEN on 6 August 2016. CEN members are bound 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

16、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 (English, French, German). A version in any other language made by translation un

17、der 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, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former

18、 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EU

19、ROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8871-5:2016 EForeword .4Introduction .51 Scope . 62 Nor

20、mative references 63 Terms and definitions . 64 Requirements 74.1 Penetrability 74.2 Fragmentation . 74.3 Self-sealing and aqueous solution tightness . 74.4 Aqueous solution tightness 75 Preparation of elastomeric closures for testing 75.1 Sampling . 75.2 Cleaning . 75.3 Sterilization 7Annex A (norm

21、ative) Test for penetrability 8Annex B (normative) Test for fragmentation 9Annex C (normative) Test for self-sealing and dye solution tightness .11Annex D (normative) Test for dye solution tightness.13Bibliography .15Contents PageEN ISO 8871-5:2016 (E) DIN EN ISO 8871-5:2017-03 2European foreword .3

22、European foreword This document (EN ISO 8871-5:2016) has been prepared by Technical 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” the secre

23、tariat 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 May 2017 and conflicting national standards shall be withdrawn at the latest by May 2017. Attention is drawn to the

24、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 8871-5:2014. According to the CEN-CENELEC Internal Regulations, the national sta

25、ndards 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, Latvia, Lithuania,

26、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8871-5:2016 has been approved by CEN as EN ISO 8871-5:2016 without any modification. EN ISO 8871-5:2016 (E) DIN EN ISO

27、8871-5:2017-03 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 interested in a subje

28、ct 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 Electrotechnical Commission (IEC

29、) 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 documents should be no

30、ted. 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 responsible for identifying

31、 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 for the convenience of

32、 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: Foreword - Supplem

33、entary informationThe committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This second edition cancels and replaces the first edition (ISO 8871-5:2005), which has been technically revised.ISO 8871

34、 consists of the following parts, under the general title Elastomeric parts for parenterals and for devices for pharmaceutical use: Part 1: Extractables in aqueous autoclavates Part 2: Identification and characterization Part 3: Determination of released-particle count Part 4: Biological requirement

35、s and test methods Part 5: Functional requirements and testingEN ISO 8871-5:2016 (E) DIN EN ISO 8871-5:2017-03 4 IntroductionElastomeric or rubber closures for pharmaceutical use are used in combination with vials and many times in conjunction with piercing devices. There are three functional parame

36、ters which are important to the piercing process. These are penetrability, fragmentation and self-sealing. The three functional tests described in this part of ISO 8871 can be used as a reference method for testing elastomeric closures that are pierced using injection needles made from metal. In add

37、ition, the aqueous solution tightness test can be used to verify the effectiveness of the sealing of a specific closure/vial combination.EN ISO 8871-5:2016 (E) DIN EN ISO 8871-5:2017-03 5 1 ScopeThis part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric cl

38、osures used in combination with vials and when pierced by an injection needle.NOTE Functional testing with spikes is specified in ISO 8536-2 and in ISO 8536-6.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its

39、 application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 7864, Sterile hypodermic needles for single useISO 8362-1, Injection containers and accessories Part 1: Injection vials mad

40、e of glass tubingISO 8362-3, Injection containers and accessories Part 3: Aluminium caps for injection vialsISO 8362-4, Injection containers and accessories Part 4: Injection vials made of moulded glassISO 8362-6, Injection containers and accessories Part 6: Caps made of aluminium-plastics combinati

41、ons for injection vials3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1penetrabilityforce required for piercing an elastomeric closure3.2fragmentationmeasure of the number of elastomeric particles which are generated by the piercing process3.3se

42、lf-sealingmeasure of the resealing efficiency of elastomeric closures following penetration and withdrawal of a needle3.4aqueous solution tightnessmeasure for the effective sealing of a specific elastomeric closure/vial combinationEN ISO 8871-5:2016 (E) DIN EN ISO 8871-5:2017-03 6 4 Requirements4.1

43、PenetrabilityWhen tested in accordance with Annex A, the force required for piercing shall not be greater than 10 N for each closure.4.2 FragmentationWhen tested in accordance with Annex B, the number of elastomeric fragments per 48 piercings visible with the naked eye shall not be greater than 5.4.

44、3 Self-sealing and aqueous solution tightnessWhen tested in accordance with Annex C, none of the vials shall contain any trace of coloured solution when observed with the naked eye. This requirement applies to multi-dose containers only, i.e. containers which utilize elastomeric closures that are pi

45、erced multiple times.Materials that meet the requirements are not required to undergo further testing in accordance with 4.4.4.4 Aqueous solution tightnessWhen tested in accordance with Annex D, none of the vials shall contain any trace of coloured solution when observed with the naked eye.5 Prepara

46、tion of elastomeric closures for testing5.1 SamplingThe number of closures required for each test is as follows. Penetrability: 10 Fragmentation: 12 Self-sealing and aqueous solution tightness: 10 Aqueous solution tightness: 10In practice, it is recommended that more than the minimum required number

47、 of closures be prepared for testing.5.2 CleaningClosures shall be sterilized in the as-delivered condition. If samples from regular production cleaning processes are not available, the stoppers shall be cleaned in accordance with the following procedure.Introduce an appropriate number of rubber clo

48、sures in a suitable glass container, cover with particle-free water, boil for 5 min, then rinse five times with cold particle-free water.5.3 SterilizationThe closures shall be tested after having been subjected to the sterilization method actually used.EN ISO 8871-5:2016 (E) DIN EN ISO 8871-5:2017-03 7 Annex A (normative) Test for