BS EN ISO 8872-2003 Aluminium caps for transfusion infusion and injection bottles - General requirements and test methods《输血、输液及注射瓶的铝盖 一般要求和试验方法》.pdf

1、BRITISH STANDARD BS EN ISO 8872:2003 Incorporating Corrigendum No. 1 Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods The European Standard EN ISO 8872:2003 has the status of a British Standard ICS 11.040.20 BS EN ISO 8872:2003 This British Standar

2、d was published under the authority of the Standards Policy and Strategy Committee on 26 March 2003 BSI 11 June 2003 ISBN 0 580 41497 3 National foreword This British Standard is the official English language version of EN ISO 8872:2003. It is identical with ISO 8872:2003. It supersedes BS EN 28872:

3、1993 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which impleme

4、nt international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does

5、not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European

6、committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the

7、 EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 6, the Annex ZA page and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14519 Corrigendum No. 1 11 June 2003

8、Correction to EN ISO foreword page and incorporating the Annex ZA pageEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO8872 March2003 ICS11.040.20 SupersedesEN28872:1993 Englishversion Aluminiumcapsfortransfusion,infusionandinjectionbottles Generalrequirementsandtestmethods(ISO8872:2003) Capsules

9、enaluminiumpourflaconsdetransfusion, perfusionetinjectionSpcificationsgnraleset mthodesdessai(ISO8872:2003) AluminiumBrdelkappenfrTransfusions,Infusionsund InjektionsflaschenAllgemeineAnforderungenund Prfverfahren(ISO8872:2003) ThisEuropeanStandardwasapprovedbyCENon11March2003. CENmembersareboundtoc

10、omplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropean

11、Standardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepubli

12、c,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,SlovakRepublic,Spain,Sweden,Switzerland and UnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36

13、B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO8872:2003ECORRECTED20030514 Foreword Thisdocument(ENISO8872:2003)hasbeenpreparedbyTechnicalCommitteeISO/TC76 “Transfusion,infusionandinjectionequipmentformedicalandpharmaceuticalus

14、e“in collaborationwithCMC. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbySeptember2003,andconflictingnational standardsshallbewithdrawnatthelatestbySeptember2003. ThisdocumentsupersedesENISO28872:1993. AccordingtotheCEN

15、/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,Switzerl

16、andand theUnitedKingdom. Endorsementnotice ThetextofISO8872:2003hasbeenapprovedbyCENasENISO8872:2003withoutany modifications. NOTENormativereferencestoInternationalStandardsarelistedinAnnexZA(normative). ENISO8872:2003 Reference number ISO 8872:2003(E)INTERNATIONAL STANDARD ISO 8872 Second edition 2

17、003-03-15 Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods Capsules en aluminium pour flacons de transfusion, perfusion et injection Spcifications gnrales et mthodes dessai ENISO8872:2003ENISO8872:2003iiIS:2788 O3002(E) I SO 3002 All irhgts seredev

18、r iiiForeword ISO (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 subject for whic

19、h 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) on all ma

20、tters of electrotechnical standardization. International Standards are drafted 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 circ

21、ulated 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 drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held respons

22、ible for identifying any or all such patent rights. ISO 8872 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 8872:1988), which has been technically revised

23、. ENISO8872:2003iiiIS:2788 O3002(E) vi I SO 3002 All irhgts seredevrIntroduction This International Standard specifies requirements for aluminium caps for vials and bottles in the field of transfusion, infusion and injection. The primary materials from which containers, including their elastomeric c

24、losures, are made have to be suitable for the storage of such products until the products are administered. However, in this International Standard, aluminium caps are not considered as primary packaging materials that will come into direct contact with pharmaceutical preparations or blood. ENISO887

25、2:2003ivINTENRATIONAL TSANDADR IS:2788 O3002(E)I SO 3002 All irhgts seredevr 1Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods 1 Scope This International Standard specifies general requirements and test methods for aluminium caps for injection vial

26、s, and for infusion and transfusion bottles. 2 Normative references The 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 am

27、endments) applies. ISO 6892:1998, Metallic materials Tensile testing at ambient temperature ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibration of the force-measuring system ISO 8362-3:2001, Injecti

28、on containers and accessories Part 3: Aluminium caps for injection vials ISO 8536-3:1999, Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles 3 Requirements 3.1 Wrought products 3.1.1 Mechanical characteristics The mechanical characteristics shall comply with the requireme

29、nts specified for the three grades A, B or C (see Table 1) and shall be tested in accordance with the test procedures described in 4.2. ENISO8872:20031IS:2788 O3002(E) 2 I SO 3002 All irhgts seredevrTable 1 Grades of mechanical characteristics Tensile strength R mN/mm 2Proof stress of non-proportion

30、al elongation R pN/mm 2Grade Alloy amin. max. min. A AlFeSi annealed or coated 100 150 80 B AlFeSi 130 170 110 C AlMnCu 140 180 120 aThese alloys present a selection of widely used aluminium alloys for manufacture of caps. Other alloys are permitted, provided that they otherwise meet the requirement

31、s in this table. 3.1.2 Chemical composition The wrought (sheet and strip) used for the manufacture of caps shall be produced from aluminium alloy. The chemical composition shall be verified in accordance with 4.3. 3.2 Caps 3.2.1 Dimensions Aluminium caps shall comply with the dimensions and with the

32、 accepted tolerances as specified in the relevant International Standards. The thickness shall be measured in accordance with 4.4. 3.2.2 Contamination Aluminium caps shall be free from contamination; the presence of residual lubricants shall be reduced to an absolute minimum and burrs shall be avoid

33、ed. 3.2.3 Earing Aluminium caps should be free from earing defects at the cutting processing edge. If earing occurs, the earing defect, as measured in accordance with 4.5, shall not be greater than 3 %. 3.2.4 Crimping Aluminium caps shall fit properly when subjected to the crimping process as descri

34、bed in 4.6. 3.2.5 Resistance of caps 3.2.5.1 Seals that will be terminally steam-sterilized shall be crimped on a vial/closure combination in accordance with 4.6 and tested in accordance with 5.1. The seals shall show no signs of premature opening or deformation. 3.2.5.2 When measured in accordance

35、with the test method described in 4.7 and 4.8, the forces needed to remove the tabs or to tear them off completely shall comply with the limits specified in the relevant International Standards. ENISO8872:20032IS:2788 O3002(E) I SO 3002 All irhgts seredevr 3During removal, the complete tear-off tab

36、shall be torn off only as determined by the score path. When the test in accordance with 4.7 and 4.8 is carried out, no parts of aluminium caps shall break except the bridges and score paths. 3.2.5.3 Seals shall be crimped on a vial/closure combination in accordance with 4.6. When subjected to condi

37、tions as described in 5.2, the seals shall not show any visible alteration at the surface. NOTE Plain aluminium alloys have a tendency to produce spots during treatment in a steam sterilizer. 3.2.6 Coating When tested in accordance with 5.2, the lacquer on the caps which have been subjected to the t

38、ests described in 5.1 shall not show any sign of deterioration of the coating. 4 Test methods 4.1 General The tests shall be carried out on non-sterilized caps (except as specified in 3.2.5.1 and 3.2.5.3). 4.2 Mechanical characteristics The mechanical characteristics (tensile strength and proof stre

39、ss of non-proportional elongation) shall be determined in accordance with ISO 6892. 4.3 Chemical composition The analysis of chemical composition shall be carried out using an accepted method. The cap manufacturer may rely upon a certificate of conformity given by the supplier of the wrought product

40、. 4.4 Dimensions The dimensions shall be measured using an appropriate gauge or a micrometer. The thickness shall be measured at the top area where no deformation has occurred. For measurement of the inner diameter, the use of a pin gauge set or optical comparator is recommended. 4.5 Earing The eari

41、ng (see Figure 1) on the cutting/processing edges of the caps shall be calculated, as a percentage, by comparing the maximum and minimum total heights, measured on the external side, using the following equation: max min min 100 hh h where h maxis the maximum height of the external side of the cap w

42、here earing occurs; h minis the minimum height of the external side of the cap where earing occurs. ENISO8872:20033IS:2788 O3002(E) 4 I SO 3002 All irhgts seredevrNOTE Cross-section has been stylized to illustrate both the minimum and maximum heights, measured on the external side, where earing occu

43、rs. Figure 1 Illustration of earing on aluminium cap 4.6 Crimping Fill the glass containers with water to their nominal volume. Place the aluminium caps on a rubber closure fitted on bottles or vials. Crimp the cap by means of a crimping tool or a capping machine. 4.7 Test for resistance of bridges

44、for centre-tear tabs 4.7.1 Apparatus 4.7.1.1 Socket and punch, as shown in Figure 2. 4.7.1.2 Motorized loading device, capable of exerting a compressive force at a speed of 100 mm/min. 4.7.1.3 Compression dynamometer, class 1 in accordance with ISO 7500-1, load cell, or other device capable of measu

45、ring and recording the maximum compression load generated during the test. 4.7.2 Procedure Place the cap in the socket (4.7.1.1). Fit the motorized device (4.7.1.2) to the dynamometer (4.7.1.3), which in turn is fitted to the punch pushing the tab. Place all the elements so that they are submitted t

46、o an axial force exerted by the motorized device. 4.7.3 Expression of results Record the maximum value of the axial force necessary to break the first bridge. 4.8 Test for resistance of bridges and ability to remove tear-off tab completely 4.8.1 Apparatus 4.8.1.1 Motorized loading device, capable of

47、 exerting a tensile force at a speed of 100 mm/min. 4.8.1.2 Traction dynamometer, load cell, or other device capable of measuring and recording the maximum tensile load generated during the test. 4.8.2 Procedure The cap is placed in a device in accordance with Figure 3 and the tear-off tab is hung i

48、n a traction dynamometer in accordance with 4.8.1.2. 4.8.3 Expression of results The maximum force necessary for a tab to be completely torn off (tearing of incisions) shall be determined and recorded. ENISO8872:20034IS:2788 O3002(E) I SO 3002 All irhgts seredevr 5Dimensions in millimetres NOTE Dimensions and design of the punch should be adapted to the desig