DIN EN ISO 9187-1-2011 Injection equipment for medical use - Part 1 Ampoules for injectables (ISO 9187-1 2010) German version EN ISO 9187-1 2010《医用注射设备 第1部分 注射针药瓶(ISO 9187-1-2010) .pdf

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1、January 2011 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 11.040.20!$m,K“1740940www.din.deDDIN EN ISO 9187-1Injection equipment for medical use Part 1: Ampoules for injectables (ISO 9187-1:2010)English translation of DIN EN ISO 9187-1:2011-01Injektionsgerte zur medizinischen Verwendung Teil 1: Ampullen fr Injektionsprparate (ISO 9187-1:2010)Englische ber

3、setzung von DIN EN ISO 9187-1:2011-01Matriel dinjection usage mdical Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010)Traduction anglaise de DIN EN ISO 9187-1:2011-01SupersedesDIN EN ISO 9187-1:2008-06www.beuth.deDocument comprises pagesIn case of doubt, the German-language original sha

4、ll be considered authoritative.150 .11 2DIN EN ISO 9187-1:2011-01 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” (Secretariat: DIN, Germany)

5、 in collaboration with Technical Committee CEN/TC S02 “Transfusion equipment” (Secretariat: CCMC). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-03 AA Primr ackmittel-Behltnisse. DIN EN ISO 9187 cons

6、ists of the following parts, under the general title Injection equipment for medical use: Part 1: Ampoules for injectables Part 2: One-point-cut (OPC) ampoules The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 720 DIN ISO 720 ISO 2859-1 D

7、IN ISO 2859-1 ISO 7500-1 DIN EN ISO 7500-1 Amendments This standard differs from DIN EN ISO 9187-1:2008-06 as follows: a) the base radius, r, has been modified for the 10 ml, 20 ml, 25 ml and 30 ml glass; b) the standard has been editorially revised. Previous editions DIN 58377-1: 1977-05 DIN ISO 91

8、87-1: 1992-03, 2000-12 DIN EN ISO 9187-1: 2004-07, 2008-06 National Annex NA (informative) Bibliography DIN ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification DIN ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexe

9、d by acceptance quality limit (AQL) for lot-by-lot inspection DIN EN 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 pEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE N

10、ORM EN ISO 9187-1 October 2010 ICS 11.040.20 Supersedes EN ISO 9187-1:2008English Version Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010) Matriel dinjection usage mdical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010) Injektionsgerte zur medi

11、zinischen Verwendung - Teil 1: Ampullen fr Injektionsprparate (ISO 9187-1:2010) This European Standard was approved by CEN on 13 October 2010. 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 na

12、tional standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version i

13、n any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN 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

14、, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NOR

15、MALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9187-1:2010: EContents DIN EN ISO 9187-1:2011-01 EN ISO 9187-1:2010 (E) 2 Page

16、Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Dimensions and designation5 3.1 Dimensions.5 3.2 Designation 6 4 Material .6 5 Requirements.6 5.1 Hydrolytic resistance 6 5.2 Annealing quality.6 5.3 Breaking force6 6 Test for breaking force10 6.1 Principle10 6.2 Tensile testing machine

17、 10 6.3 Sampling.10 6.3.1 Number of samples10 6.3.2 Conditioning of samples.10 6.4 Procedure .10 6.5 Expression of results 11 6.6 Test report 11 7 Delivery .12 8 Packaging .12 9 Marking .12 Bibliography 13 Foreword The text of ISO 9187-1:2010 has been prepared by Technical Committee ISO/TC 76 “Trans

18、fusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 9187-1:2010 by Technical Committee CEN/TC S02 “Transfusion equipment” the secretariat of which is held by CCMC. This European Sta

19、ndard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2011, and conflicting national standards shall be withdrawn at the latest by April 2011. Attention is drawn to the possibility that some of the elements of thi

20、s 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 9187-1:2008. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countr

21、ies are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sloven

22、ia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9187-1:2010 has been approved by CEN as a EN ISO 9187-1:2010 without any modification. DIN EN ISO 9187-1:2011-01 EN ISO 9187-1:2010 (E) 3 Introduction Ampoules are suitable packaging materials for storing pharm

23、aceutical products until they are administered to the patient. Owing to the direct contact between injectables and the primary container over extended storage periods, possible interactions are to be avoided in order to guarantee patient safety. Adequate means to achieve this objective include prope

24、r selection of primary packaging materials, the choice of suitable package design and the availability of specific requirements and methods for testing individual container systems. In the past, four standardized forms of ampoule (forms A, B, C and D) have been in widespread use. However, form A is

25、no longer used in the pharmaceutical industry and consequently has not been included in this part of ISO 9187. To avoid any confusion among manufacturers and users, it was decided to retain the same designation letters (i.e. B, C and D) for the forms of ampoules in current use and to disregard the l

26、etter A. DIN EN ISO 9187-1:2011-01 EN ISO 9187-1:2010 (E) 4 1 Scope This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with

27、and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user. Ampoules complying with this part of ISO 9187 are intended for single use only. 2 Normative references The follo

28、wing 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 720, Glass Hydrolytic resistance of glass grains at 12

29、1 C Method of test and classification ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determinati

30、on by titration method and classification ISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/ compressi

31、on testing machines Verification and calibration of the force-measuring system 3 Dimensions and designation 3.1 Dimensions The dimensions of ampoules shall be as shown in Figures 1, 2 and 3 (forms B, C and D respectively) and as given in Table 1. DIN EN ISO 9187-1:2011-01 EN ISO 9187-1:2010 (E) 5 3.

32、2 Designation Designation of ampoules shall consist of the descriptor word “ampoule”, followed by a reference to this part of ISO 9187, followed by the ampoule form, the nominal volume, the colour of the glass and, if applicable, mention of a colour break-ring. EXAMPLE 1 Designation of a form B ampo

33、ule without colour break-ring with a nominal volume of 10 ml, made of colourless glass (cl) complying with the requirements of this part of ISO 9187: Ampoule ISO 9187-1 B 10 cl EXAMPLE 2 Designation of a form B ampoule with a colour break-ring (cbr) with a nominal volume of 10 ml, made of colourless

34、 glass (cl) complying with the requirements of this part of ISO 9187: Ampoule ISO 9187-1 B 10 cl cbr 4 Material Colourless (cl) or amber (br) glass of hydrolytic resistance grain class HGA 1, in accordance with ISO 720, shall be used. A change in the chemical composition of the glass material should

35、 be notified by the ampoule manufacturer to the user at least nine months in advance. 5 Requirements 5.1 Hydrolytic resistance When tested in accordance with ISO 4802-1 and ISO 4802-2, the hydrolytic resistance of the internal surface of ampoules shall comply with the requirements specified for hydr

36、olytic resistance container class HCT1 and HCF1 respectively 5.2 Annealing quality Ampoules shall be annealed; the maximum residual stress of uncoloured ampoules after annealing shall not produce an optical retardation exceeding 50 nm/mm of glass thickness. 5.3 Breaking force The breaking test shall

37、 be carried out on ampoules with a predetermined breaking point, such as a ceramic ring, at the constriction. When tested in accordance with Clause 6, the breaking force shall be as specified in Table 2. DIN EN ISO 9187-1:2011-01 EN ISO 9187-1:2010 (E) 6 Key 1 constriction 2 sealing point 3 stem 4 b

38、ulb 5 shoulder 6 base or bottom Key 1 funnel Key 1 dome NOTE For dimensions of parameters, see Table 1. Figure 1 Form B: stem, cut ampoule with constriction Figure 2 Form C: stem, open-funnel ampoule with constriction Figure 3 Form D: stem, sealed ampoule with constriction DIN EN ISO 9187-1:2011-01

39、EN ISO 9187-1:2010 (E) 7 Table 1 Dimensions of ampoules Dimensions in millimetres Nominal volume ml Dimension 1 2 3 5 10 20 25 30 10,75 10,75 12,75 14,75 17,75 22,5 22,5 22,5 Body d1atol. 0,15 0,15 0,15 0,15 0,20 0,25 0,25 0,25 6,5 6,5 6,5 7 7,5 8,5 8,5 8,5 Constriction d2btol. 0,5 0,5 0,5 0,5 0,5 0

40、,5 0,5 0,5 8,5 8,5 8,5 9 9,5 12 12 12 Bulb d3tol. 0,5 0,5 0,5 0,5 0,5 1 1 1 6 6 6 7 7,1 7,8 7,8 7,8 Stem d4tol. 0,35 0,35 0,35 0,35 0,35 0,5 0,5 0,5 9 9 10,7 12,2 13 14 14 14 Funnel d5ctol. 0,8 0,8 0,8 1 1 1 1 1 10 10 10,5 12 13,5 13,5 13,5 13,5 Dome d6ctol. 1 1 1 1 1 1 1 1 8 8 8 9 9,5 11 11 11 Exte

41、rnal diameter Flared end d7tol. 1 1 1 1 1 1 1 1 60 72 75 83 102 113 128 143 Form B h1tol. 1 1 1 1 1 1 1 1 67 79 82 90 109 120 135 150 Form C h2tol. 1 1 1 1 1 1,5 1,5 1,5 70 83 89 95 112 126 141 156 Overall height Form D h3tol. 1 1 1 1 1 1 1 1 25,5 37,5 39,5 46,5 62 76 91 106 Height to constriction h

42、4tol. 0,5 0,5 0,5 0,5 1 1,3 1,3 1,3 47 57 62 68 87 100 115 130 Height to gauging point h5tol. 2 2 2 2 2 2 2 2 Body height h6min. 21 33 35 41 55 65 80 95 Height Height measured from centre of constriction to bulb h7max. 4,5 4,5 5 5,5 6 6,5 6,5 6,5 1 1 1,5 1,5 1,5 2,0 2,0 2,0 Radius r tol. 0,5 0,5 0,5

43、 0,5 0,5 0,5 0,5 0,5 1 1 1 1 1,25 1,5 1,5 1,5 Base Depth of the base e tol. 0,5 0,5 0,5 0,5 0,75 1 1 1 DIN EN ISO 9187-1:2011-01 EN ISO 9187-1:2010 (E) 8 Table 1 (continued) Dimensions in millimetres Nominal volume ml Dimension 1 2 3 5 10 20 25 30 0,5 0,5 0,5 0,55 0,6 0,7 0,7 0,7 Glass thickness of

44、body w1tol. 0,03 0,03 0,03 0,03 0,04 0,04 0,04 0,04 0,37 0,37 0,37 0,40 0,47 0,50 0,50 0,50 Glass thickness of stem at gauging w2tol. 0,05 0,05 0,05 0,05 0,05 0,05 0,05 0,05 Glass thickness at base w3min. 0,3 0,3 0,3 0,4 0,4 0,5 0,5 0,5 0,7 0,7 0,7 0,7 0,8 1 1 1 Glass thickness at constrictionw4tol.

45、 0,1 0,1 0,1 0,15 0,15 0,2 0,2 0,2 Glass thickness of dome w50,1 to 0,25 0,1 to 0,30 Circular run-out tolerance td0,6 0,6 0,8 1 1 1,2 1,2 1,2 Wall thickness Volume to centre of constrictionV ml 1,5 2,3 3,5 5,5 11,5 23,5 28,5 33,5 aThe deviation from the perpendicularity between bottom and length axi

46、s at the body outside diameter shall not exceed an angle of 2.bIf there is a need to reduce the constriction diameter, e.g. due to a reduction of particles, it shall be agreed between themanufacturer and purchaser.cNo point of the funnel and the dome shall be outside the body diameter.dThe run-out t

47、olerance shall be measured at the sealing point (according to ISO 1101). Table 2 Breaking force Breaking force Nominal volume ml Length l (= l1+ l2) mm Fmin.N Fmax.N 1 2 3 5 36 (= 18 + 18) 80 10 90 20 25 30 60 (= 22 + 38) 30 100 DIN EN ISO 9187-1:2011-01 EN ISO 9187-1:2010 (E) 9 6 Test for breaking

48、force 6.1 Principle The test is suitable for determining the force required to separate the ampoule stem from the body and for assessing whether a clean break is obtained. 6.2 Tensile testing machine The tensile testing machine shall be in accordance with ISO 7500-1 and have the following characteri

49、stics: a test speed, v, of 10 mm/min; a measuring range for force of 200 N. NOTE Other test procedures, e.g. with a power increase of 20 N/s, are admissible if equivalent results can be obtained. An example of the test set-up is illustrated in Figure 4. 6.3 Sampling 6.3.1 Number of samples Random sampling in accordance with ISO 2859-1 (inspection level S-4)