EN ISO 9187-1-2010 en Injection equipment for medical use - Part 1 Ampoules for injectables《医用注射设备 注射针药瓶》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 9187-1:2010Injection equipment formedical usePart 1: Ampoules for injectablesBS EN ISO 9187-1:2010 BRITISH STANDARDNational forewordThis British Standard is the UK impl

2、ementation of EN ISO9187-1:2010. It supersedes BS EN ISO 9187-1:2008 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not p

3、urport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 70347 8ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStan

4、dards Policy and Strategy Committee on 30 November 2010.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM 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

5、for injectables (ISO 9187-1:2010) Matriel dinjection usage mdical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010) Injektionsgerte zur medizinischen Verwendung - Teil 1: Ampullen fr Injektionsprparate (ISO 9187-1:2010) This European Standard was approved by CEN on 13 October 2010. CE

6、N 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 lists and bibliographical references concerning such national standards may be obtained on app

7、lication to the CEN 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 Management Centre

8、 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway

9、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form an

10、d by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9187-1:2010: EBS EN ISO 9187-1:2010EN ISO 9187-1:2010 (E) 3 Foreword The text of ISO 9187-1:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutica

11、l 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 Standard shall be given the status of a national standard, either by publ

12、ication 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 this document may be the subject of patent rights. CEN and/or CENELEC sha

13、ll 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 countries are bound to implement this European Standard: Austria, Belgium, B

14、ulgaria, Croatia, Cyprus, Czech Republic, 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 the United Kingdom. Endorsement not

15、ice The text of ISO 9187-1:2010 has been approved by CEN as a EN ISO 9187-1:2010 without any modification. BS EN ISO 9187-1:2010ISO 9187-1:2010(E) ISO 2010 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

16、(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 which a technical committee has been established has the right to be represented on that committee. International organizations, g

17、overnmental and non-governmental, in liaison 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/I

18、EC Directives, Part 2. The main task of technical 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 mem

19、ber 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 responsible for identifying any or all such patent rights. ISO 9187-1 was prepared by Technical Committee ISO/TC 76, Transfusion, inf

20、usion and injection equipment for medical and pharmaceutical use. This fourth edition cancels and replaces the third edition (ISO 9187-1:2006), which has undergone a minor revision with the following modifications in Table 1. The base radius, r, has been modified for the 10 ml, 20 ml, 25 ml and 30 m

21、l glass. ISO 9187 consists 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 BS EN ISO 9187-1:2010ISO 9187-1:2010(E) iv ISO 2010 All rights reservedIntroduction Ampoules are suitable packaging ma

22、terials for storing pharmaceutical 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 thi

23、s objective include proper 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

24、 use. However, form A is 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 u

25、se and to disregard the letter A. BS EN ISO 9187-1:2010INTERNATIONAL STANDARD ISO 9187-1:2010(E) ISO 2010 All rights reserved 1Injection equipment for medical use Part 1: Ampoules for injectables 1 Scope This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging req

26、uirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with 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

27、 manufacturer and user. Ampoules complying with this part of ISO 9187 are intended for single use only. 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

28、latest edition of the referenced document (including any amendments) applies. ISO 720, Glass Hydrolytic resistance of glass grains at 121 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

29、) for lot-by-lot inspection ISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame sp

30、ectrometry and classification 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 3 Dimensions and designation 3.1 Dimensions The dimensions of ampoules shall be as sh

31、own in Figures 1, 2 and 3 (forms B, C and D respectively) and as given in Table 1. BS EN ISO 9187-1:2010ISO 9187-1:2010(E) 2 ISO 2010 All rights reserved3.2 Designation Designation of ampoules shall consist of the descriptor word “ampoule”, followed by a reference to this part of ISO 9187, followed

32、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 ampoule 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 9

33、187: 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 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) gla

34、ss 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 be notified by the ampoule manufacturer to the user at least nine months in advance. 5 Requirements 5.1 Hydrolytic resistance When tested in acc

35、ordance with ISO 4802-1 and ISO 4802-2, the hydrolytic resistance of the internal surface of ampoules shall comply with the requirements specified for hydrolytic resistance container class HCT1 and HCF1 respectively 5.2 Annealing quality Ampoules shall be annealed; the maximum residual stress of unc

36、oloured ampoules after annealing shall not produce an optical retardation exceeding 50 nm/mm of glass thickness. 5.3 Breaking force The breaking test shall be carried out on ampoules with a predetermined breaking point, such as a ceramic ring, at the constriction. When tested in accordance with Clau

37、se 6, the breaking force shall be as specified in Table 2. BS EN ISO 9187-1:2010ISO 9187-1:2010(E) ISO 2010 All rights reserved 3Key 1 constriction 2 sealing point 3 stem 4 bulb 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,

38、 cut ampoule with constriction Figure 2 Form C: stem, open-funnel ampoule with constriction Figure 3 Form D: stem, sealed ampoule with constriction BS EN ISO 9187-1:2010ISO 9187-1:2010(E) 4 ISO 2010 All rights reservedTable 1 Dimensions of ampoules Dimensions in millimetres Nominal volume ml Dimensi

39、on 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 0,5 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 d4

40、tol. 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 External 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 6

41、7 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 h4tol. 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

42、 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 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 BS E

43、N ISO 9187-1:2010ISO 9187-1:2010(E) ISO 2010 All rights reserved 5Table 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 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

44、,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. 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 Cir

45、cular 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 axis at the body outside diameter shall not exceed an angle of 2.bIf there is a need to red

46、uce 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 tolerance shall be measured at the sealing point (according to ISO 1101). Table 2 Breakin

47、g 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 BS EN ISO 9187-1:2010ISO 9187-1:2010(E) 6 ISO 2010 All rights reserved6 Test for breaking force 6.1 Principle The test is suitable for determining the force re

48、quired 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 characteristics: a test speed, v, of 10 mm/min; a measuring range for force of

49、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) is recommended. 6.3.2 Conditioning of samples The temperature