DIN EN ISO 9187-2-2011 Injection equipment for medical use - Part 2 One-point-cut (OPC) ampoules (ISO 9187-2 2010) German version EN ISO 9187-2-2010《医用注射设备 第2部分 色点刻(OPC)安瓿(ISO 9187.pdf

1、January 2011 Translation by DIN-Sprachendienst.English price group 8No 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

2、 11.040.20!$m,L“1740941www.din.deDDIN EN ISO 9187-2Injection equipment for medical use Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)English translation of DIN EN ISO 9187-2:2011-01Injektionsgerte zur medizinischen Verwendung Teil 2: OPC-Ampullen (ISO 9187-2:2010)Englische bersetzung von DIN

3、 EN ISO 9187-2:2011-01Matriel dinjection usage mdical Partie 2: Ampoules un seul point de cassure (OPC) (ISO 9187-2:2010)Traduction anglaise de DIN EN ISO 9187-2:2011-01SupersedesDIN ISO 9187-2:1994-01www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be conside

4、red authoritative.100 .11 2DIN EN ISO 9187-2:2011-01 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) in collabora

5、tion 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 consists of the f

6、ollowing parts, under the general title Injection equipment for medical use: Part 1: Ampoules for injectables Part 2: One-point-cut (OPC) ampoules The DIN Standard corresponding to the International Standard referred to in this document is as follows: ISO 9187-1 DIN EN ISO 9187-1 Amendments This sta

7、ndard differs from DIN EN ISO 9187-2:1994-01 as follows: a) the diameter of the point has been designated d8(instead of d7) to be in line with the designation in ISO 9187-1; b) the standard has been editorially revised. Previous editions DIN EN ISO 9187-2: 1994- National Annex NA (informative) Bibli

8、ography DIN EN ISO 9187-1, Injection equipment for medical use Part 1: Ampoules for injectables p01EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9187-2 October 2010 ICS 11.040.20 Supersedes EN ISO 9187-2:1999English Version Injection equipment for medical use - Part 2: One-point-cut (OPC)

9、 ampoules (ISO 9187-2:2010) Matriel dinjection usage mdical - Partie 2: Ampoules un seul point de cassure (OPC) (ISO 9187-2:2010) Injektionsgerte zur medizinischen Verwendung - Teil 2: OPC-Ampullen (ISO 9187-2:2010) This European Standard was approved by CEN on 13 October 2010. CEN members are bound

10、 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 CEN

11、 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 has the same statu

12、s 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, Poland, Portugal,

13、 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 and by any means rese

14、rved worldwide for CEN national Members. Ref. No. EN ISO 9187-2:2010: EContents DIN EN ISO 9187-2:2011-01 EN ISO 9187-2:2010 (E) 2 PageForeword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Dimensions and designation5 3.1 Dimensions.5 3.2 Designation 5 4 Material .5 5 Requirements.6 5.1 Hydr

15、olytic resistance 6 5.2 Annealing quality.6 5.3 Breaking force6 5.4 Position and stability of breaking point 6 6 Delivery .8 7 Packaging .8 8 Marking .8 Foreword The text of ISO 9187-2:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical

16、and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 9187-2:2010 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 standar

17、d, 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 this document may be the subject of patent rights. CEN a

18、nd/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9187-2:1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Au

19、stria, 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, Slovenia, Spain, Sweden, Switzerland and the United Kingdom

20、. Endorsement notice The text of ISO 9187-2:2010 has been approved by CEN as a EN ISO 9187-2:2010 without any modification. DIN EN ISO 9187-2:2011-01 EN ISO 9187-2:2010 (E) 3 Introduction Ampoules are suitable packaging materials for storing pharmaceutical products until they are administered to the

21、 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 proper selection of primary packaging materials, the choic

22、e of suitable package design and the availability of specific requirements and methods for testing individual container systems. DIN EN ISO 9187-2:2011-01 EN ISO 9187-2:2010 (E) 4 1 Scope This part of ISO 9187 specifies materials, dimensions and requirements for forms of one-point-cut (OPC) ampoules

23、 (forms B, C and D) for injectables. 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 ref

24、erences, the latest edition of the referenced document (including any amendments) applies. ISO 9187-1:2010, Injection equipment for medical use Part 1: Ampoules for injectables 3 Dimensions and designation 3.1 Dimensions The dimensions of OPC ampoules shall be as specified in ISO 9187-1 and as given

25、 in Table 1 and Figure 1 of this part of ISO 9187. 3.2 Designation Designation of OPC 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 and the colour of the glass. EXAMPLE Designation of a form

26、 B OPC ampoule with a nominal volume of 10 ml, made of colourless glass (cl) complying with the requirements of this part of ISO 9187: Ampoule ISO 9187-2 OPC B 10 cl 4 Material The material shall be in accordance with ISO 9187-1:2010, Clause 4. DIN EN ISO 9187-2:2011-01 EN ISO 9187-2:2010 (E) 5 Tabl

27、e 1 Dimensions of OPC ampoules Dimensions in millimetresNominal volume ml Diameter of point d8Distance from bottom line to upper line of point h9max. Wall thickness at constriction w4 1 32,5 2 44,5 3 46,5 0,7 0,1 5 54,0 0,7 0,15 10 70,0 0,8 0,15 20 84,5 25 99,5 30 2 0,5 114,5 1 0,20 5 Requirements 5

28、.1 Hydrolytic resistance The hydrolytic resistance shall be in accordance with ISO 9187-1:2010, 5.1. 5.2 Annealing quality The annealing quality shall be in accordance with ISO 9187-1:2010, 5.2. 5.3 Breaking force When tested in accordance with ISO 9187-1:2010, Clause 6, the breaking force shall com

29、ply with the values specified in Table 2. In special cases, it may be possible to agree to a breaking force with a lower tolerance. This tolerance shall be agreed between manufacturer and user. 5.4 Position and stability of breaking point 5.4.1 The breaking point, consisting of colour pigments, shal

30、l be fixed in the centre above the cut. The maximum deviation from the centerline shall not exceed 1 mm. DIN EN ISO 9187-2:2011-01 EN ISO 9187-2:2010 (E) 6 Table 2 Breaking force Breaking force Nominal volume ml Length l (= l1+ l2) mm Fmin.N Fmax.N 1 2 3 25 65 5 36 (= 18 + 18) 70 10 20 25 30 60 (= 2

31、2 + 38) 30 80 When testing the breaking force, the equipment shall be positioned on the centre of the cut otherwise a considerable increase in breaking force will result. 5.4.2 The breaking point shall withstand a heating period of 30 min in a drying oven at a temperature of 120 C, followed by dippi

32、ng into water at 30 C. 5.4.3 The breaking point shall withstand usual cleaning and sterilization conditions. Form B Form C Form D Figure 1 Typical examples of OPC ampoules DIN EN ISO 9187-2:2011-01 EN ISO 9187-2:2010 (E) 7 6 Delivery Delivery conditions shall be in accordance with ISO 9187-1:2010, Clause 7. 7 Packaging Packaging shall be in accordance with ISO 9187-1:2010, Clause 8. 8 Marking Marking shall be in accordance with ISO 9187-1:2010, Clause 9. DIN EN ISO 9187-2:2011-01 EN ISO 9187-2:2010 (E) 8