EN ISO 9187-2-2010 en Injection equipment for medical use - Part 2 One-point-cut (OPC) ampoules《医用注射器具 色点刻(OPC)安瓿》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 9187-2:2010Injection equipment formedical usePart 2: One-point-cut (OPC) ampoulesBS EN ISO 9187-2:2010 BRITISH STANDARDNational forewordThis British Standard is the UK

2、implementation of EN ISO9187-2:2010. It supersedes BS EN ISO 9187-2:1999 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 n

3、ot purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 70348 5ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the

4、Standards Policy and Strategy Committee on 30 November 2010.Amendments issued since publicationDate Text affectedEUROPEAN 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-p

5、oint-cut (OPC) ampoules (ISO 9187-2:2010) Matriel dinjection usage mdical - Partie 2: Ampoules un seul point de cassure (OPC) (ISO 9187-2:2010) Injektionsgerte zur medizininischen Verwendung - Teil 2: OPC-Ampullen (ISO 9187-2:2010) This European Standard was approved by CEN on 13 October 2010. CEN m

6、embers 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 applic

7、ation 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 ha

8、s 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, P

9、oland, 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 and b

10、y any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9187-2:2010: EBS EN ISO 9187-2:2010EN ISO 9187-2:2010 (E) 3 Foreword The text of ISO 9187-2:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical u

11、se” 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 standard, either by publica

12、tion 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 shall

13、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: Austria, Belgium, Bulg

14、aria, 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 notice

15、 The text of ISO 9187-2:2010 has been approved by CEN as a EN ISO 9187-2:2010 without any modification. This page deliberately left blankBS EN ISO 9187-2:2010ISO 9187-2:2010(E) ISO 2010 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation

16、 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 which a technical committee has been established has the right to be represented on that committee.

17、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 matters of electrotechnical standardization. International Standards are drafted in accordance wit

18、h 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 circulated to the member bodies for voting. Publication as an International Standard requires approv

19、al 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 responsible for identifying any or all such patent rights. ISO 9187-2 was prepared by Technical Committ

20、ee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 9187-2:1993), which has undergone a minor revision with the following modifications: the reference to ISO 9187-1 has been updated; the diame

21、ter of the point has been designated d8(instead of d7) to be in line with the designation in ISO 9187-1. 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 9187-2:2010I

22、SO 9187-2:2010(E) iv ISO 2010 All rights reservedIntroduction Ampoules are suitable packaging materials 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 in

23、teractions are to be avoided in order to guarantee patient safety. Adequate means to achieve this 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 system

24、s. BS EN ISO 9187-2:2010INTERNATIONAL STANDARD ISO 9187-2:2010(E) ISO 2010 All rights reserved 1Injection equipment for medical use Part 2: One-point-cut (OPC) ampoules 1 Scope This part of ISO 9187 specifies materials, dimensions and requirements for forms of one-point-cut (OPC) ampoules (forms B,

25、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 references, th

26、e 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 in Table 1

27、 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 B OPC ampo

28、ule 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. BS EN ISO 9187-2:2010ISO 9187-2:2010(E) 2 ISO 2010 All rights rese

29、rvedTable 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 Requir

30、ements 5.1 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 s

31、hall comply 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 pigmen

32、ts, shall be fixed in the centre above the cut. The maximum deviation from the centerline shall not exceed 1 mm. BS EN ISO 9187-2:2010ISO 9187-2:2010(E) ISO 2010 All rights reserved 3Table 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 +

33、 18) 70 10 20 25 30 60 (= 22 + 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

34、of 120 C, followed by dipping 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 BS EN ISO 9187-2:2010ISO 9187-2:2010(E) 4 ISO 2010 All rights reserved6 Delivery Delivery conditions

35、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. BS EN ISO 9187-2:2010This page deliberately left blankBSI is the independent national body resp

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