《BS-EN-ISO-9187-1-2008.pdf》由会员分享，可在线阅读，更多相关《BS-EN-ISO-9187-1-2008.pdf（14页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 9187-1:2008 Injection equipment for medical use Part 1: Ampoules for injectables ICS 11.040.20 ? Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:43:16 MDTNo repro
2、duction or networking permitted without license from IHS -,-,- BS EN ISO 9187-1:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2008 BSI 2008 ISBN 978 0 580 56641 7 National foreword This British Standard is the UK implementatio
3、n of EN ISO 9187-1:2008. It is identical to ISO 9187-1:2006. It supersedes BS EN ISO 9187-1:2003 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs. A list of organizations represented on this committee can be obtained on request to its secr
4、etary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments Copyright B
5、ritish Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:43:16 MDTNo reproduction or networking permitted without license from IHS -,-,- EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9187-1 March 20
6、08 ICS 11.040.20Supersedes EN ISO 9187-1:2003 English Version Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2006) Matriel dinjection usage mdical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2006) Injektionsgerte zur medizinischen Verwendung - Teil
7、1: Ampullen fr Injektionsprparate (ISO 9187-1:2006) This European Standard was approved by CEN on 7 March 2008. 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 national standard without any alt
8、eration. 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 in any other language made by tr
9、anslation 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Ger
10、many, 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 NORMALISATION EUROPISCHES KOMITEE FR NORMUN
11、G Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9187-1:2008: E Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Lice
12、nsee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:43:16 MDTNo reproduction or networking permitted without license from IHS -,-,- Foreword The text of ISO 9187-1:2006 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutica
13、l use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 9187-1:2008 by Technical Committee CEN/SS S02 “Transfusion equipment” the secretariat of which is held by CMC. This European Standard shall be given the status of a national standard, either by publi
14、cation of an identical text or by endorsement, at the latest by September 2008, and conflicting national standards shall be withdrawn at the latest by September 2008. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENE
15、LEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9187-1:2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Bel
16、gium, Bulgaria, 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 notic
17、e The text of ISO 9187-1:2006 has been approved by CEN as a EN ISO 9187-1:2008 without any modification. BS EN ISO 9187-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:43:16 MDTNo re
18、production or networking permitted without license from IHS -,-,- iii Foreword 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 techni
19、cal 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely w
20、ith the International Electrotechnical Commission (IEC) on all matters 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 Int
21、ernational 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 member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document m
22、ay 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, infusion and injection equipment for medical and pharmaceutical use. This third edition cancels and replaces the
23、 second edition (ISO 9187-1:2000), which has undergone a minor revision with the addition of footnote a) in Table 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 This corre
24、cted version of ISO 9187-1:2006 incorporates the correction of Table 1 on page 4. BS EN ISO 9187-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:43:16 MDTNo reproduction or networkin
25、g permitted without license from IHS -,-,- iv Introduction 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 inter
26、actions are 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 systems. In the
27、 past, four standardized forms of ampoule (forms A, B, C and D) have been in widespread 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 retai
28、n the same designation letters (i.e. B, C and D) for the forms of ampoules in current use, and to disregard the letter A. BS EN ISO 9187-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008
29、21:43:16 MDTNo reproduction or networking permitted without license from IHS -,-,- 1 Injection equipment for medical use Part 1: Ampoules for injectables 1 Scope This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule
30、 (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 manufacturer and user. Ampoules complying
31、 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 latest edition of the referenced document
32、(including any amendments) applies. ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO 1101, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out ISO 2859-1, Sampling procedures for ins
33、pection 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: Determination by titration method and classification ISO 4802-2, Glassware Hydrolytic re
34、sistance 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/compression testing machines Verification and calibration of the force-measuring system
35、 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. BS EN ISO 9187-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=B
36、oeing Co/5910770001 Not for Resale, 08/14/2008 21:43:16 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 3.2 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,
37、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 9187: Ampoule ISO 9187
38、-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) glass of hydrolytic resi
39、stance grain class ISO 720 HGA 1 shall be used. A change in the chemical composition of the glass material should be notified by the tube 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 h
40、ydrolytic resistance of the internal surface of ampoules shall comply with the requirements specified for hydrolytic resistance container class ISO 4802- HC 1. 5.2 Annealing quality Ampoules shall be annealed; the maximum residual stress of uncoloured ampoules after annealing shall not produce an op
41、tical retardation exceeding 50 nm per millimetre of glass thickness. 5.3 Breaking force It is presumed that the ampoules to be tested are provided 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
42、 specified in Table 2. BS EN ISO 9187-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:43:16 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 Key 1 constric
43、tion 2 sealing point 3 stem 4 bulb 5 shoulder 6 base or bottom Key 1 funnel Key 1 dome NOTE For other dimensions, see Figure 1. NOTE For other dimensions, see Figure 1. NOTE For dimensions of parameters, see Table 1. Figure 1 Form B: stem, cut ampoule with constriction Figure 2 Form C: stem, open-fu
44、nnel ampoule with constriction Figure 3 Form D: stem, sealed ampoule with constriction BS EN ISO 9187-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:43:16 MDTNo reproduction or netw
45、orking permitted without license from IHS -,-,- 4 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 d1 a tol. 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 d2
46、 b tol. 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 d3 tol. 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 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 d5 c tol. 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 d6 c tol. 1 1 1
47、1 1 1 1 1 8 8 8 9 9,5 11 11 11 External diameter Flared end d7 tol. 1 1 1 1 1 1 1 1 60 72 75 83 102 113 128 143 Form B h1 tol. 1 1 1 1 1 1 1 1 67 79 82 90 109 120 135 150 Form C h2 tol. 1 1 1 1 1 1,5 1,5 1,5 70 83 89 95 112 126 141 156 Overall height Form D h3 tol. 1 1 1 1 1 1 1 1 25,5 37,5 39,5 46,5 62 76 91 106 Height to constriction h4 tol. 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 h5 tol. 2 2 2 2 2 2 2 2 Bo