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1、INTERNATIONAL STANDARD ISO 9187-2 First edition 1993-06-15 Injection equipment for medical use - Part 2: One-Point-tut (OPC) ampoules Ma Wie/ dinjection 3 usage medical - Partie 2: Ampoules In un seul Point de cassure (OPC) Reference number - ISO 91872: 1993(E) Copyright International Organization f
2、or Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:05:49 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187=2:1993(E) Contents Page 1 Scope . . . . . . . . . . . . . . . . . . . . . .
3、. . . . . . . . . . . . . . . . . . . . . 1 2 Normative reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3 Dimensions and designation . 1 4 Material 1 5 Requirements 2 6 Delivery . . . . . . . .
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5、. . . . . . . . . . . . . . . . . 3 8 Marking .,.,.,.,.,., 3 0 ISO 1993 All rights reserved. No part of this publication may be reproduced or utilized in any form or by any means, electronie or mechanical, including photocopying and microfilm, without per- mission in writing from the publisher. Inte
6、rnational Organization for Standardization Case Postale 56 l CH-l 211 Geneve 20 l Switzerland Printed in Switzerland ii Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:05:49 M
7、DTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187=2:1993(E) 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
8、out through ISO technical committees. Esch 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
9、collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approv
10、al by at least 75 % of the member bodies casting a vote. International Standard ISO 9187-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical use. ISO 9187 consists of the following Parts, under the general title Injection equipment for medical u
11、se: - Part 1: Ampoules for injectables - Part 2: One-Point-Cut (OPC) ampoules Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:05:49 MDTNo reproduction or networking permitted
12、without license from IHS -,-,- ISO 9187=2:1993(E) Introduction Ampoules are suitable primary packaging materials for storing pharma- ceutical products until they are administered to the Patient. Owing to the direct contact between injectables and the primary Container over ex- tended storage periods
13、, possible interactions must be avoided in Order to guarantee Patient safety. Adequate means to achieve this objective in- clude proper selection of primary packaging materials, the choice of suit- able package design and the availability of specific requirements and methods for testing individual C
14、ontainer Systems. iv Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:05:49 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO
15、 9187=2:1993(E) Injection equipment for medical use - Part 2: One-Point-tut (OPC) ampoules 1 Scope This part of ISO 9187 specifies materials, dimensions and requirements for forms of one-Point-Cut (OPC) ampoules (forms B, C and D) for injectables. Ampoules complying with this part of ISO 9187 are in
16、tended for Single use only. 2 Normative reference The following Standard contains provisions which, through reference in this text, constitute provisions of this part of ISO 9187. At the time of publication, the edition indicated was valid. All Standards are subject to revision, and Parties to agree
17、ments based on this part of ISO 9187 are encouraged to investigate the possibility of applying the most recent edition of the Standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 9187-1: 1991, Injection equipment for medical use - Part 1
18、: Ampoules for injectables. 3 Dimensions and designation 3.1 Dimensions The dimensions for OPC ampoules shall be as laid down in ISO 9187-1 and as given in table 1. See figure 1 for typical examples. 3.2 Designation Designation example of a form B OPC ampoule with a nominal volume of 10 ml, made of
19、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 9187-1:1991, clause 4. Table 1 - Dimensions of OPC ampoules Dimensions in millimetres Nom- Distance from inal Diameter bottom
20、 line to Wall vol- of Point upper line of thickness at Point constriction um8 ml d7 43 S4 max. 1 32,5 2 44,5 0,7 * 0,lO 3 46,5 5 54,0 0,7 f 0,15 / 2 f 015 IO 70,o 0,8 f 0,15 20 84,5 25 99,5 1 * 0,20 30 114,5 Copyright International Organization for Standardization Provided by IHS under license with
21、ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:05:49 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187=2:1993(E) FormB FormC FormD Figure 1 - Typical examples of OPC ampoules 5 Requirements 5.1 Hydrolytic resistance The hydrolytic re
22、sistance shall be in accordance with ISO 9187-1:1991, subclause 5.1. 5.2 Annealing quality The annealing quality shall be in accordance with ISO 9187-1: 1991, subclause 5.2. 5.3 Breaking forte When tested in accordance with ISO 9187-1:1991, clause 6, the breaking forte shall comply with the values l
23、aid down in table2. In special cases it may be possible to agree to a breaking forte with a lower tolerante. This tolerante shall be agreed between manufacturer and User. 5.4 Position and stability of Point 54.1 The Point consisting of colour Pigments shall be fixed in the centre above the Cut. The
24、maximum deviation from the centreline shall not exceed * 1 mm. Table 2 - Breaking forte Nominal volume Length (2 = 2, + Z*) Breaking forte l 1136 118 118 111 10to30 1 60 1 22 1 38 1 30 1 80 1 When testing the breaking forte, the equipment shall be positioned on the centre of the tut, as otherwise a
25、considerable increase of breaking forte would re- sult. 5.4.2 The Point shall withstand 30 min heating in a drying oven at a temperature of 120 “C followed by dipping into water at 30 “C. 5.4.3 The Point shall withstand the usual cleaning and sterilization conditions. 2 Copyright International Organ
26、ization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:05:49 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187=2:1993(E) 6 Delivery 8 Marking Delivery conditions shall be in acco
27、rdance with ISO 9187-1 :1991, clause 7. Marking shall be in accordance with ISO 9187-1 :1991, clause 9. 7 Packaging Packaging shall be in accordance with ISO 9187-1 :1991, clause 8. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technica
28、l Standards 1/9972545001 Not for Resale, 04/26/2007 03:05:49 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187=2:1993(E) UDC 615.456.014.83 Descriptors: medical equipment, parenteral infusion equipment, ampoules, glass, specifications, dimensions, tests, designation, marking, packaging. Price based on 3 pages Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/26/2007 03:05:49 MDTNo reproduction or networking permitted without license from IHS -,-,-