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1、BRITISH STANDARD BS EN ISO 8536-1:2008 Infusion equipment for medical use Part 1: Infusion glass bottles 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 21:42:59 MDTNo reproduc
2、tion or networking permitted without license from IHS -,-,- BS EN ISO 8536-1:2008 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 59470 0 National foreword This British Standard is the UK implementation o
3、f EN ISO 8536-1:2008. It is identical to ISO 8536-1:2006. It supersedes BS EN ISO 8536-1:2003 which is withdrawn.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 secreta
4、ry. 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 Brit
5、ish Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction or networking permitted without license from IHS -,-,- EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-1 March 2008
6、ICS 11.040.20Supersedes EN ISO 8536-1:2003 English Version Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2006) Matriel de perfusion usage mdical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2006) Infusionsgerte zur medizinischen Verwendung - Teil 1: Infus
7、ionsflaschen aus Glas (ISO 8536-1:2006) 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 alteration. Up-
8、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 translation un
9、der 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, Germany, Greece
10、, 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 NORMUNG Management
11、 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 8536-1:2008: E Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing
12、Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction or networking permitted without license from IHS -,-,- Foreword The text of ISO 8536-1:2006 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” of th
13、e International Organization for Standardization (ISO) and has been taken over as EN ISO 8536-1:2008 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 publication of an
14、 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 CENELEC shall no
15、t be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-1:2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgar
16、ia, 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 The text o
17、f ISO 8536-1:2006 has been approved by CEN as a EN ISO 8536-1:2008 without any modification. BS EN ISO 8536-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction o
18、r 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 technical committe
19、es. 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 with the Inte
20、rnational 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 International S
21、tandards 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 may be the su
22、bject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8536-1 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 second edit
23、ion (ISO 8536-1:2000) and amendment ISO 8536-1:2000/Amd.1:2004, of which it constitutes a minor revision. ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use: Part 1: Infusion glass bottles Part 2: Closures for infusion bottles Part 3: Aluminium caps
24、for infusion bottles Part 4: Infusion sets for single use, gravity feed Part 5: Burette infusion sets for single use, gravity feed Part 6: Freeze drying closures for infusion bottles Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 8: Infusion equipment for use with pre
25、ssure infusion apparatus Part 9: Fluid lines for use with pressure infusion equipment Part 10: Accessories for fluid lines for use with pressure infusion equipment Part 11: Infusion filters for use with pressure infusion equipment Part 12: Check valves BS EN ISO 8536-1:2008 Copyright British Standar
26、ds Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction or networking permitted without license from IHS -,-,- iv Introduction Infusion bottles are suitable primary packaging materials for the stor
27、age of infusion solutions until they are administered to the patient. Due to the direct contact between infusion solution and the primary container components and in view of the extended storage periods, possible interactions must be avoided in order to guarantee the patients safety. Adequate means
28、to achieve this goal include the proper selection of the primary packaging materials, the choice of suitable package design and the availability of specific criteria and methods for testing of individual container systems. BS EN ISO 8536-1:2008 Copyright British Standards Institution Provided by IHS
29、 under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction or networking permitted without license from IHS -,-,- 1 Infusion equipment for medical use Part 1: Infusion glass bottles 1 Scope This part of ISO 8536 specifies the dime
30、nsions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refe
31、rences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 719:1985, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification ISO 720:1985, Glass Hydrolytic resistance of glass gra
32、ins at 121 C Method of test and classification ISO 1101:2004, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out ISO 4802-1:1988, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by
33、titration method and classification ISO 4802-2:1988, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7458:2004, Glass containers Internal pressure resistance Test methods ISO 7459:2004, Glass containers T
34、hermal shock resistance and thermal shock endurance Test methods 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 4802-1 and ISO 4802-2 apply. BS EN ISO 8536-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncon
35、trolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 4 Dimensions The dimensions of the infusion glass bottles shall meet the requirements of Figure 1 and Tables 1, 2 and 3. Dimensions in millimetre
36、s Figure 1 Infusion glass bottle, showing three typical neck finishes BS EN ISO 8536-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction or networking permitted
37、without license from IHS -,-,- 3 Dimensions in millimetres a) Model A: Infusion bottle with 32 mm neck finish b) Model B: Infusion bottle with 28 mm neck finish c) Model C: Infusion bottle with 29 mm neck finish NOTE The marks (optional) or other markings in accordance with the view from below may b
38、e placed on the bottom or at the bottom radius, r2, of the infusion bottle. The drawing represents a typical example. Key 1 ISO symbol 2 bottom surface 3 designation of hydrolytic resistance container class (see 9.1) 4 manufacturers code/designation of mould 5 manufacturers trade mark 6 graduation m
39、ark a Bottom surface may be granular. Figure 1 (continued) BS EN ISO 8536-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction or networking permitted without lic
40、ense from IHS -,-,- 4 Table 1 Dimensions and capacity of infusion glass bottles with 32 mm neck finish (model A) Dimensions in millimetres Nominal capacity Approximate brimful capacity t a d1 d2 h1 h2 h3 r1 r2 r3 r4 ml ml tol. tol. tol. 50 68 5 1 46 0,8 37 68 0,7 58 36,5 2 12 20,5 8 100 128 5 1,3 49
41、 0,8 39 104 0,8 94 68,5 3 12 25 8 125 147 5 1,3 54,4 0,8 38,9 98 0,8 88 63 4,5 20 17 12 250 297 8 1,6 68 1 48,9 125 1 114,578 7 32 28 12 500 584 8 1,9 86 1,2 61,5 147 1 137 93,4 8 32 27 12 1 000 1120 15 3 95 1,5 69,6 225 1,3 215 148 8,5 55 52 22 a The tolerance t of the perpendicularity (as defined
42、in ISO 1101) is a limit for the deviation of the plumb-line through the centre of the bottom part and the axis of the bottle at the upper edge of the flange. Table 2 Dimensions and capacity of infusion glass bottles with 28 mm neck finish (model B) Dimensions in millimetres Nominal capacity Approxim
43、ate brimful capacity t a d1 d2 h1 h2 h3 r1 r2 r3 r4 ml ml tol. tol. tol. 50 68 5 1 46 0,8 37 68,7 0,7 60,5 37 2 12 20 8 100 128 5 1,3 49 0,8 39 104,7 0,8 96,5 69 3 12 25 8 125 147 5 1,3 54,4 0,8 38,9 98,7 0,8 90,5 62,5 4,5 20 17 8 250 300 8 1,6 68 1 48,9 125 1 117,578 7 32 28 12 500 584 8 1,9 86 1,2
44、 61,5 147,7 1 139,593,4 8 32 27 13 1 000 1120 15 3 95 1,5 69,6 225 1,3 216,8148 8,5 55 52 15 a The tolerance t of the perpendicularity (as defined in ISO 1101) is a limit for the deviation of the plumb-line through the centre of the bottom part and the axis of the bottle at the upper edge of the fla
45、nge. Table 3 Dimensions and capacity of infusion glass bottles with 29 mm neck finish (model C) Dimensions in millimetres Nominal capacity Approximate brimful capacity t a d1 d2 h1 h2 h3 r1 r2 r3 r4 ml ml tol. tol. tol. 50 68 5 1 46 0,8 37 68 0,7 60,4 37,5 2 12 20,5 8 100 128 5 1,3 49 0,8 39 104 0,8
46、 96,4 68,5 3 12 25 8 125 147 5 1,3 54,4 0,8 38,9 98,7 0,8 91,1 63,7 4,5 20 17 10 250 300 8 1,6 68 1 48,9 125 1 117,478 7 32 28 10 500 572 8 1,9 86 1,2 61,5 147 1 139,493,4 8 32 27 12 1 000 1120 15 3 95 1,5 69,6 224,1 1,3 216,8147,48,5 55 52 15 a The tolerance t of the perpendicularity (as defined in
47、 ISO 1101) is a limit for the deviation of the plumb-line through the centre of the bottom part and the axis of the bottle at the upper edge of the flange. BS EN ISO 8536-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:42:59 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 5 Designation 5.1 General An infusion glass bottl