1、December 2011 Translation by DIN-Sprachendienst.English price group 10No 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).I
2、CS 11.040.20!$xU-“1855010www.din.deDDIN EN ISO 8536-1Infusion equipment for medical use Part 1: Infusion glass bottles (ISO 8536-1:2011)English translation of DIN EN ISO 8536-1:2011-12Infusionsgerte zur medizinischen Verwendung Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2011)Englische bersetzung
3、 von DIN EN ISO 8536-1:2011-12Matriel de perfusion usage mdical Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2011)Traduction anglaise de DIN EN ISO 8536-1:2011-12SupersedesDIN EN ISO 8536-1:2008-06www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be co
4、nsidered authoritative.1511.11 DIN EN ISO 8536-1:2011-12 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). The res
5、ponsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-03 AA Verpackungssysteme fr die Befllung und Applikation von medizinischen Produkten. DIN EN ISO 8536 consists of the following parts, under the general title I
6、nfusion equipment for medical use: Part 1: Infusion glass bottles Part 2: Closures for infusion bottles Part 3: Aluminium caps for infusion bottles Part 4: Infusion sets for single use, gravity feed Part 5: Burette infusion sets for single use, gravity feed1) Part 8: Infusion equipment for use with
7、pressure 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 DIN ISO 8536 consists of the following parts, under the general ti
8、tle Infusion equipment for medical use: Part 6: Freeze drying closures for infusion bottles Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 12: Check valves The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO
9、719 DIN ISO 719 ISO 720 DIN ISO 720 ISO 1101 DIN EN ISO 1101 ISO 4802-1 DIN ISO 4802-1 ISO 4802-2 DIN ISO 4802-2 ISO 7458 DIN EN ISO 7458 ISO 7459 DIN EN ISO 7459 1) Under revision. DIN EN ISO 8536-1:2011-12 3 Amendments This standard differs from DIN EN ISO 8536-1:2008-06 as follows: a) normative r
10、eferences to ISO 4802-1 and ISO 4802-2 have been updated; b) a NOTE has been included in Clause 8: “Other test methods may be required by national or regional regulations”. Previous editions DIN 58363: 1960-07 DIN 58363-1: 1974-01, 1984-03 DIN 58363-5: 1974-01, 1983-11 DIN 58375-1: 1966-03 DIN ISO 8
11、536-1: 1992-04, 2001-01 DIN EN ISO 8536-1: 2004-05, 2008-06 National Annex NA (informative) Bibliography DIN EN ISO 1101, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out DIN EN ISO 7458, Glass containers Internal pressure resista
12、nce Test methods DIN EN ISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methods DIN ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification DIN ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and
13、 classification DIN ISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification DIN ISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectr
14、ometry and classification DIN EN ISO 8536-1:2011-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-1 September 2011 ICS 11.040.20 Supersedes EN ISO 8536-1:2008English Version Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 85
15、36-1:2011) Matriel de perfusion usage mdical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2011) Infusionsgerte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2011) This European Standard was approved by CEN on 31 August 2011. CEN members are bound to comply
16、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-CENELEC Ma
17、nagement 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-CENELEC Management Centre has the same
18、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, Poland, Port
19、ugal, 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 2011 CEN All rights of exploitation in any form and by any means
20、 reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-1:2011: EContents DIN EN ISO 8536-1:2011-12 EN ISO 8536-1:2011 (E) 2 Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Dimensions.6 5 Designation 9 5.1 General9 5.2 Location of designation
21、 marks.9 6 Material .9 7 Performance .9 8 Requirements.9 8.1 Hydrolytic resistance 10 8.2 Internal pressure resistance.10 8.3 Thermal shock resistance.10 8.4 Annealing quality.10 9 Marking .10 Bibliography 11 Foreword This document (EN ISO 8536-1:2011) has been prepared by Technical Committee ISO/TC
22、 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use . This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2012, and conflicting national st
23、andards shall be withdrawn at the latest by March 2012. 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 not be held responsible for identifying any or all such patent rights. This document supersedes EN IS
24、O 8536-1:2008. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, I
25、celand, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8536-1:2011 has been approved by CEN as a EN ISO 8536-1:2011 without any modificatio
26、n. “” DIN EN ISO 8536-1:2011-12 EN ISO 8536-1:2011 (E) 3 Introduction Infusion bottles are suitable primary packaging materials for the storage of infusion solutions until they are administered to the patient. Due to the direct contact between infusion solution and the primary container components a
27、nd in view of the extended storage periods, it is essential to avoid possible interactions in order to guarantee the patients safety. Adequate means to achieve this goal include the proper selection of the primary packaging materials, the choice of suitable package design and the availability of spe
28、cific criteria and methods for testing of individual container systems. DIN EN ISO 8536-1:2011-12 EN ISO 8536-1:2011 (E) 4 1 Scope This part of ISO 8536 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicabl
29、e only to infusion bottles for single use. 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 (including any amen
30、dments) 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 grains at 121 C Method of test and classification ISO 4802-1:2010, Glassware Hydrolytic resistance of the interior surfaces of glass
31、 containers Part 1: Determination by titration method and classification ISO 4802-2:2010, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7458, Glass containers Internal pressure resistance Test methods I
32、SO 7459, Glass containers Thermal 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. DIN EN ISO 8536-1:2011-12 EN ISO 8536-1:2011 (E) 5 4 Dimensions The dimensions of
33、 the infusion glass bottle shall meet the requirements of Figure 1 and Tables 1, 2 and 3. Dimensions in millimetres a) General description Figure 1 Infusion glass bottle, showing three typical neck finishes (continued) DIN EN ISO 8536-1:2011-12 EN ISO 8536-1:2011 (E) 6 Dimensions in millimetres b) M
34、odel A: Infusion bottle with 32 mm neck finish c) Model B: Infusion bottle with 28 mm neck finish d) Model C: Infusion bottle with 29 mm neck finish Key 1 ISO logo (optional) 2 bottom surface 3 designation of hydrolytic resistance container class (see 9.1) 4 manufacturers code/designation of mould 5
35、 manufacturers trade mark 6 graduation mark NOTE The marks (optional) or other markings in accordance with the view from below can be placed on the bottom or at the bottom radius, r2, of the infusion bottle. The drawing represents a typical example. aBottom surface may be granular. Figure 1 Infusion
36、 glass bottle, showing three typical neck finishes DIN EN ISO 8536-1:2011-12 EN ISO 8536-1:2011 (E) 7 Table 1 Dimensions and capacity of infusion glass bottles with 32 mm neck finish (model A) Dimensions in millimetres Nominal capacity Approximate brimful capacity aad1d2h1h2h3r1r2r3r4ml ml tol. tol.
37、 tol. 50 100 125 250 500 1 000 68 128 147 297 584 1 120 5 5 5 8 8 15 1 1,3 1,3 1,6 1,9 3 46 49 54,4 68 86 95 0,8 0,8 0,8 1 1,2 1,5 37 39 38,9 48,9 61,5 69,6 68 104 98 125 147 225 0,7 0,8 0,8 1 1 1,3 58 94 88 114,5137 215 36,5 68,5 63 78 93,4 148 2 3 4,5 7 8 8,5 12 12 20 32 32 55 20,525 17 28 27 52 8
38、 8 12 12 12 22 aThe tolerance a of the perpendicularity (defined as 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 f
39、inish (model B) Dimensions in millimetres Nominal capacity Approximate brimful capacity aad1d2h1h2h3r1r2r3r4ml ml tol. tol. tol. 50 100 125 250 500 1 000 68 128 147 300 584 1 120 5 5 5 8 8 15 1 1,3 1,3 1,6 1,9 3 46 49 54,4 68 86 95 0,8 0,8 0,8 1 1,2 1,5 37 39 38,9 48,9 61,5 69,6 68,7 104,798,7 125 1
40、47,7225 0,7 0,8 0,8 1 1 1,3 60,5 96,5 90,5 117,5139,5216,837 69 62,5 78 93,4 148 2 3 4,5 7 8 8,5 12 12 20 32 32 55 20 25 17 28 27 52 8 8 8 12 13 15 aThe tolerance a of the perpendicularity (defined as in ISO 1101) is a limit for the deviation of the plumb-line through the centre of the bottom part a
41、nd the axis of the bottle at the upper edge of the flange.Table 3 Dimensions and capacity of infusion glass bottles with 29 mm neck finish (model C) Dimensions in millimetres Nominal capacity Approximate brimful capacity aad1d2h1h2h3r1r2r3r4ml ml tol. tol. tol. 50 100 125 250 500 1 000 68 128 147 30
42、0 572 1 120 5 5 5 8 8 15 1 1,3 1,3 1,6 1,9 3 46 49 54,4 68 86 95 0,8 0,8 0,8 1 1,2 1,5 37 39 38,9 48,9 61,5 69,6 68 104 98,7 125 147 224,10,7 0,8 0,8 1 1 1,3 60,4 96,4 91,1 117,4139,4216,837,5 68,5 63,7 78 93,4 147,42 3 4,5 7 8 8,5 12 12 20 32 32 55 20,525 17 28 27 52 8 8 10 10 12 15 aThe tolerance
43、a of the perpendicularity (defined as 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.DIN EN ISO 8536-1:2011-12 EN ISO 8536-1:2011 (E) 8 5 Designation 5.1 General An infusion glass bottle for
44、 medical use complying with the requirements laid down in this part of ISO 8536 is designated using the descriptor “Infusion bottle” followed by, in the order given, a reference to this part of ISO 8536, the model of the infusion bottle, the nominal capacity, the colour and the hydrolytic resistance
45、 container class (see 8.1). EXAMPLE 1 An infusion bottle (model A) with a nominal capacity of 500 ml, made of colourless glass (cl) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows: Infusion bottle ISO 8536-1 A
46、500 cl HC 2 EXAMPLE 2 An infusion bottle (model C) with a nominal capacity of 500 ml, made of colourless glass (cl) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows: Infusion bottle ISO 8536-1 C 500 cl HC 2 5.2
47、Location of designation marks The designation marks on the bottom, as specified in Figure 1 a), may also be fixed at the body of the bottle but not at the cylindrical part. The manufacturers code can also be placed at the shoulder of the bottle. If marked at the lower bottom radius, r2, or at the sh
48、oulder, r3, the diameter at these places should not exceed the diameter, d1, of the bottle. The designation of hydrolytic resistance container class is abbreviated as given in 9.1. 6 Material Infusion bottles shall be constructed from a) colourless (cl) or amber (br) borosilicate glass (see ISO 4802
49、-1:2010, 3.6, and ISO 4802-2:2010, 3.6), or b) soda-lime-silica glass (see ISO 4802-1:2010, 3.7, and ISO 4802-2:2010, 3.7) of the following hydrolytic resistance grain class: ISO 720 HGA 1; ISO 719 HGB 3 or ISO 720 HGA 2. A change in the composition of the glass material or of the colouring oxides shall be notified to the user at least nine months in advance. 7 Performance
