1、September 2009DEUTSCHE NORM English price group 9No part of this standard 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).ICS 11.040.20!$Ya“1546229
2、www.din.deDDIN EN ISO 8536-3Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009)English version of DIN EN ISO 8536-3:2009-09Infusionsgerte zur medizinischen Verwendung Teil 3: Aluminium-Brdelkappen fr Infusionsflaschen (ISO 8536-3:2009)Englische Fassung DI
3、N EN ISO 8536-3:2009-09SupersedesDIN ISO 8536-3:2001-07www.beuth.deDocument comprises 13 pagesDIN EN ISO 8536-3:2009-09 2 National foreword This standard has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” in collabora
4、tion with Technical Committee CEN Sub-sector S02 “Transfusion equipment” (Secretariat: CMC). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-02-09 AA Sekundrpackmittel und Zubehr. ISO 8536 consists of t
5、he 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 for infusion bottles Part 4: Infusion sets for single use, gravity feed Part 5: Burette infusion sets for single use, gravity fe
6、ed 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 pressure infusion apparatus Part 9: Fluid lines for use with pressure infusion equipment Part 10: Accessories for fluid lines for u
7、se with pressure infusion equipment Part 11: Infusion filters for use with pressure infusion equipment Part 12: Check valves The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 2768-1 DIN ISO 2768-1 ISO 2768-2 DIN ISO 2768-2 ISO 8536-1 DIN
8、EN ISO 8536-1 ISO 8872 DIN EN ISO 8872 Amendments This standard differs from DIN ISO 8536-3:2001-07 as follows: a) Clause 2 “Normative references” has been updated. b) DIN ISO 8536-7. Previous editions DIN 58363: 1960-07 DIN 58363-3: 1975-05, 1979-09 DIN 58375-1: 1966-03 DIN 58375-2: 1966-03 DIN ISO
9、 8536-3: 1993-02, 2001-07 In Table 1, dimension h and the tolerances for aluminium caps have been aligned with those given in DIN EN ISO 8536-3:2009-09 3 National Annex NA (informative) Bibliography DIN ISO 2768-1, General tolerances Tolerances for linear and angular dimensions without individual to
10、lerance indications DIN ISO 2768-2, General tolerances Geometrical tolerances for features without individual tolerances indications DIN EN ISO 8536-1, Infusion equipment for medical use Part 1: Infusion glass bottles DIN EN ISO 8536-2, Infusion equipment for medical use Part 2: Closures for infusio
11、n bottles DIN EN ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed DIN ISO 8536-5, Infusion equipment for medical use Part 5: Burette infusion sets for single use, gravity fed DIN ISO 8536-6, Infusion equipment for medical use Part 6: Freeze drying clo
12、sures for infusion bottles DIN ISO 8536-7, Infusion equipment for medical use Part 7: Caps made of aluminium-plastics combinations for infusion bottles DIN EN ISO 8536-8, Infusion equipment for medical use Part 8: Infusion equipment for use with pressure infusion apparatus DIN EN ISO 8536-9, Infusio
13、n equipment for medical use Part 9: Fluid lines for use with pressure infusion equipment DIN EN ISO 8536-10, Infusion equipment for medical use Part 10: Accessories for fluid lines for use with pressure infusion equipment DIN EN ISO 8536-11, Infusion equipment for medical use Part 11: Infusion filte
14、rs for use with pressure infusion equipment DIN EN ISO 8872, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods DIN EN ISO 8536-3:2009-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-3 June 2009 ICS
15、 11.040.20 Supersedes EN ISO 8536-3:1999 English Version Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009) Matriel de perfusion usage mdical - Partie 3: Capsules en aluminium pour flacons de perfusion (ISO 8536-3:2009)Infusionsgerte zur medizinischen
16、Verwendung - Teil 3: Aluminium-Brdelkappen fr Infusionsflaschen (ISO 8536-3:2009) This European Standard was approved by CEN on 16 May 2009. 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 nati
17、onal standard without any alteration. 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
18、any other language made by translation 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,
19、Estonia, Finland, France, Germany, 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
20、EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-3:2009: EContents Page Foreword .3 1 Scope5 2 Normative references5 3 Dimensions and
21、tolerances5 3.1 Dimensions 5 3.2 Tolerances6 4 Designation 6 5 Requirements.6 5.1 General requirements .6 5.2 Force required to remove tab.6 5.2.1 Three-bridge tab (type C)6 5.2.2 Complete tear-off tab (type F) 6 5.2.3 Three-piece tear-off cap6 6 Packaging.6 7 Marking.6 2 DIN EN ISO 8536-3:2009-09 E
22、N ISO 8536-3:2009 (E) Foreword Sub-sector 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 identical text or by endorsement, at the latest by December 2009, and conflicting natio
23、nal standards shall be withdrawn at the latest by December 2009. 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 superse
24、des EN ISO 8536-3:1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, 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 8536-3:2009 has been approved by CEN as a EN ISO 8536-3:2009 without any modificatio
26、n. 3 EN ISO 8536-3:2009 (E) DIN EN ISO 8536-3:2009-09 This document (EN ISO 8536-3:2009) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” in collaboration with CEN Introduction The materials from which infusion glas
27、s bottles (including elastomeric closures) are made are suitable primary packaging materials for storing infusion solutions until they are administered. However, in this part of ISO 8536, aluminium caps are not considered as primary packaging material in direct contact with the infusion solution. 4
28、DIN EN ISO 8536-3:2009-09 EN ISO 8536-3:2009 (E) 1 Scope This part of ISO 8536 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refe
29、rences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 2768-1, General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications ISO 2768-2, General tolerance
30、s Part 2: Geometrical tolerances for features without individual tolerance indications ISO 8536-1, Infusion equipment for medical use Part 1: Infusion glass bottles ISO 8872, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods 3 Dimensions and toleran
31、ces 3.1 Dimensions The dimensions of the caps shall be as shown in Figures 1 to 3 and as given in Table 1. The shapes of the caps are shown only as typical examples. The components of a two-piece tear-off cap are: an aluminium cap with centre hole, type A; a protective aluminium cap with complete te
32、ar-off tab, type F. The components of a three-piece tear-off cap are: an aluminium cap with centre hole, type A; a protective disc, E; a protective aluminium cap with complete tear-off tab, type F. NOTE The width and the number of bridges for types C and F are a function of the intended resistance.
33、5 EN ISO 8536-3:2009 (E) DIN EN ISO 8536-3:2009-09 3.2 Tolerances The tolerances shall be in accordance with ISO 2768-1 and ISO 2768-2. 4 Designation Caps shall be designated as one-, two- or three-piece, and according to type. The designation is expressed as the word “cap”, the number and part of I
34、SO 8536 followed by the type letter plus the number of pieces if more than one and the nominal size of the cap. EXAMPLE A type A two-piece aluminium cap of nominal size 32 complying with the requirements of this part of ISO 8536 is designated as follows: Cap ISO 8536-3 - A2 - 32 5 Requirements 5.1 G
35、eneral requirements 5.1.1 Under normal conditions of use and handling, assembled caps shall be considered as a whole until the crimping operation. 5.1.2 The caps shall meet the requirements of ISO 8872. 5.2 Force required to remove tab 5.2.1 Three-bridge tab (type C) The force needed to remove the t
36、ab shall be determined as specified in ISO 8872 and shall be within the range given in Table 2. 5.2.2 Complete tear-off tab (type F) The force needed to remove the tab completely shall be determined as specified in ISO 8872 and shall be within the range given in Table 2. 5.2.3 Three-piece tear-off c
37、ap The minimum force required to push the cap with centre hole (type A) into the protective cap with complete tear-off tab (type F) shall be 5 N. 6 Packaging The packaging of aluminium caps shall comply with the requirements of ISO 8872. 7 Marking The aluminium caps shall be marked in accordance wit
38、h ISO 8872 and with the designation as defined in Clause 4. 6 DIN EN ISO 8536-3:2009-09 EN ISO 8536-3:2009 (E) Table 1 Dimension of aluminium caps Dimensions in millimetres d1d2d4h ear Nominal size Type 0,10,05+ 0,2 min. 0,25 0,2 A, C 28,1 12 to 21 8,6 to 9,0 1 Disc E 27,3 28 F 15 to 21 1 A, C 32,6
39、15 to 21 11,9 1 Disc E 30 32 F 15 to 21 0,168 e 0,242 1 aThe thickness shall be agreed upon between the manufacturer and the user within the given range. The thickness shall not differ from the nominal value by more than 0,022 mm. The extreme limits are given without tolerance. Dimensions in millime
40、tres a) Type A Aluminium cap with centre hole b) Type C Aluminium cap with three-bridge tab Figure 1 One-piece tear-off cap 7 EN ISO 8536-3:2009 (E) DIN EN ISO 8536-3:2009-09 Dimensions in millimetres a) Type A Aluminium cap with centre hole b) Type F Protective aluminium cap with complete tear-off
41、tab Key 1 tear-off perforation Figure 2 Two-piece tear-off cap 8 DIN EN ISO 8536-3:2009-09 EN ISO 8536-3:2009 (E) Dimensions in millimetres a) Type A Aluminium cap with centre hole b) Type F Protective aluminium cap with complete tear-off tab Key 1 tear-off perforation Figure 3 Three-piece tear-off
42、cap Table 2 Minimum and maximum forces to remove the complete tear-off tab (type F) or three-bridge tab (type C) Force to break bridges N Force to tear off tab completely N Nominal size min. max. min. max. 28 10 40 5 25 32 30 60 20 40 NOTE In the case of multiple bridges, the resistance against pressure shall be sufficient, but the breaking force is reduced accordingly. 9 EN ISO 8536-3:2009 (E) DIN EN ISO 8536-3:2009-09
