1、BS EN ISO8536-3:2009ICS 11.040.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDInfusion equipment formedical usePart 3: Aluminium caps for infusionbottles (ISO 8536-3:2009)This British Standard was published under the authority of the Standards Policy and Stra
2、tegy Committee on 30 June 2009. BSI 2009ISBN 978 0 580 66658 2Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 8536-3:2009National forewordT h i s B r i t i s h S t a n d a r d i s t h e U K i m p l e m e n t a t i o n o f E N I S O 8 5 3 6 - 3 : 2 0 0 9 . I t i s i d e n t i c a
3、 l t o I S O 8 5 3 6 - 3 : 2 0 0 9 . I t s u p e r s e d e s B S E N I S O 8 5 3 6 - 3 : 1 9 9 9 w h i c h i s withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained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 s
4、ecretary.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.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 8536-3June 2009IC
5、S 11.040.20 Supersedes EN ISO 8536-3:1999 English VersionInfusion equipment for medical use - Part 3: Aluminium caps forinfusion bottles (ISO 8536-3:2009)Matriel de perfusion usage mdical - Partie 3: Capsulesen aluminium pour flacons de perfusion (ISO 8536-3:2009)Infusionsgerte zur medizinischen Ver
6、wendung - 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 EuropeanStandard the status of a national st
7、andard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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
8、 language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Fin
9、land,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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMIT
10、EE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 8536-3:2009: EBS EN ISO 8536-3:2009EN ISO 8536-3:2009 (E) 3 Foreword This document (EN ISO 8536-3:2009) has be
11、en prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“ in collaboration with CEN Sub-sector S02 “Transfusion equipment”, the secretariat of which is held by CMC. This European Standard shall be given the status of a national st
12、andard, either by publication of an identical text or by endorsement, at the latest by December 2009, and conflicting national 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 ri
13、ghts. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes 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 S
14、tandard: Austria, Belgium, 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 Kingd
15、om. Endorsement notice The text of ISO 8536-3:2009 has been approved by CEN as a EN ISO 8536-3:2009 without any modification. BS EN ISO 8536-3:2009ISO 8536-3:2009(E) ISO 2009 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of nationa
16、l standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical 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. Internation
17、al organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules
18、 given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at le
19、ast 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 subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8536-3 was prepared by Technical Committee ISO/TC 7
20、6, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This third edition cancels and replaces the second edition (ISO 8536-3:1999), which has been updated in Clause 2 (Normative references). In addition, the height and the tolerances of aluminium caps have been aligned
21、 with those given in ISO 8536-7. 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 for infusion bottles Part 4: Infusion sets for single use, gravity feed P
22、art 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 pressure infusion apparatus Part 9: Fluid lines for use with pressure infusi
23、on 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 8536-3:2009ISO 8536-3:2009(E) iv ISO 2009 All rights reservedIntroduction The materials from which infusion gl
24、ass 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.
25、BS EN ISO 8536-3:2009INTERNATIONAL STANDARD ISO 8536-3:2009(E) ISO 2009 All rights reserved 1Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles 1 Scope This part of ISO 8536 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1. 2 Nor
26、mative 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 amendments) applies. ISO 2768-1, General tolerances
27、Part 1: Tolerances for linear and angular dimensions without individual tolerance indications ISO 2768-2, General tolerances 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, Al
28、uminium caps for transfusion, infusion and injection bottles General requirements and test methods 3 Dimensions and tolerances 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 compone
29、nts of a two-piece tear-off cap are: an aluminium cap with centre hole, type A; a protective aluminium cap with complete tear-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 t
30、ear-off tab, type F. NOTE The width and the number of bridges for types C and F are a function of the intended resistance. BS EN ISO 8536-3:2009ISO 8536-3:2009(E) 2 ISO 2009 All rights reserved3.2 Tolerances The tolerances shall be in accordance with ISO 2768-1 and ISO 2768-2. 4 Designation Caps sha
31、ll 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 ISO 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 no
32、minal 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 General 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 c
33、aps 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 tab 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 remov
34、e 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 cap 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
35、The packaging of aluminium caps shall comply with the requirements of ISO 8872. 7 Marking The aluminium caps shall be marked in accordance with ISO 8872 and with the designation as defined in Clause 4. BS EN ISO 8536-3:2009ISO 8536-3:2009(E) ISO 2009 All rights reserved 3Table 1 Dimension of alumini
36、um 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 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 th
37、e 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 millimetres a) Type A Aluminium cap with centre hole b) Type C Aluminium cap with three-bridge tab Figure 1 One-piece tear-off cap BS EN ISO 8536-
38、3:2009ISO 8536-3:2009(E) 4 ISO 2009 All rights reservedDimensions 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 2 Two-piece tear-off cap BS EN ISO 8536-3:2009ISO 8536-3:2009(E) ISO 2009 All righ
39、ts reserved 5Dimensions 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 cap Table 2 Minimum and maximum forces to remove the complete tear-off tab (type F) or three-bridge t
40、ab (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. BS EN ISO8536-3:2009BSI Grou
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