BS ISO 8536-7-2013 Infusion equipment for medical use Caps made of aluminium-plastics combinations for infusion bottles《医用输液器具 输液瓶用铝和塑料复合物制帽盖》.pdf

1、raising standards worldwide NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BSI Standards Publication BS ISO 8536-7:2009 Infusion equipment for medical use Part 7: Caps made of aluminium-plastics combinations for infusion bottles BS ISO 8536-7:2009 BRITISH STANDARD National fo

2、reword This British Standard is the UK implementation of ISO 8536-7:2009. 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 secretary. This publication does not purport to

3、 include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013 ISBN 978 0 580 82567 5 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal obligation

4、s. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2013. Amendments issued since publication Date Text affectedBS ISO 8536-7:2009 Reference number ISO 8536-7:2009(E) ISO 2009 INTERNATIONAL STANDARD ISO 8536-7 Th i r d e d i ti o n 20

5、09-01-15 Infusion equipment for medical use Part 7: Caps made of aluminium-plastics combinations for infusion bottles Matriel de perfusion usage mdical Partie 7: Capsules en combinaison aluminium-plastique pour flacons de perfusionBS ISO 8536-7:2009 ISO 8536-7:2009(E) PDF disclaimer ThisP DF file ma

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9、ISO 2009 All rights reserved. Unless otherwises pecified, no part of this publicationm ay be reproduced or utilized in any form or by any means, electronic or mechanical, i ncluding p hotocopying and microfilm, w ithout p ermission in w riting from e ither ISO at t he address b e low or ISOs member

10、body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published inS witzerland ii ISO 2009 All rights reservedBS ISO 8536-7:2009 ISO 8536-7:2009(E) ISO 2009 All rights reserved

11、 iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO m ember b odies). T he work o f preparing I nternational Standards is n ormally carried o ut t hrough I SO technical committees. Each member bodyi nterested in a subject

12、 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 I SO, also t ake part in the work. ISO c ollaborates closelyw ith the International Electrotechnical Com mission (I

13、EC) 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 t echnical committees i s to prepare International S tandards. Draft Internationa l Standards adopted by t he technical

14、c ommittees a re c irculated t o the member b odies f or v oting. P ublication 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 subject of patent rights. IS

15、O shall not be held responsible for identifying an y or all such patent rights. ISO 8536-7 wasp repared byT echnical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and phamaceutical use . This t hird edition cancels and replaces t he second edition (ISO 8536-7:1999),

16、Clause 2 of w hich h as been updated. 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 f

17、eed 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 pressure infusion apparatus Part 9: Fluid lines for use with pressure i

18、nfusion 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 valvesBS ISO 8536-7:2009 ISO 8536-7:2009(E) iv ISO 2009 All rights reserved Introduction The materials from which infusion

19、 glass bottles (including elastomeric closures) are made are suitable primary packaging materials f or s toring i nfusion solutions u ntil they are administered. H owever, in t his part of ISO 8536, c aps of a luminium-plastics combinations are not considered as p rimary p ackaging materials in dire

20、ct contact with the infusion solution. BS ISO 8536-7:2009 INTERNATIONAL STANDARD ISO 8536-7:2009(E) ISO 2009 All rights reserved 1 Infusion equipment for medical use Part 7: Caps made of aluminium-plastics combinations for infusion bottles 1 Scope This part of ISO 8536 specifies caps made of alumini

21、um-plastics combinations intended for use on 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 references, only the edition cited applies. For undated references,

22、 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 individu- al tolerance indications ISO 2768-2, General tolerances Part 2: Geometrical tolerances for features without individ

23、ual tolerance indications ISO 8536-1, Infusion equipment for medical use Part 1: Infusion glass bottles ISO 8536-3, Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles ISO 8872:2003, Aluminium caps for transfusion, infusion and injection bottles General requirements and te

24、st methods ISO 10985, Caps made of aluminium-plastics combinations for infusion bottles and injection vials Requirements and test methods 3 Classification of type Caps shall be classified as follows: Type ZB: aluminium cap with central opening and plastics component; Type ZD: aluminium cap with comp

25、lete tear-off tab and plastics component. BS ISO 8536-7:2009 ISO 8536-7:2009(E) 2 ISO 2009 All rights reserved 4 Dimensions and tolerances 4.1 Dimensions All cover versions (flat, ring-s haped or others) of caps shall meet the dimensions given in Figure 1 and Table 1. NOTE The shape of the cap shown

26、 in Figure 1 is an example only. 4.2 Tolerances Cap tolerances shall be ina ccor dance with ISO 2768-1 and ISO 2768-2. Dimensions in millimetres a) Type ZB b) Type ZD Key 1 plasticsc omponent 2 aluminium cap 3 score line Figure 1 Configuration of cap Table 1 Dimensions of cap Dimensions in millimetr

27、es d 1 d 2 a d 3 b e c h 1 h 2 d Nominal size 0,1 0,05 + min. max.m in. max.m in. max . 0,25 min. max . 28 28,1 30,5 31,5 12 17 0,168 0,242 8,6 to 9,0 9 12 32 32,6 3 5,5 37 15 20 11,9 13 16 aT he diameter, d 2 ,s hall be agreed upon between the manufacturer and the user. It shall not differ from the

28、 nominal value by more than 0,25 mm. The extreme limits are given without tolerance. b After plastics element removal. c T he thickness, e , shall be agreed upon between the manufacturer and the user. It shall not differ from the nominal value by more than 0,022 mm. The extreme limits are given with

29、out tolerance. dT he height , h 2 ,s hall be agreed upon between them anufacturer and the user. It shall not differ from the nominal value by more than 0,4 mm. The extreme limits are given without tolerance.BS ISO 8536-7:2009 ISO 8536-7:2009(E) ISO 2009 All rights reserved 3 5 Designation Aluminium-

30、plastics caps shall be designated according to type. The designation is e xpressed as t he word “ C ap”, f ollowed b y the number a nd part of t his I nternational Standard, followed by the type letters, followed by the nominal size of the cap. EXAMPLE A type ZD a luminium-plastics cap o f nominal s

31、ize3 2 complying with the requirements of this part of ISO 8536 is designated as follows: Cap ISO 8536-7 - ZD - 32 6 Requirements 6.1 General requirements 6.1.1 The requirements for aluminium caps shall be in accordance with ISO 8536-3. 6.1.2 The requirements for plastics components and for the comb

32、ination between the plastics component and the aluminium cap shall be in accordance with ISO 10985. 6.1.3 Constructione lements which penetratei ntot he interior space of the aluminium cap shall not interfere with the sealing process. 6.2F orce required to remove tab 6.2.1 The maximumf orce required

33、 to remove the tab shall comply with Table 2. Table 2 Force required to remove plastics component and tear-off tab completely Force in newtons Nominal size Force to remove plastics component max . Force to tear off tab completely max . 28 32 40 60 30 40 6.2.2 For incoming control, a minimum value fo

34、r the tear-off tab removal force shall bea greed between the supplier and the user. The infusion caps shall alsow ithstand a sterilization process in accordance with 5.1 of ISO 8872:2003. 7 Packaging Packaging shall comply with the requirements of ISO 8872. 8 Marking Marking shall be in accordance w

35、ith ISO 8872 and the designation shall be as specified in Clause 5. BS ISO 8536-7:2009 ISO 8536-7:2009(E) ICS 11.040.20 Price based on 3 pages ISO 2009 All rights reserved This page deliberately left blankBSI is the independent national body responsible for preparing British Standards and other stan

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