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
6、y contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed bu t shall not be edited unless the typefaces which are embedded are licensed t o and installed on the computer performing the editin g. In downloading this file, parties accept therein the r
7、esponsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details oft he software produc tsu sed to create thisP DF file can be found in the General In f o relative to the file;t he PDF-
8、cr eation parameters were optimized for printing. Every care has been taken to ensure that thef ile is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it isf ound, please inform the Central Secretariat at the address given below . COPYRIGHT PROTECTED DOCUMENT
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
36、dards-related publications, information and services. It presents the UK view on standards in Europe and at the international level. BSI is incorporated by Royal Charter. British Standards and other standardisation products are published by BSI Standards Limited. British Standards Institution (BSI)
37、raising standards worldwide BSI 389 Chiswick High Road London W4 4AL UK Te l + 4 4 ( 0 ) 2 0 8 9 9 6 9 0 0 1 Fax +44 (0)20 8996 7001 Revisions British Standards and PASs are periodically updated by amendment or revision. Users of British Standards and PASs should make sure that they possess the lat
38、est amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using British Standards would inform the Secretary of the technical committee responsible, the identity of which can
39、be found on the inside front cover. S i m i l a r y f o r P A S s , p l e a s e n o t i f y B S I C u s t o m e r S e r v i c e s . Te l : + 4 4 ( 0 ) 2 0 8 9 9 6 9 0 0 1 F a x : + 4 4 ( 0 ) 2 0 8 9 9 6 7 0 0 1 BSI offers BSI Subscribing Members an individual updating service called PLUS which ensur
40、es that subscribers automatically receive the latest editions of British Standards and PASs. Te l : + 4 4 ( 0 ) 2 0 8 9 9 6 7 6 6 9 F a x : + 4 4 ( 0 ) 2 0 8 9 9 6 7 0 0 1 Email: Buying standards Yo u m a y b u y P D F a n d h a rd c o p y v e r s i o n s o f s t a n d a rd s d i re c t l y u s i n
41、 g a credit card from the BSI Shop on the website In addition all orders for BSI, international and foreign standards publications can be addressed to BSI Customer Services. Te l : + 4 4 ( 0 ) 2 0 8 9 9 6 9 0 0 1 F a x : + 4 4 ( 0 ) 2 0 8 9 9 6 7 0 0 1 Email: In response to orders for internationa
42、l standards, BSI will supply the British Standard implementation of the relevant international standard, unless otherwise requested. Information on standards BSI provides a wide range of information on national, European and international standards through its Knowledge Centre. Te l : + 4 4 ( 0 ) 2
43、0 8 9 9 6 7 0 0 4 F a x : + 4 4 ( 0 ) 2 0 8 9 9 6 7 0 0 5 Email: BSI Subscribing Members are kept up to date with standards developments and receive substantial discounts on the purchase price of standards. For details of these and other benefits contact Membership Administration. Te l : + 4 4 ( 0
44、) 2 0 8 9 9 6 7 0 0 2 F a x : + 4 4 ( 0 ) 2 0 8 9 9 6 7 0 0 1 Email: Information regarding online access to British Standards and PASs via British Standards Online can be found at Further information about British Standards is available on the BSI website at www.bsi- Copyright All the data, softwa
45、re and documentation set out in all British Standards and other BSI publications are the property of and copyrighted by BSI, or some person or entity that own copyright in the information used (such as the international standardisation bodies) has formally licensed such information to BSI for commer
46、ical publication and use. Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does
47、not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations. If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained. Details and advice can be obtained from the Copyright & Licensing Department. Te l : + 4 4 ( 0 ) 2 0 8 9 9 6 7 0 7 0 Email:
