BS ISO 15375-2010 Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods《医用输液瓶 多用途悬吊装置 试验方法和要求》.pdf

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1、BS ISO15375:2010ICS 11.040.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDMedical infusionbottles Suspensiondevices for multipleuse Requirementsand test methodsThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee

2、on 30 June2010 BSI 2010ISBN 978 0 580 66148 8Amendments/corrigenda issued since publicationDate CommentsBS ISO 15375:2010National forewordThis British Standard is the UK implementation of ISO 15375:2010. Itsupersedes BS ISO 15375:2004 which is withdrawn.The UK participation in its preparation was en

3、trusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a Brit

4、ish Standard cannot confer immunityfrom legal obligations.BS ISO 15375:2010Reference numberISO 15375:2010(E)ISO 2010INTERNATIONAL STANDARD ISO15375Second edition2010-06-15Medical infusion bottles Suspension devices for multiple use Requirements and test methods Flacons mdicaux de transfusion et de p

5、erfusion Dispositifs de suspension usage multiple Exigences et mthodes dessai BS ISO 15375:2010ISO 15375:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces wh

6、ich are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems I

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8、 that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mecha

9、nical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member 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

10、.org Published in Switzerland ii ISO 2010 All rights reservedBS ISO 15375:2010ISO 15375:2010(E) ISO 2010 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internat

11、ional 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. International organizations, governmental and non-governmental, in liaison with I

12、SO, 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 given in the ISO/IEC Directives, Part 2. The main task of technical c

13、ommittees 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 least 75 % of the member bodies casting a vote. Attention is drawn to th

14、e 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 15375 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharma

15、ceutical use. This second edition cancels and replaces the first edition (ISO 15375:2004), Clause 2 of which has been technically revised. BS ISO 15375:2010ISO 15375:2010(E) iv ISO 2010 All rights reservedIntroduction This International Standard deals with permanent suspension devices for multiple u

16、se for infusion bottles in accordance with ISO 8536-1. The intended purpose of suspension devices is to avoid dropdowns of infusion bottles during administering of blood or pharmaceutical solutions. BS ISO 15375:2010INTERNATIONAL STANDARD ISO 15375:2010(E) ISO 2010 All rights reserved 1Medical infus

17、ion bottles Suspension devices for multiple use Requirements and test methods 1 Scope This International Standard specifies requirements for permanent suspension devices, fixed to infusion racks or set-up devices, for infusion bottles that confirm to the requirements of ISO 8536-1. The suspension de

18、vices are intended for multiple use. The purpose of this International Standard is to establish a safe suspension device for infusion bottles during administering of their contents. 2 Normative references The following referenced documents are indispensable for the application of this document. For

19、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 Part 1: Tolerances for linear and angular dimensions without individual tolerance indications ISO 8536-1, Infusio

20、n equipment for medical use Part 1: Infusion glass bottles 3 Designation code and test weights Permanent suspension devices that comply with the requirements of this International Standard are designated by the description block, followed by a reference to this International Standard, followed by th

21、e nominal volume as specified in Table 1. For example, a permanent suspension device for an infusion bottle that conforms to the requirements of ISO 8536-1 of nominal capacity of 50 ml to 250 ml is designated as follows: Suspension device ISO 15375 - M 50 - 250 Test weights used for the permanent lo

22、ad test (see 6.4) are also a function of the nominal capacity of the permanent suspension device and are specified in Table 1. Table 1 Designation code and test weights for permanent load test Nominal capacity of the bottles ml Test weight at 24 h kg u 250 3 250 5 BS ISO 15375:2010ISO 15375:2010(E)

23、2 ISO 2010 All rights reserved4 Material Materials selected for the permanent suspension device shall ensure that all requirements given in Clause 5 can be met. Certain materials can be chemically and physically damaged by disinfectants. Therefore, attention should be given to selecting materials th

24、at are more inert towards disinfectants and less sensitive to stress cracking and thermal stress. 5 Requirements 5.1 Design 5.1.1 When tested in accordance with 6.1, the multiple suspension device shall enable the installation of the bottle with a perforated transfer set. The suspension device shall

25、 be designed in such a way that an unintentional removal from an infusion rack or set-up device is not possible. 5.1.2 The design of the suspension device shall guarantee that the bottle is in a perpendicular position with a maximum deviation of 15. 5.1.3 When tested in accordance with 6.2, the desi

26、gn of the suspension device shall guarantee that the bottle does not fall off at angles of up to 45. 5.1.4 The suspension device shall be resistant to corrosion and practically free from burrs. 5.2 Sterilization and disinfection The manufacturers manual shall contain information indicating how the s

27、uspension device shall be cleaned, sterilized and disinfected. 5.3 Load 5.3.1 Gravitational load When tested in accordance with 6.3, the permanent suspension device shall not detach from the infusion bottle. It shall not be damaged by the test. 5.3.2 Permanent load When tested in accordance with 6.4

28、, the multiple suspension device shall prevent the infusion bottle from falling. It shall not be damaged by the test. 5.4 Life cycle 5.4.1 If the design of the permanent suspension device or materials used in its construction have a limited life cycle u 5 y, the manufacturer shall define the storage

29、 conditions and the time period during which a permanent suspension device is considered to be in conformance with this International Standard. 5.4.2 In order to take different user conditions into consideration, the manufacturer shall define assessment criteria to enable the user to establish when

30、the suspension device is no longer usable. BS ISO 15375:2010ISO 15375:2010(E) ISO 2010 All rights reserved 36 Testing 6.1 Assembly test The bottle with the connected transfer set is attached to the suspension device, e.g. hung on a hook having characteristics in accordance with those shown in Figure

31、 1. Any deviation of the orientation of the bottle from the perpendicular is recorded. The assembly test shall be repeated with all bottle sizes that will be used with the suspension device. 6.2 Sloping test The suspension device assembled with the bottle and the perforated transfer set is tilted to

32、 an angle of 45. The bottle shall not drop off of the suspension device. The sloping test shall be repeated with all bottle sizes that will be used with the suspension device. General tolerances are in accordance with class “m” (medium) as defined in ISO 2768-1. Dimensions in millimetres Figure 1 Te

33、st hook 6.3 Gravitational test Attach the permanent suspension device, fitted with a filled infusion bottle complying with ISO 8536-1, to the test hook (see Figure 1). Attach one end of a cord to the upper part of the hook, and the other end to a separate fixed point. Hold the suspension device and

34、hook level with the fixed point and drop the assemblage such that the cord stops the fall of the suspension device when it is at a vertical distance of 30 cm from the fixed point. The suspension device is considered to pass the test if the requirements specified in 5.3.1 are met. 6.4 Permanent load

35、test Using a hook with a diameter of 4 mm, e.g. in accordance with Figure 1, load the multiple suspension device for 24 h at (23 2) C and (50 3) % relative humidity with a test weight in accordance with Table 1. The suspension device is considered to pass the test if the requirements specified in 5.

36、3.2 are met. BS ISO 15375:2010ISO 15375:2010(E) ICS 11.040.20 Price based on 3 pages ISO 2010 All rights reserved BS ISO 15375:2010This page has been intentionally left blank BS ISO15375:2010BSI GroupHeadquarters 389Chiswick High Road,London, W4 4AL, UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 - Br

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