DIN ISO 15375-2014 Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods (ISO 15375 2010)《医用输液瓶 多用途悬吊装置 要求和试验方法 (ISO 15375-2010)》.pdf

1、October 2014Translation by DIN-Sprachendienst.English price group 6No part of this translation 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

2、11.040.20!%;?“2249428www.din.deDDIN ISO 15375Medical infusion bottles Suspension devices for multiple use Requirements and test methods (ISO 15375:2010),English translation of DIN ISO 15375:2014-10Medizinische Infusionsflaschen Aufhngevorrichtungen zur mehrmaligen Verwendung Anforderungen und Prfver

3、fahren (ISO 15375:2010),Englische bersetzung von DIN ISO 15375:2014-10Flacons mdicaux de transfusion et de perfusion Dispositifs de suspension usage multiple Exigences et mthodes dessai (ISO 15375:2010),Traduction anglaise de DIN ISO 15375:2014-10SupersedesDIN ISO 15375:2006-03www.beuth.deIn case of

4、 doubt, the German-language original shall be considered authoritative.Document comprises 7 pages09.14 A comma is used as the decimal marker. Contents Page National foreword .3 National Annex NA (informative) Bibliography .3 Introduction .5 1 Scope .5 2 Normative references .5 3 Designation code and

5、 test weights 5 4 Material 6 5 Requirements 6 5.1 Design 6 5.2 Sterilization and disinfection .6 5.3 Load .6 5.4 Life cycle .6 6 Testing .7 6.1 Assembly test .7 6.2 Sloping test .7 6.3 Gravitational test 7 6.4 Permanent load test .7 DIN ISO 15375:2014-102National foreword The text of this document (

6、ISO 15375:2010) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN St

7、andards Committee Medicine), Working Committee NA 063-02-03 AA Verpackungssysteme fr die Befl-lung und Applikation von medizinischen Produkten. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 2768-1 DIN ISO 2768-1 ISO 8536-1 DIN EN ISO

8、8536-1 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN and/or DKE shall not be held responsible for identifying any or all such patent rights. Amendments This standard differs from DIN ISO 15375:2006-03 as follows: a) normativ

9、e references have been updated; b) the standard has been editorially revised. Previous editions DIN 58379: 2000-03 DIN ISO 15375: 2006-03 National Annex NA (informative) Bibliography DIN ISO 2768-1, General tolerances Tolerances for linear and angular dimensions without individual tolerance indicati

10、ons DIN EN ISO 8536-1, Infusion equipment for medical use Part 1: Infusion glass bottles DIN ISO 15375:2014-103 This page is intentionally blank DIN ISO 15375:2014-104Medical infusion bottles Suspension devices for multiple use Requirements and test methods Introduction This International Standard d

11、eals with permanent suspension devices for multiple use 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. 1 Scope This International Standard specifies re

12、quirements 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 devices are intended for multiple use. The purpose of this International Standard is to establish a safe suspension device for i

13、nfusion bottles during administering of their contents. 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, the latest edition of the referenced document (inclu

14、ding any amendments) applies. ISO 2768-1, General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications ISO 8536-1, Infusion equipment for medical use Part 1: Infusion glass bottles 3 Designation code and test weights Permanent suspension devices th

15、at comply with the requirements of this International Standard are designated by the description block, followed by a reference to this International Standard, followed by the nominal volume as specified in Table 1. For example, a permanent suspension device for an infusion bottle that conforms to t

16、he 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 load test (see 6.4) are also a function of the nominal capacity of the permanent suspension device and are specified in Table 1.

17、 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 DIN ISO 15375:2014-1054 Material Materials selected for the permanent suspension device shall ensure that all requirements given in Clause 5 can be met. Certain

18、materials can be chemically and physically damaged by disinfectants. Therefore, attention should be given to selecting materials that 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

19、 multiple suspension device shall enable the installation of the bottle with a perforated transfer set. The suspension device shall 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 guarante

20、e 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 design 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 prac

21、tically free from burrs. 5.2 Sterilization and disinfection The manufacturers manual shall contain information indicating how the suspension 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 shal

22、l 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, 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

23、 suspension device or materials used in its construction have a limited life cycle u 5 y, the manufacturer shall define the storage 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 di

24、fferent user conditions into consideration, the manufacturer shall define assessment criteria to enable the user to establish when the suspension device is no longer usable. DIN ISO 15375:2014-1066 Testing 6.1 Assembly test The bottle with the connected transfer set is attached to the suspension dev

25、ice, e.g. hung on a hook having characteristics in accordance with those shown in Figure 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

26、suspension device assembled with the bottle and the perforated transfer set is tilted to 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

27、 with class “m” (medium) as defined in ISO 2768-1. Dimensions in millimetres Figure 1 Test 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 o

28、f the hook, and the other end to a separate fixed point. Hold the suspension device and 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 conside

29、red to pass the test if the requirements specified in 5.3.1 are met. 6.4 Permanent load 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 5.3.2 are met. DIN ISO 15375:2014-107