BS ISO 11418-5-2015 Containers and accessories for pharmaceutical preparations Dropper assemblies《药品配制用容器及附件 点滴器附件》.pdf

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1、BSI Standards PublicationBS ISO 11418-5:2015Containers and accessories forpharmaceutical preparationsPart 5: Dropper assembliesBS ISO 11418-5:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 11418-5:2015.The UK participation in its preparation was entrusted

2、 to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institu

3、tion 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 87017 0ICS 11.040.20; 11.120.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2015.Amend

4、ments issued since publicationDate T e x t a f f e c t e dBS ISO 11418-5:2015 ISO 2015Containers and accessories for pharmaceutical preparations Part 5: Dropper assembliesRcipients et accessoires pour prparations pharmaceutiques Partie 5: Compte-gouttesINTERNATIONAL STANDARDISO11418-5Second edition2

5、015-03-01Reference numberISO 11418-5:2015(E)BS ISO 11418-5:2015ISO 11418-5:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, elec

6、tronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. +

7、41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 11418-5:2015ISO 11418-5:2015(E)Foreword iv1 Scope . 12 Normative references 13 Dimensions and designation . 13.1 Dimensions . 13.1.1 Dropper bulb with small suction volume (DBS) . 33.1.2 Dropper

8、bulb with medium suction volume (DBM) . 43.1.3 Screw cap 53.1.4 Pipette . 63.2 Designation 73.2.1 Screw cap 73.2.2 Dropper bulb with small suction volume (DBS) . 73.2.3 Dropper bulb with medium suction volume (DBM) . 73.2.4 Pipette . 74 Material 74.1 Dropper bulb 74.2 Pipette. 84.3 Screw cap . 85 Re

9、quirements 85.1 Dropper bulb 85.2 Pipette. 8Bibliography 9 ISO 2015 All rights reserved iiiContents PageBS ISO 11418-5:2015ISO 11418-5:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepa

10、ring 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. International organizations, governmental and non-governmental, in l

11、iaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC D

12、irectives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that

13、 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent dec

14、larations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information

15、about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information .The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical

16、 use.This second edition cancels and replaces the first edition which has been revised in order to update the references.ISO 11418 consists of the following parts, under the general title Containers and accessories for pharmaceutical preparations: Part 1: Drop-dispensing glass bottles Part 2: Screw-

17、neck glass bottles for syrups Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Part 4: Tablet glass bottles Part 5: Dropper assemblies Part 7: Screw-neck vials made of glass tubing for liquid dosage formsiv ISO 2015 All rights reservedBS ISO 11418-5:2015Containers and acces

18、sories for pharmaceutical preparations Part 5: Dropper assemblies1 ScopeThis part of ISO 11418 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparation

19、s.This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1.Dropper assemblies are applicable to primary packs used in direct contact with the drug.NOTE The potency, pu

20、rity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its applicatio

21、n. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 719, Glass Hydrolytic resistance of glass grains at 98 degrees C Method of test and classificationISO 720, Glass Hydrolytic resistance

22、 of glass grains at 121 degrees C Method of test and classificationISO 8362-2, Injection containers and accessories Part 2: Closures for injection vialsISO 11418-1, Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles3 Dimensions and designation3.1 Dimensi

23、onsThe design of the dropper assembly (see Figure 1) may vary, however the dimensions shall be as shown in Figures 2, 3, 4 and 5 and as given in Tables 1, 2, 3 and 4.Application shall be directed to the location indicated from the diagnostic or therapeutic point of view and shall enable dosage in dr

24、ops.INTERNATIONAL STANDARD ISO 11418-5:2015(E) ISO 2015 All rights reserved 1BS ISO 11418-5:2015ISO 11418-5:2015(E)Key1 dropper bulb2 screw cap3 pipette4 screw neck bottleFigure 1 Typical dropper assembly2 ISO 2015 All rights reservedBS ISO 11418-5:2015ISO 11418-5:2015(E)3.1.1 Dropper bulb with smal

25、l suction volume (DBS)Dimensions in millimetresFigure 2 Dropper bulb with small suction volume ISO 2015 All rights reserved 3BS ISO 11418-5:2015ISO 11418-5:2015(E)3.1.2 Dropper bulb with medium suction volume (DBM)Dimensions in millimetresFigure 3 Dropper bulb with medium suction volumeTable 1 Volum

26、e and dimensions of dropper bulbDimensions in millimetresTypeVolume mld10,15d20,2d30,2d40,2d50,2h10,5h20,2DBS 0,15 15,0 8,5 7,5 6,0 9,6 24,0 4,3DBM 0,6 15,6 11,8 8,5 6,7 13,3 23,5 4,34 ISO 2015 All rights reservedBS ISO 11418-5:2015ISO 11418-5:2015(E)3.1.3 Screw capDimensions in millimetresFigure 4

27、Screw capTable 2 Diameter D in relationship to dropper bulb suction volumeDimensions in millimetresDropper bulb suction volumeD 0,2Small (DBS) 8,5Medium (DBM) 12 ISO 2015 All rights reserved 5BS ISO 11418-5:2015ISO 11418-5:2015(E)3.1.4 PipetteDimensions in millimetresFigure 5 PipetteTable 3 Diameter

28、 of the pipetteDimensions in millimetresTyped10,15d20,25x max.DBS 6,35 7,75 6,6DBM 7,25 8,25 7,56 ISO 2015 All rights reservedBS ISO 11418-5:2015ISO 11418-5:2015(E)Table 4 Length of pipetteDimensions in millimetresNominal volume of screw neck bottle in accordance with ISO 11418-1 mlLength/l1 0,5DBS

29、DBM5 41,5 4510 47,5 5115 59 62,520 59 62,525 59 6130 66 69,550 83 86,575 87,5 91100 90,5 943.2 Designation3.2.1 Screw capDesignation of a screw cap, type (DBS) complying with the requirements in this part of ISO 11418:Screw cap ISO 11418-5 DBS3.2.2 Dropper bulb with small suction volume (DBS)Designa

30、tion of a dropper bulb with small suction volume (DBS) complying with the requirements in this part of ISO 11418:Dropper bulb ISO 11418-5 DBS3.2.3 Dropper bulb with medium suction volume (DBM)Designation of a dropper bulb with medium suction volume (DBM) complying with the requirements in this part

31、of ISO 11418:Dropper bulb ISO 11418-5 DBM3.2.4 PipetteDesignation of a pipette for screw neck bottles in accordance with ISO 11418-1 with a nominal volume (25 ml) and type (DBS) complying with the requirements in this part of ISO 11418:Pipette ISO 11418-5 25-DBS4 Material4.1 Dropper bulbThe dropper

32、bulb shall be of an elastomeric material.The material itself and its hardness shall be agreed between manufacturer and customer. ISO 2015 All rights reserved 7BS ISO 11418-5:2015ISO 11418-5:2015(E)4.2 Pipette4.2.1 The pipette shall be of colourless borosilicate glass1)or soda lime-silica glass1)(but

33、 see also 4.2.2) of one of the following hydrolytic resistance grain classes:a) ISO 719 HGB 1b) ISO 719 HGB 3 or ISO 720 HGA 2.4.2.2 The use of thermoplastics instead of glass is permitted provided it is agreed upon between manufacturer and user.4.3 Screw capThe screw cap shall be of a plastics mate

34、rial which is agreed between manufacturer and user.5 Requirements5.1 Dropper bulbThe dropper bulb shall be in accordance with the chemical and biological requirements given in ISO 8362-2.5.2 PipetteThe design of the pipette tip shall be agreed between manufacturer and customer.1) Definitions are giv

35、en in ISO 4802-1 and ISO 4802-2.8 ISO 2015 All rights reservedBS ISO 11418-5:2015ISO 11418-5:2015(E)Bibliography1 ISO 4802 (all parts), Glassware Hydrolytic resistance of the interior surfaces of glass containers2 ISO 8871 (all parts), Elastomeric parts for parenterals and for devices for pharmaceut

36、ical use ISO 2015 All rights reserved 9BS ISO 11418-5:2015ISO 11418-5:2015(E) ISO 2015 All rights reservedICS 11.120.99; 11.040.20Price based on 9 pagesThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, info

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