BS ISO 11040-1-2015 Prefilled syringes Glass cylinders for dental local anaesthetic cartridges《预灌装注射器 牙齿局部麻醉器玻璃管》.pdf

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1、BSI Standards PublicationBS ISO 11040-1:2015Prefilled syringesPart 1: Glass cylinders for dental localanaesthetic cartridgesBS ISO 11040-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 11040-1:2015. It supersedes BS 7652-1:1993 which is withdrawn.The UK

2、participation in its preparation was entrusted 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 cor

3、rectapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 87576 2ICS 11.040.10; 11.040.25; 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStanda

4、rds Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 11040-1:2015 ISO 2015Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridgesSeringues prremplies Partie 1: Tubes en verre pour cartouches

5、dentaires danesthsie localeINTERNATIONAL STANDARDISO11040-1Second edition2015-12-01Reference numberISO 11040-1:2015(E)BS ISO 11040-1:2015ISO 11040-1:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise specified, n

6、o part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic 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 memb

7、er body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 11040-1:2015ISO 11040-1:2015(E)Foreword iv1 Scope .12 Normative references 13 Dimensions and designatio

8、n .13.1 Dimensions . 13.2 Designation 24 Requirements 24.1 Material . 24.2 Performance 25 Marking 2Bibliography 4 ISO 2015 All rights reserved iiiContents PageBS ISO 11040-1:2015ISO 11040-1:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national

9、standards bodies (ISO member bodies). The work of preparing 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

10、 organizations, governmental and non-governmental, in liaison 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

11、 its further maintenance are described in the ISO/IEC Directives, 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

12、/directives).Attention is drawn to the 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. Details of any patent rights identified during the development of the document will be i

13、n the Introduction and/or on the ISO list of patent declarations 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 re

14、lated to conformity assessment, as well as information 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 bl

15、ood processing equipment for medical and pharmaceutical use.This second edition cancels and replaces the first edition (ISO 11040-1:1992), which has been technically revised with the following changes: including glass cylinders of 2,2 ml size; amending the requirements on performance and marking; ed

16、itorial revision of this part of ISO 11040-1.ISO 11040 consists of the following parts, under the general title Prefilled syringes: Part 1: Glass cylinders for dental local anaesthetic cartridges Part 2: Plungers stoppers for dental local anaesthetic cartridges Part 3: Seals for dental local anaesth

17、etic cartridges Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling Part 5: Plunger stoppers for injectables Part 6: Plastics barrels for injectables Part 7: Packaging systems for sterilized subassembled syringes ready for filling Part 8: Requirements and tes

18、t methods for finished prefilled syringesiv ISO 2015 All rights reservedBS ISO 11040-1:2015INTERNATIONAL STANDARD ISO 11040-1:2015(E)Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges1 ScopeThis part of ISO 11040 specifies the design, dimensions, materials, performanc

19、e and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only.NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499.It applies to primary packs used in direct contact with a drug.NOTE 2 The potency, purity

20、, 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 application. Fo

21、r dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 720, Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classificationISO 48021, Glassware Hydrolytic resistan

22、ce of the interior surfaces of glass containers Part 1: Determination by titration method and classificationISO 48022, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification3 Dimensions and designation3.1 Dimensions

23、The dimensions of the glass cylinder shall be as shown in Figure 1.Variations of the design of the truncated cone are allowed, if at the same time, the following conditions are fulfilled: truncated cone has the height of the neck length (5 0,2) mm; stated tolerances of the neck opening are maintaine

24、d; diameter of the neck opening at the inner end and at the cone may be a maximum of 0,3 mm smaller than the top (3,15 0,15) mm. ISO 2015 All rights reserved 1BS ISO 11040-1:2015ISO 11040-1:2015(E)3.2 DesignationGlass cylinders for dental local anaesthetic cartridges shall be designated by a referen

25、ce to this part of ISO 11040, followed by the colour of the glass.EXAMPLE A glass cylinder for dental local anaesthetic cartridges (cylinder), made of clear glass (cl) tubing of hydrolytic resistance container class ISO 48021 and ISO 48022 HC 1, in accordance with this part of ISO 11040 is designate

26、d as follows:Glass cylinders for dental local anaesthetic cartridges ISO 110401 cl4 Requirements4.1 MaterialThe material shall be colourless (cl) glass of hydrolytic resistance grain class ISO 720 HGA 1.A change in the chemical composition of the glass material should be notified to the user at leas

27、t nine months in advance.4.2 Performance4.2.1 Glass cylinders made of glass tubing should have a sealing surface at the open end of the neck which is flat and free from ripples or undulations which would affect the sealing performance.4.2.2 Glass cylinders should not contain seed or bubbles to an ex

28、tent which will interfere with the visual examination of the contents.4.2.3 Glass cylinders should not have open air lines on the inside surface which can lead to leakages.4.2.4 When tested in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal surface of the glass cy

29、linder shall comply with the requirements of the hydrolytic resistance container class ISO 4802 HC 1.Before conducting the test, the bottom end of the cylinder shall be sealed with a suitable closure element, e.g. silicon rubber.4.2.5 If the glass cylinder is annealed, the maximum residual stress sh

30、all not produce an optical retardation exceeding 40 nm/mm of glass thickness.The test method shall be agreed upon between the glass manufacturer and the customer.5 MarkingThe outer packaging of the glass cylinders shall be marked with the following information:a) size of the glass cylinder;b) number

31、 of cylinders it contains;c) designation of the cylinders;d) name or symbol of the manufacturer;e) lot number (only if the cylinder is printed) or date of production.Other markings on the outer packaging are subject to agreement between the manufacturer and the customer.2 ISO 2015 All rights reserve

32、dBS ISO 11040-1:2015ISO 11040-1:2015(E)Dimensions in millimetresKeyl length of the glass cylinder are as follows:(62,4 0,4) mm for 1,7 ml/1,8 ml glass cylindersc(75,0 0,4) mm for 2,2 ml glass cylinderscaDimension 3,15 mm 0,15 mm over a depth of 5 mm 0,2 mm, but see also 3.1.bSlightly rounded.cDesign

33、ation of volume either as filled-in volume or removable volume.NOTE Any deviations are subject to agreement between the manufacturer and the customer.Figure 1 Typical glass cylinder for dental local anaesthetic cartridges ISO 2015 All rights reserved 3BS ISO 11040-1:2015ISO 11040-1:2015(E)Bibliograp

34、hy1 ISO 11499, Dentistry Single-use cartridges for local anaesthetics4 ISO 2015 All rights reservedBS ISO 11040-1:2015BS ISO 11040-1:2015ISO 11040-1:2015(E) ISO 2015 All rights reservedICS 11.040.10; 11.040.25; 11.060.20Price based on 4 pagesThis page deliberately left blankBSI is the national body

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