1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 11040-3:2012Prefilled syringesPart 3: Seals for dental local anaestheticcartridgesBS ISO 11040-3:2012 BRITISH STANDARDNational forewordThis British Standard is the UK impl
2、ementation of ISO 11040-3:2012.The UK 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 contr
3、act. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 70606 6ICS 11.040.10; 11.040.25; 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was publ
4、ished under the authority of theStandards Policy and Strategy Committee on 29 February 2012.Amendments issued since publicationDate Text affectedBS ISO 11040-3:2012 ISO 2012Prefilled syringes Part 3:Seals for dental local anaesthetic cartridgesSeringues prremplies Partie 3: Rondelles dtanchit pour c
5、artouches dentaires danesthsie localeINTERNATIONAL STANDARDISO11040-3Second edition 2012-01-15Reference number ISO 11040-3:2012(E)BS ISO 11040-3:2012ISO 11040-3:2012(E)ii ISO 2012 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2012All rights reserved. Unless otherwise specified, no part of this
6、 publication may be reproduced or utilized in any form or by any means, electronic or mechanical, 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 officeCase postale 56 CH-1211 G
7、eneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 11040-3:2012ISO 11040-3:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work
8、 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 organizations, governmental and non-governmen
9、tal, 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.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main
10、 task of technical committees 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.Atten
11、tion 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.ISO 11040-3 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood p
12、rocessing equipment for medical and pharmaceutical use.This second edition cancels and replaces the first edition (ISO 11040-3:1993), which has been technically revised.ISO 11040 consists of the following parts, under the general title Prefilled syringes: Part 1: Glass cylinders for dental local ana
13、esthetic cartridges Part 2: Plunger stoppers for dental local anaesthetic cartridges Part 3: Seals for dental local anaesthetic cartridges Part 4: Glass barrels for injectables and ready-to-use prefillable syringes Part 5: Plunger stoppers for injectables Part 6: Plastics barrels for injectablesThe
14、following parts are under preparation: Part 7: Packaging systems for prefillable ready-to-use syringes ISO 2012 All rights reserved iiiBS ISO 11040-3:2012ISO 11040-3:2012(E)IntroductionPrimary packaging components made of elastomeric materials are an integral part of medicinal products. Therefore, t
15、he principles of current good manufacturing practices (cGMP) apply to the manufacturing of these components.Principles of cGMP are described in ISO 15378 or in the GMP Guidelines published by the European Community and the United States of America.iv ISO 2012 All rights reservedBS ISO 11040-3:2012Pr
16、efilled syringes Part 3: Seals for dental local anaesthetic cartridges1 ScopeThis part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only.NOTE The potency, purity, stability and
17、safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the editio
18、n cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 3302-1, Rubber Tolerances for products Part 1: Dimensional tolerancesISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer m
19、ethod (Shore hardness)ISO 7885:2010, Dentistry Sterile dental injection needles for single useISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavatesISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceuti
20、cal use Part 4: Biological requirements and test methodsISO 8871-5:2005, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testingISO 8872, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methodsI
21、SO 11040-1, Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridgesISO 11040-2, Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges3 ClassificationSeals shall be classified as follows: type A: seals with a mono-layer disc; type B: seals with
22、 a double-layer disc.4 Shape and dimensions4.1 The shape and dimensions of seals shall be as shown in Figure 1 and given in Table 1.INTERNATIONAL STANDARD ISO 11040-3:2012(E) ISO 2012 All rights reserved 1BS ISO 11040-3:2012ISO 11040-3:2012(E)Dimensions in millimetresType A: Seal with a mono-layer d
23、iscType B: Seal with a double-layer discShape and dimensions of seals for dental local anaesthetic cartridgesDimensions of sealsDimensions in millimetresNominal size Type Total cap heightaThickness of discInner cap diameterBore diameterh1h2d1d20,15 0,15 0,05 0,37,5 A 4,85 to 4,9 1,3 to 1,5 7,5 3,07,
24、5 B 4,85 to 5,3 1,45 to 1,95 7,5 3,0aThe height of the seal depends on the thickness and hardness of the disc.4.2 For type B seals, both single layers shall be continuous. The thickness ratio of the single layers shall be agreed upon between the supplier and user.4.3 The diameter of the rubber discs
25、 shall be such that a sufficient press-fit in the aluminium cap is achieved and that the discs cannot fall out.4.4 If not otherwise specified, general dimensional tolerances shall be in accordance with ISO 3302-1.2 ISO 2012 All rights reservedBS ISO 11040-3:2012ISO 11040-3:2012(E)5 DesignationSeals
26、are designated according to their type (see Clause 3 and Figure 1). The designation shall comprise, in the following order, the descriptor “Seal”, a reference to this part of ISO 11040 and the type letter.EXAMPLE Designation of a seal of type A (i.e. trimmed):Seal ISO 11040-3 - A6 Material6.1 CapGen
27、eral requirements for aluminium caps shall be in accordance with ISO 8872. In addition, the cap shall be anodized or suitably lacquered.6.2 DiscsDiscs shall be made from the elastomeric formulation originally tested and approved by the end user. The manufacturer of the discs shall ensure the conform
28、ance of each delivery with the type sample and the compliance with previously agreed functional and compendial requirements.The elastomeric material shall withstand two sterilization cycles when autoclaving in saturated steam at (121 2) C for 30 min without impairment of its function under condition
29、s of normal use. If other sterilization methods are used, e.g. irradiation, the suitability of the material shall be evaluated.7 Requirements7.1 GeneralThe requirements specified in 7.2 to 7.4 constitute minimum requirements concerning the condition of the elastomeric seals on receipt by the user.7.
30、2 Physical requirements7.2.1 Hardness of the discThe hardness agreed between the manufacturer and the user shall not differ from the nominal value by more than 5 Shore A when tested in accordance with ISO 7619-1 on a special test specimen. Alternatively, hardness can be tested on the discs in accord
31、ance with ISO 48. If tested according to ISO 48, the microhardness shall not differ by more than 5 IRHD from the type sample.The manufacturer should provide suitable test specimens upon request.7.2.2 FragmentationThe requirements and test method of ISO 8871-5:2005, 4.2 and Annex B, shall apply, usin
32、g a needle with an outer diameter of 0,4 mm that conforms to the butt-end requirements in ISO 7885:2010, 5.3.Schematic representation of butt-end angle ISO 2012 All rights reserved 3BS ISO 11040-3:2012ISO 11040-3:2012(E)7.2.3 Freedom from leakageThe seal of the cartridge shall show no signs of leaka
33、ge when tested in accordance with Annex A.7.2.4 Resistance to ageingThe maximum time between the date of manufacture of the seals and their pharmaceutical use should be agreed upon between the manufacturer and the user.The seals shall maintain their performance characteristics throughout the entire
34、shelf-life of the medicinal product, which is tested as part of the stability test by the user.NOTE Ageing depends on storage and handling conditions. A guide to storage of vulcanized rubber is given in ISO 2230.7.3 Chemical requirementsThe requirements of ISO 8871-1 shall apply for the disc.7.4 Bio
35、logical requirementsThe requirements of ISO 8871-4 shall apply.Toxicity tests apply to the disc only.8 LabellingPacked seals that meet the requirements of this part of ISO 11040 can be labelled with the designation given in Clause 5.4 ISO 2012 All rights reservedBS ISO 11040-3:2012ISO 11040-3:2012(E
36、)Annex A (normative) Leakage testA.1 PrincipleWater-filled cartridges are prepared using the seals to be tested. By means of a suitable device, a force is applied to the seal during a defined time interval. Any observed leakage is recorded.The leakage tests for seals and plunger stoppers (see ISO 11
37、040-2) can be combined.A.2 ApparatusA.2.1 Cartridge cylinders, in accordance with ISO 11040-1.A.2.2 Seals to be tested.A.2.3 Plunger stoppers, in accordance with ISO 11040-2.A.2.4 Suitable equipment, to prepare water-filled cartridges.A.2.5 Cartridge holder, e.g. as specified in ISO 9997 or ISO 1149
38、9.A.2.6 Pressurizing device, capable of applying a force of (30 1) N.A.3 ProcedureA.3.1 Take 10 cartridges and fill them with water until they are practically air-free using the seals to be tested.NOTE The water may be replaced by a coloured solution in order to improve the visibility of the leakage
39、.A.3.2 Place the first cartridge, mounted in the cartridge holder (A.2.5), into the pressurizing device (A.2.6), and apply a force of (30 1) N for 1 min. Check for leakage at the seal.SAFETY PRECAUTIONS Adequate safety measures should be in place to protect the operator.A.3.3 Repeat the operation de
40、scribed in A.3.2 on the remaining cartridges.A.4 Expression of resultsReport the number of leakages observed at the seal.Report whether the testing of the seals and plunger stoppers (see ISO 11040-2) has been combined. ISO 2012 All rights reserved 5BS ISO 11040-3:2012ISO 11040-3:2012(E)Bibliography1
41、 ISO 48, Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)2 ISO 2230, Rubber products Guidelines for storage3 ISO 3302-2, Rubber Tolerances for products Part 2: Geometrical tolerances4 ISO 7405, Dentistry Evaluation of biocompatibility of medical d
42、evices used in dentistry5 ISO 9997, Dental cartridge syringes6 ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process7 ISO 11499, Dentistry Single-use cartridges for local anaesthetics8 ISO 13926-2, Pen systems Part 2: Plunger stoppers f
43、or pen-injectors for medical use9 ISO 15378, Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)6 ISO 2012 All rights reservedBS ISO 11040-3:2012BS ISO 11040-3:2012ISO 11040-3:2012(E) ISO
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