DIN ISO 11040-5-2013 Prefilled syringes - Part 5 Plunger stoppers for injectables (ISO 11040-5 2012)《预灌装注射器 第5部分 注射剂用柱塞(ISO 11040-5-2012)》.pdf
《DIN ISO 11040-5-2013 Prefilled syringes - Part 5 Plunger stoppers for injectables (ISO 11040-5 2012)《预灌装注射器 第5部分 注射剂用柱塞(ISO 11040-5-2012)》.pdf》由会员分享,可在线阅读,更多相关《DIN ISO 11040-5-2013 Prefilled syringes - Part 5 Plunger stoppers for injectables (ISO 11040-5 2012)《预灌装注射器 第5部分 注射剂用柱塞(ISO 11040-5-2012)》.pdf(11页珍藏版)》请在麦多课文档分享上搜索。
1、December 2013 Translation by DIN-Sprachendienst.English price group 8No 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).IC
2、S 11.040.25!%*OM“2074442www.din.deDDIN ISO 11040-5Prefilled syringes Part 5: Plunger stoppers for injectables (ISO 11040-5:2012),English translation of DIN ISO 11040-5:2013-12Vorgefllte Spritzen Teil 5: Kolbenstopfen fr Injektionsprparate (ISO 11040-5:2012),Englische bersetzung von DIN ISO 11040-5:2
3、013-12Seringues prremplies Partie 5: Bouchons-pistons pour produits injectables (ISO 11040-5:2012),Traduction anglaise de DIN ISO 11040-5:2013-12SupersedesDIN ISO 11040-5:2003-03www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1111.
4、13 DIN ISO 11040-5:2013-12 A comma is used as the decimal marker. Contents Page National foreword .3 National Annex NA (informative) Bibliography 5 Introduction .6 1 Scope 7 2 Normative references 7 3 Classification 7 4 Shape and dimensions 7 5 Designation 9 6 Material .10 7 Requirements .10 7.1 Gen
5、eral 10 7.2 Physical requirements 10 7.2.1 Hardness .10 7.2.2 Resistance to ageing .10 7.3 Chemical requirements .10 7.4 Biological requirements 10 8 Labelling .10 Bibliography 11 2 DIN ISO 11040-5:2013-12 National foreword This document (ISO 11040-5:2012) has been prepared by Technical Committee IS
6、O/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 Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-15 AA Elast
7、omere Pharmapackmittel und zugehrige Komponenten. 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. It should be noted that this standard in
8、cludes two National footnotes referring to other parts of this standard and one to explain an abbreviation in the English reference version. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 48 DIN ISO 48 ISO 3302-1 DIN ISO 3302-1 ISO 330
9、2-2 DIN ISO 3302-2 ISO 7619-1 DIN ISO 7619-1 ISO 8362-5 DIN ISO 8362-5 ISO 8871-1 DIN EN ISO 8871-1 ISO 8871-4 DIN EN ISO 8871-4 ISO 9997 DIN EN ISO 9997 ISO 11040-4 DIN ISO 11040-4 ISO 15378 DIN EN ISO 15378 DIN ISO 11040 consists of the following parts, under the general title Prefilled syringes:
10、Part 1: Glass cylinders for dental local anaesthetic cartridges Part 2: Plunger stoppers for dental local anaesthetic cartridges Part 3: Aluminium caps for dental local anaesthetic cartridges Part 4: Glass barrels for injectablesN1) Part 5: Plunger stoppers for injectables Part 6: Plastics barrels f
11、or injectablesN2) Part 7: Packaging systems for prefillable ready-to-use syingesN2)N1) National footnote: This part of the standards series is currently under revision. N2) National footnote: This part of the standards series is currently in preparation. 3 DIN ISO 11040-5:2013-12 4 Amendments This s
12、tandard differs from DIN ISO 11040-5:2003-03 as follows: a) the title of this part of ISO 11040 has been adjusted; b) this International Standard has been brought in line with the ISO 8871 series; c) the requirements on the height of the spacers and on material and hardness of the plunger stoppers h
13、ave been revised; d) Table 1 “Dimensions of plunger stoppers” has been supplemented by the missing value of the nominal dimensions of h1(13,45 up to 13,50) with d2(19,05 0,2); e) requirements on resistance to ageing have been added; f) in the German version, the translation of PSL has been adjusted
14、to the new spelling in ISO 11040-5; g) the standard has been editorially revised. Previous editions DIN 58358-5: 1992-11 DIN ISO 11040-5: 1996-08, 2003-03 DIN ISO 11040-5:2013-12 National Annex NA (informative) Bibliography DIN ISO 48, Rubber, vulcanized or thermoplastic Determination of hardness (h
15、ardness between 10 IRHD and 100 IRHD) DIN ISO 3302 (all parts), Rubber Tolerances for products DIN ISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) DIN ISO 8362-5, Injection containers and accessories Part 5: Freeze dryin
16、g closures for injection vials DIN EN ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates DIN EN ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test
17、 methods DIN EN ISO 9997, Dental cartridge syringes DIN EN ISO 15378, Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) DIN ISO 11040-4, Prefilled syringes Part 4: Glass barrels for inj
18、ectables 5 Introduction Primary packaging components made of elastomeric materials are an integral part of medicinal products. Therefore, the principles of current good manufacturing practices (cGMPN3) apply to the manufacturing of these components. Principles of cGMP are described in e.g. ISO 15378
19、 or in the GMP Guidelines published by the European Community and the United States of America. N3) National footnote: cGMP, en: current Good Manufacturing PracticeDIN ISO 11040-5:2013-12 6 Prefilled syringes Part 5: Plunger stoppers for injectables 1 ScopeThis part of ISO 11040 specifies the shape,
20、 dimensions, material, performance requirements and labelling of plunger stoppers for glass barrels (single-chamber design) for injection preparations in accordance with ISO 11040-4.Plunger stoppers specified in this part of ISO 11040 are intended for single use only.This part of ISO 11040 is not ap
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