1、July 2017 English price group 23No 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 11.040.25!%guM“2688242www.din.deDIN
2、 ISO 11040-4Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 110404:2015),English translation of DIN ISO 11040-4:2017-07Vorgefllte Spritzen Teil 4: Spritzenzylinder aus Glas fr Injektionsprparate und sterilisierte und vormontierte S
3、pritzen zur Abfllung (ISO 110404:2015),Englische bersetzung von DIN ISO 11040-4:2017-07Seringues prremplies Partie 4: Cylindres en verre pour produits injectables et seringues prassembles strilises prremplissables (ISO 110404:2015),Traduction anglaise de DIN ISO 11040-4:2017-07SupersedesDIN ISO 1104
4、04:200710www.beuth.deDocument comprises 59 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.07.17 2 Normative references 93 Terms and definitions 104 General requirements 114.1 Quality systems 114.2 Testing . 114.3 Documentation
5、 115 Syringe barrel .1null5.1 Design including dimensions . 125.2 Functional testing of Luer connection . 155.3 Material 155.4 Performance requirements . 155.4.1 Hydrolytic resistance 155.4.2 Annealing quality . 155.4.3 Lubrication of the inner surface 155.4.4 Flange breakage resistance 155.4.5 Luer
6、 cone breakage resistance . 166 Sterilized subassembled syringes ready for filling166.1 General 166.2 Sterility . 166.3 Pyrogenicity/endotoxins. 176.4 Particles 176.5 Additional requirements to specific components of sterilized subassembled syringes ready for filling 176.5.1 Barrel 176.5.2 Needle 18
7、6.5.3 Closure system 196.6 Closure system barrel integrity . 207 Packaging 208 Labelling .20Annex A (informative) Examples of types of sterilized subassembled syringes ready for filling 21Annex B (informative) Head designs .23Annex C (normative) Test methods for syringe barrels 25Annex D (informativ
8、e) Sample preparation for endotoxin and particulate determination 31Annex E (informative) Glide force test method to evaluate syringe lubrication 35Annex F (informative) Needle penetration test 38Annex G (normative) Test methods for closure systems 41Annex H (informative) Dye solution tightness test
9、56Bibliography .58Contents PageIntroduction 81 Scope . 9National foreword 3 National Annex (informative) Bibliography 4 .A comma is used as the decimal marker.DIN ISO 11040-4:2017-07 2Foreword 6National foreword This document (ISO 11040-7:4) has been prepared by Technical Committee ISO/TC 76 “Transf
10、usion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-0
11、3 AA “Packaging systems for loading and application of medical devices”. In addition to the legal units of measurement, this standard also uses the units “in” (inch) and “bar”. It should be noted that the Gesetz ber Einheiten im Messwesen (German Law on units in metrology) prohibits the use of these
12、 units for official and commercial purposes in Germany. Conversion: Non-SI unit SI unit Conversion in (inch) mm 1 inch = 25,4 mm bar Pa 1 bar = 105PaThe DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 178 DIN EN ISO 178 ISO 180 DIN EN ISO 1
13、80 ISO 527-2 DIN EN ISO 527-2 ISO 594-1 DIN EN 20594-1 ISO 594-2 DIN EN 1707 ISO 720:1985 DIN ISO 720:1989-12 ISO 2039-2 DIN EN ISO 2039-2 ISO 2859-1 DIN ISO 2859-1 ISO 3951 DIN ISO 3951-1 ISO 4802-1 DIN ISO 4802-1 ISO 4802-2 DIN ISO 4802-2 ISO 7619-1 DIN ISO 7619-1 ISO 7864 DIN EN ISO 7864 ISO 7886
14、-1:1993 DIN EN ISO 7886-1:1997-10 ISO 8871-1 DIN EN ISO 8871-1 ISO 9626 DIN EN ISO 9626 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-7 DIN EN ISO 10993-7 ISO 11040-5 DIN ISO 11040-5 ISO 11135-1 DIN EN ISO 11135-1 ISO 11137 (all parts) DIN EN ISO 11137 (all parts) ISO 11140 (all parts) DIN EN ISO 11140 (
15、all parts) ISO 11608-2 DIN EN ISO 11608-2 ISO 11608-5 DIN EN ISO 11608-5 ISO 14644-1 DIN EN ISO 14644-1 ISO 14937 DIN EN ISO 14937 ISO 15378 DIN EN ISO 15378 ISO 17665-1 DIN EN ISO 17665-1 ISO 23908 DIN EN ISO 23908 ISO 80369-1 DIN EN ISO 803691 ISO 80369-7 DIN EN ISO 80369-7 DIN ISO 11040-4:2017-07
16、 3 Amendments This standard differs from DIN ISO 11040-4:2007-10 as follows: a) the Scope has been extended by adding sterilized subassembled syringes ready for filling and relevant requirements as well as test methods; b) general requirements for quality systems, testing and documentation have been
17、 added; c) requirements on labelling have been revised; d) requirements on packaging have been added; e) requirements on syringes barrels have been revised; f) the standard has been editorially revised. Previous editions DIN 58358-4: 1992-08 DIN ISO 11040-4: 1996-08, 2007-10 National Annex NA (infor
18、mative) Bibliography DIN EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Lock fittings DIN EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements DIN EN IS
19、O 178, Plastics Determination of flexural properties DIN EN ISO 180, Plastics Determination of Izod impact strength DIN EN ISO 527-2, Plastics Determination of tensile properties Part 2: Test conditions for moulding and extrusion plastics DIN EN ISO 2039-2, Plastics Determination of hardness Part 2:
20、 Rockwell hardness DIN EN ISO 7864, Sterile hypodermic needles for single use Requirements and test methods DIN EN ISO 7886-1:1997-10, Sterile hypodermic syringes for single use Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995) DIN EN ISO 8871-1, Elastomeric p
21、arts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates DIN ISO 11040-4:2017-07 4 DIN EN ISO 9626, Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods DIN EN ISO 10993-1, Biological evaluation of medical
22、devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation
23、 and routine control of a sterilization process for medical devices DIN EN ISO 11137 (all parts), Sterilization of health care products Radiation DIN EN ISO 11140 (all parts), Sterilization of health care products Chemical indicators DIN EN ISO 11608-2, Needle-based injection systems for medical use
24、 Requirements and test methods Part 2: Needles DIN EN ISO 11608-5, Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions DIN EN ISO 14644-1, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle conc
25、entration DIN EN ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 15378, Primary packaging materials for medicinal products P
26、articular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DI
27、N EN ISO 23908, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling DIN EN ISO 80369-1, Small bore connectors for liquids and gases in healthcare applications Part 1: Genera
28、l requirements DIN EN ISO 80369-7, Small bore connectors for liquids and gases in healthcare applications Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications DIN ISO 720:1989-12, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification
29、(ISO 720:1985) DIN ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection DIN ISO 3951-1, Sampling procedures and charts for inspection by variables for percent nonconforming DIN ISO 4802-1, Glassware
30、Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification DIN ISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification DIN ISO 7619-1,
31、Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) DIN ISO 11040-5, Prefilled syringes Part 5: Plunger stoppers for injectables DIN ISO 11040-4:2017-07 5 ForewordISO (the International Organization for Standardization) is a worldwide f
32、ederation of national 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 co
33、mmittee. International 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
34、and those intended for 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, P
35、art 2 (see www.iso.org/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
36、the document will be in 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 te
37、rms and expressions related 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 informationThe committee responsible for this document is ISO/TC 76, Transfusion, infusion
38、and injection, and blood processing equipment for medical and pharmaceutical use.This third edition cancels and replaces the second edition (ISO 11040-4:2007), which has been technically revised and contains the following changes: Scope has been extended by adding sterilized subassembled syringes re
39、ady for filling and appropriate requirements, as well as test methods, have been included; general requirements have been added on quality systems, testing, and documentation; requirements on labelling have been revised; requirements on packaging have been added; requirements on syringes barrels hav
40、e been revised by adding requirements and related test methods for flange breakage resistance and Luer cone breakage resistance, adding requirements on lubrication, adding requirements and guidance on tolerances for Luer conical fittings, as well as on functional testing of Luer connections, and del
41、eting the clause on designation.ISO 11040 consists of the following parts, under the general title Prefilled syringes: Part 1: Glass cylinders for dental local anaesthetic cartridges Part 2: Plunger stoppers for dental local anaesthetic cartridges Part 3: Seals for dental local anaesthetic cartridge
42、sDIN ISO 11040-4:2017-07 6 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: Requireme
43、nts and test methods for finished prefilled syringesDIN ISO 11040-4:2017-07 7 IntroductionIn the past, ampoules and injection vials were mainly used for (parenteral) injectable products. However, for the injection of the products contained in those ampoules and vials, a hypodermic syringe combined w
44、ith the appropriate injection needle is also needed. This means the injectable product has to be transferred by the user into the hypodermic syringe before its final use. This procedure is not only time-consuming, but also presents a great number of possibilities for contamination.To ensure safe use
45、 of an injectable product, prefilled syringes for single use are on the market for many years. Without a doubt, such prefilled syringes permit immediate injection of the product contained after relatively simple handling. These syringes can also be used in injectors with automated functions where fu
46、rther and particular requirements apply.Based on the diameter of the prefilled syringes, appropriate components, such as rubber plungers, tip caps, needle shields, and other closure systems can also be standardized. In conjunction with the right sealing components, they offer a system for (parentera
47、l) injectable use. The producers of filling machines can apply this part of ISO 11040 to achieve a degree of standardization in the equipment of the machines.At the start of prefilled syringe processing by the pharmaceutical industry, syringes made of tubing glass were delivered to the pharmaceutica
48、l companies in the form of so called non-sterile “bulkware” only. The process steps washing, drying, inner lubrication, sealing the syringe with a closure system, sterilization, as well as filling and closing, were then performed in the pharmaceutical companies. Processing of “bulkware” is performed
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