BSISO11418-7:2016 IS011418-7:2016(E) Foreword Iso(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandards bodies (Iso member bodies). The work of preparing International Standards is normally carried out throughIsotechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnical committee has been established has the right to berepresented on that committee. International ISo collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnicalstandardization. The procedures used to develop this document and those intended for its further maintenance are described inthe Iso/IEC Directives,Part 1.In particularthe differentapproval criteria neededfor the differenttypes ofIsodocuments should be noted.This document was drafted in accordance with the editorialrulesoftheISo/lEcDirectives,Part2 (seewww.iso.org/directives). Attentionis drawntothepossibilitythat someof theelementsofthisdocumentmaybethe subjectof patent rights. Iso shall not be held responsible for identifying any or all such patent rights.Details of anypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/or on the Iso list of patent declarations received (see www.iso.org/patents) Any trade nameused in this document is information given for the convenience of users and does not constitutean endorsement. ForanexplanationonthemeaningofisO specifictermsandexpressionsrelatedtoconformityassessment, aswellasinformationaboutIsO'sadherencetotheWorldTradeOrganization(WTO)principlesinthe Technical Barriers to Trade (TBT) seethefollowing URL:Www.iso.org/iso/foreword.html The committeeresponsiblefor this document isIso/TC76,Transfusion,infusion and injection,andblood processing equipmentformedical andpharmaceutical use. This secondedition cancels and replacesthefirst edition (Is0 11418-7:1998),which has been technically revised by amending the mass of screw-neck vials in Table 1, and editoriallyrevisingthispartofIs011418. ISo 11418 consists of the following parts, under the general title Containers and accessories for pharmaceuticalpreparations: Part 1: Drop-dispensing glass bottles Part2:Screw-neckglassbottlesforsyrups Part3:Screw-neckglassbottles (veral)forsolidandliquiddosageforms Part4:Tabletglassbottles Part5:Dropperassemblies Part7:Screw-neckvials madeofglasstubingforliquiddosageforms iv IS0 2016-All rights reserved BS ISO 11418-7:2016 IS011418-7:2016(E) Introduction The purpose of this part of Iso11418 is to specify thedimensions, capacities, form and requirements of screw-neck vials made from tubular glass intended for medical use.Vials madefrom glass tubing areconsideredtobe suitableforthepackaging and storageof pharmaceutical preparationsuntil they are administeredformedicinal purposes. Such vials maybemade of different types of glass which can affectchemicalresistanceproperties.Forexample,thosemadefromborosilicateglasswillhaveavery high level of chemical resistance where others madefrom soda-lime-silica glass will have a lower but adequate chemicalresistanceforthepurposesforwhichtheyareintended. Becausevials maybe madefrom different types of glass and because it is the chemical behaviour of the internal surface which is important when they are filled with pharmaceutical preparations,it is essentialtospecifythetestproceduresbywhichtheperformancecanbemeasured. IS0 2016-All rights reserved BS ISO 11418-7:2016