ISO 8362-1:2018 pdf free
ISO 8362-1:2018 pdf free.Injection containers and accessories – Injection vials made of glass tubing
This document specifies the form, dimensions and capacities of glass vials for injectable preparations.
It also specifies the material from which such containers are made and the performance requirements of those containers.
This document is applicable to colourless or amber glass containers made from borosillicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 719, Glass一Hydrolytic resistance of glass grains at 98 degrees C一Method of test and classification
ISO 720, Glass一Hydrolytic resistance of glass grains at 121 degrees C一Method of test and cassfication
ISO 4802-1, Glassware一Hydrolytic resistance of the interior surfaces of glass containers 一Part 1:Determination by titration method and classification
ISO 4802-2, Glassware一Hydrolytic resistance of the interior surfaces of glass containers一Part 2:Determination by flame spectrometry and classification
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IS0 4802-1 and ISO 4802-2 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
一ISO Online browsing platform: available at http://www.iso.org/obp
一IEC Electropedia: available at http://www.electropedia.org/
4 Dimensions
The dimensions of injection vials made of glass tubing shall meet the requirements of Figure 1, Figure 2 or Figure 3, as appropriate, and Table 1; the brimful capacity and mass shall be as shown in Table 1.
The opening of the vial should have a constant diameter, over the entire distance, h3, i.e. it should exhibit a cylindrical shape. A slightly conical shape can be accepted if the following requirements are fulfilled:
一the truncated cone has the height h3;
一the larger diameter is located at the flange or as agreed upon;
一the larger diameter does not exceed the smaller one by more than 0,3 mm.ISO 8362-1 pdf download.
