ISO 8362-1:2018 注射容器と付属品—パート1：ガラス管で作られた注射バイアル | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.

This fourth edition cancels and replaces the third edition (ISO 8362-1:2009), which has been technically revised.

The main changes compared to the previous edition are:

• add an alternative for a chamfer shaped with ≈45° in Figure 1;
• add a 3R format in Table 1.

A list of all parts in the ISO 8362 series can be found on the ISO website.

Introduction

The purpose of this document is to specify the dimensions, capacities, form and requirements of glass vials intended for medical use. Containers made from glass tubing are considered to be suitable for the packaging and storage of injectable preparations until they are administered for medicinal purposes. Such containers may be made from different types of glass which can affect the chemical resistance properties; e.g., those made from borosilicate glass will have a very high level of chemical resistance whereas others made from soda-lime glass will have a lower, but adequate, chemical resistance for the purpose for which they are intended. The chemical resistance of the internal surface of containers made from soda-lime glass can be improved by means of a treatment during production aimed at producing a chemical resistance equal to that of those made from borosilicate glass for single use. This level of chemical resistance is maintained as long as the interior surface is not destroyed by chemical attack, in which case it is reduced to that of untreated soda-lime glass.

Because containers may be made from different types of glass and because it is the chemical behaviour of the internal surface which is important when they are filled with injectable preparations, it is essential to specify test procedures by which this performance can be measured. The procedures recommended in this document permit this performance, based on the hydrolytic resistance to be measured and, from the result of measurement, it is possible to classify containers into their correct category. The procedure also allows containers to be tested and to determine, after an intermediate stage, whether the hydrolytic resistance is produced by the composition of the glass as a material or by a treatment of the internal surface.

1 Scope

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 borosilicate 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.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 4802-1 and ISO 4802-2 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography