Injection containers and accessories —Part 1: Injection vials made of glass tubing

注射容器和附件.第1部分：玻璃管制注射瓶

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

本文件由ISO/TC 76医疗和制药用输液、输液和注射设备技术委员会编制。

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

本第四版取消并取代了第三版（ISO 8362-1:2009），该版本已经过技术修订。

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.

与上一版相比，主要变化如下：

-为图1中的*45°倒角添加一个备选方案：

-在表1中添加3R格式。

A list of all parts in the ISO 8362 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user's national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

ISO 8362系列中所有部分的列表可在ISO网站上找到。

关于本文件的任何反馈或问题都应提交给用户的国家标准机构。这些机构的完整清单可在www.iso.org/members.html上找到。

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.

本文件旨在规定医用玻璃瓶的尺寸、容量、形状和要求。由玻璃管制成的容器被认为适用于可注射制剂的包装和储存，直到它们被用于医疗目的。此类容器可由不同类型的玻璃制成，其可影响耐化学性； 例如，由硼硅酸盐玻璃制成的玻璃具有很高的耐化学性，而由钠钙玻璃制成的玻璃则具有较低但足够的耐化学性。可通过在生产过程中进行处理来提高由钠钙玻璃制成的容器内表面的耐化学性，该处理旨在产生与由硼硅酸盐玻璃制成的一次性容器的耐化学性相等的耐化学性。只要内表面不被化学侵蚀破坏，这种耐化学侵蚀性就可以保持，在这种情况下，内表面会降低到未经处理的钠钙玻璃的水平。

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 t reatment of the internal surface.

由于容器可由不同类型的玻璃制成，且当容器内填充可注射制剂时，内表面的化学行为非常重要，因此有必要规定可测量该性能的试验程序。本文件中建议的程序允许根据待测量的耐水解性进行此性能，并且根据测量结果，可以将容器分类为正确的类别。该程序还允许对容器进行测试，并在中间阶段后确定耐水解性是由作为材料的玻璃成分产生还是由内表面处理产生。

Injection containers and accessories—

Part1: Injection vials made of glass tubing

注射容器及配件-

第1部分：玻璃管制注射瓶

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 sodalime 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.

1范围

本文件规定了注射制剂用玻璃瓶的形状、尺寸和容量。还规定了制造此类容器的材料以及这些容器的性能要求。

本文件适用于由硼硅酸盐或钠硅酸盐玻璃制成的无色或琥珀色玻璃容器，由玻璃管制成，无论是否经过内部表面处理，用于包装、储存或运输注射用产品。

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 — Hydrolytic resistance of glass grains at 98 degrees C — Method of test and classification
ISO 720, Glass — Hydrolytic resistance of glass grains at 121 degrees C — Method of test and classification
ISO 4802-1, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification
ISO 4802-2, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification

2 规范性引用文件

以下文件在文中引用时，其部分或全部内容构成本文件的要求。凡是注日期的引用文件，仅引用的版本适用。凡是不注日期的引用文件，其最新版本[包括任何修改件]适用。

ISO 719，玻璃-玻璃颗粒在98℃下的耐水解性-试验方法和分类

ISO 720，玻璃-玻璃颗粒在121℃下的耐水解性-试验方法和分类

ISO 4802-1，玻璃器皿-玻璃容器内表面的耐水解性-第1部分：滴定法测定和分类

ISO 4802-2，玻璃器皿-玻璃容器内表面的耐水解性-第2部分：火焰光谱法测定和分类

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 1EC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/ohp
— I EC Electropedia: available at http://www.electropedia.org/