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醫(yī)療和制藥用輸液、輸液和注射設備技術(shù)委員會編制。

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），該版本已經(jīng)過技術(shù)修訂。

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.

與上一版相比，主要變化如下：

-為圖1中的*45°倒角添加一個備選方案：

-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網(wǎng)站上找到。

關于本文件的任何反饋或問題都應提交給用戶的國家標準機構(gòu)。這些機構(gòu)的完整清單可在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.

本文件旨在規(guī)定醫(yī)用玻璃瓶的尺寸、容量、形狀和要求。由玻璃管制成的容器被認為適用于可注射制劑的包裝和儲存，直到它們被用于醫(yī)療目的。此類容器可由不同類型的玻璃制成，其可影響耐化學性； 例如，由硼硅酸鹽玻璃制成的玻璃具有很高的耐化學性，而由鈉鈣玻璃制成的玻璃則具有較低但足夠的耐化學性?？赏ㄟ^在生產(chǎn)過程中進行處理來提高由鈉鈣玻璃制成的容器內(nèi)表面的耐化學性，該處理旨在產(chǎn)生與由硼硅酸鹽玻璃制成的一次性容器的耐化學性相等的耐化學性。只要內(nèi)表面不被化學侵蝕破壞，這種耐化學侵蝕性就可以保持，在這種情況下，內(nèi)表面會降低到未經(jīng)處理的鈉鈣玻璃的水平。

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.

由于容器可由不同類型的玻璃制成，且當容器內(nèi)填充可注射制劑時，內(nèi)表面的化學行為非常重要，因此有必要規(guī)定可測量該性能的試驗程序。本文件中建議的程序允許根據(jù)待測量的耐水解性進行此性能，并且根據(jù)測量結(jié)果，可以將容器分類為正確的類別。該程序還允許對容器進行測試，并在中間階段后確定耐水解性是由作為材料的玻璃成分產(chǎn)生還是由內(nèi)表面處理產(chǎn)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范圍

本文件規(guī)定了注射制劑用玻璃瓶的形狀、尺寸和容量。還規(guī)定了制造此類容器的材料以及這些容器的性能要求。

本文件適用于由硼硅酸鹽或鈉硅酸鹽玻璃制成的無色或琥珀色玻璃容器，由玻璃管制成，無論是否經(jīng)過內(nèi)部表面處理，用于包裝、儲存或運輸注射用產(chǎn)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 規(guī)范性引用文件

以下文件在文中引用時，其部分或全部內(nèi)容構(gòu)成本文件的要求。凡是注日期的引用文件，僅引用的版本適用。凡是不注日期的引用文件，其最新版本[包括任何修改件]適用。

ISO 719，玻璃-玻璃顆粒在98℃下的耐水解性-試驗方法和分類

ISO 720，玻璃-玻璃顆粒在121℃下的耐水解性-試驗方法和分類

ISO 4802-1，玻璃器皿-玻璃容器內(nèi)表面的耐水解性-第1部分：滴定法測定和分類

ISO 4802-2，玻璃器皿-玻璃容器內(nèi)表面的耐水解性-第2部分：火焰光譜法測定和分類

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/