ISO 8362-7:2006 注射容器と付属品—パート7：プラスチック部分が重ならないアルミニウムとプラスチックの組み合わせで作られた注射キャップ | ページ 2

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 8362-7 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.

This second edition cancels and replaces the first edition (ISO 8362-7:1995), of which it constitutes a minor revision.

ISO 8362 consists of the following parts, under the general title Injection containers and accessories:

• Part 1: Injection vials made of glass tubing
• Part 2: Closures for injection vials
• Part 3: Aluminium caps for injection vials
• Part 4: Injection vials made of moulded glass
• Part 5: Freeze drying closures for injection vials
• Part 6: Caps made of aluminium-plastics combinations for injection vials
• Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part

Introduction

The materials from which injection containers (including elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. However, in this part of ISO 8362, injection caps are not considered as primary packaging materials in direct contact with pharmaceutical preparations.

During the processing of injection vials 2R and 4R, according to ISO 8362-1, and injection vials 6R, 8R, 10I, 5H, 7H and 8H, according to ISO 8362-1 and ISO 8362-4 respectively, difficulties may arise when using injection caps made of aluminium-plastics combinations corresponding to ISO 8362-6 because the diameter d₂ of the plastics element is larger than the diameter d of the injection vial body.

In order to avoid problems during the automatic working process, e.g. labelling of the vials or intermediate storage on a turntable, injection caps made of aluminium-plastics combinations are designed in such a way that the plastics element does not overlap the diameter of the vial body.

1 Scope

This part of ISO 8362 specifies aluminium-plastics combinations for the injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4 ここで, the plastics part does not overlap the diameter of the vial body.

2 Normative references

The following referenced documents are indispensable for the application 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.