ISO 10985:2009 注入ボトルと注入バイアル用のアルミニウムとプラスチックの組み合わせで作られたキャップ—要件とテスト方法 | 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 10985 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.

This third edition cancels and replaces the second edition (ISO 10985:1999) Clause 2 of which has been updated.

Introduction

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

1 Scope

This International Standard specifies general requirements and test methods for caps made of aluminium-plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4.

The purpose of this International Standard is to specify caps that provide:

• a) guarantee of originality of the closure up to the point of administration;
• b) compression of the sealing element (rubber closure) on to the sealing surfaces of the infusion and/or injection bottles;
• c) protection of the sealing element against soiling and mechanical damage;
• d) simple and injury-free opening of the closure in order to expose the penetration area of the rubber closure and/or to permit total removal of the cap.

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.