ISO 8872:2022 輸液ボトルおよび注射バイアル用のアルミニウム製キャップおよびアルミニウム/プラスチック製キャップ — 一般的な要件と試験方法 | 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.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, 2 (see www.iso.org/directives ).

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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html .

This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/SS S02, Transfusion equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This third edition cancels and replaces the second edition (ISO 8872:2003) and ISO 10985:2009, which have been technically revised.

The main changes are as follows:

• integration of ISO 10985;
• addition of new terms;
• addition of a new Annex A,"Aluminium and aluminium plastic caps - Type drawings";
• addition of a new Annex B,"Opening and tear-off forces".

Introduction

The primary materials from which containers, including their elastomeric closures, are made must be suitable for the storage of such products until the products are administered. However, in this document, aluminium caps and aluminium/plastic caps are not considered as primary packaging materials that will come into direct contact with pharmaceutical preparations. Aluminium and aluminium/plastic caps can be delivered to customers as non-sterile products or as sterile products.

1 Scope

This document specifies general requirements and test methods for aluminium caps and aluminium/plastic caps intended for use on infusion bottles and/or injection vials.

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 following terms and definitions apply.

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

Bibliography