ISO 9187-2:2010 医療用注射器具—パート2：ワンポイントカット（OPC）アンプル | 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, 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 9187-2 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 9187-2:1993), which has undergone a minor revision with the following modifications:

• the reference to ISO 9187-1 has been updated;
• the diameter of the point has been designated d₈ (instead of d₇) to be in line with the designation in ISO 9187-1.

ISO 9187 consists of the following parts, under the general title Injection equipment for medical use:

• Part 1: Ampoules for injectables
• Part 2: One-point-cut (OPC) ampoules

Introduction

Ampoules are suitable packaging materials for storing pharmaceutical products until they are administered to the patient. Owing to the direct contact between injectables and the primary container over extended storage periods, possible interactions are to be avoided in order to guarantee patient safety. Adequate means to achieve this objective include proper selection of primary packaging materials, the choice of suitable package design and the availability of specific requirements and methods for testing individual container systems.

1 Scope

This part of ISO 9187 specifies materials, dimensions and requirements for forms of one-point-cut (OPC) ampoules (forms B, C and D) for injectables.

Ampoules complying with this part of ISO 9187 are intended for single use only.

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.