ISO 8871-4:2006 非経口および医薬品用デバイス用のエラストマー部品—パート4：生物学的要件および試験方法 | 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.

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 8871-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.

This first edition, together with parts 1, 2, 3 and 5, cancels and replaces ISO 8871:1990 and ISO 8871:1990/Amd.1:1995, which has been technically revised.

ISO 8871 consists of the following parts, under the general title Elastomeric parts for parenterals and for devices for pharmaceutical use:

• Part 1: Extractables in aqueous autoclavates
• Part 2: Identification and characterization
• Part 3: Determination of released-particle count
• Part 4: Biological requirements and test methods
• Part 5: Functional requirements and testing

Introduction

The pharmaceutical industry requires, to an increasing extent, concrete details from the rubber manufacturer about the biological status of rubber closures as far as elastomeric closures are used as primary packaging materials in direct contact with the medicinal products. This request has been taken into account by preparing Annexes A to D of this part of ISO 8871.

Tests presented in this part of ISO 8871 can be taken into account as a guideline if the question of biological safety arises in context with primary packaging materials for pharmaceutical products. The use of certain tests of Annex A to Annex D in case of special applications of the packaging material should be agreed upon between users and manufacturers.

1 Scope

This part of ISO 8871 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

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.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

Bibliography