ISO 11986:2017 眼科用光学系—コンタクトレンズおよびコンタクトレンズケア製品—防腐剤の取り込みと放出の測定 | 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, Part 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, Part 2 (see www.iso.org/directives ).

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This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.

This third edition cancels and replaces the second edition (ISO 11986:2010), which has been technically revised.

The main changes compared to the previous edition are as follows:

• the cross references were aligned with the revised editions of ISO 18369-1 and ISO 18369-3;
• the expression of results in the test report has been clarified;
• editorial corrections have been applied.

Introduction

Contact lens care products are a complex mixture of organic and inorganic substances. For reasons of microbiological safety, contact lens disinfecting solutions, as well as care products in multi-use containers, contain substances with antimicrobial activity. From many years of experience in contact lens wear, it is known that irritation and sensitization problems sometimes occur due to these preservatives being absorbed and released by the matrix of the contact lens. For these reasons, it is necessary to be able to estimate the extent of preservative uptake and release by contact lenses.

The preservative uptake and release test provides a general method for measuring the uptake of preservatives in solution by contact lenses and the release of preservatives from contact lenses in an aqueous medium. The analytical method to be used for quantification of specific preservatives is not indicated here. Chemical characteristics of the preservative, as well as concentration in the contact lens care product and degree of uptake by the contact lens, can be taken into consideration in selecting an appropriate analytical method. Contact lens uptake and release data can be useful in characterizing the potential for a new or modified contact lens material to produce a toxic or irritating reaction in the eye from the uptake and binding or release of preservatives from currently marketed contact lens care products.

1 Scope

This document provides general procedures for the selection of methods, preparation of samples, and the conduct of testing for the uptake and release of preservatives from contact lenses.

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

No terms and definitions are listed in this document.

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

Bibliography