National foreword

This British Standard is the UK implementation of EN ISO 11987:2012. It supersedes BS EN ISO 11987:1998 which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/172/9, Contact lenses and contact lens care products.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2012.

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 11987 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.

This second edition cancels and replaces the first edition (ISO 11987:1997), which has been technically revised. It also incorporates the Technical Corrigendum ISO 11987:1997/Cor.1:1998.

Introduction

The tests included in this International Standard are designed to obtain information that enables proposals to be made for the shelf-life of a contact lens, and storage conditions to be recommended. However, in practical terms, it is the stability of the material from which the contact lens is made that is being tested, along with the integrity of the packaging that maintains the environment necessary for the contact lens.

The purpose of the stability studies is to ascertain how the quality of the contact lens varies as a function of time and under the influence of a variety of environmental factors. On the basis of the information thus obtained, storage conditions can be recommended that guarantee the maintenance of the quality of the contact lens in relation to its safety, efficacy and acceptability throughout the proposed shelf-life (i.e. during storage and distribution until the moment of dispensing).

This European Standard was approved by CEN on 14 July 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Foreword

This document (EN ISO 11987:2012) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 11987:1997.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 11987:2012 has been approved by CEN as a EN ISO 11987:2012 without any modification.

1 Scope

This International Standard specifies test procedures for determining the stability of contact lenses once they are placed in their final packaging during storage and distribution.

NOTE The results obtained can be used for determining the expiry date.

2 Normative references

3 Terms and definitions

4 Principle

5 General requirements and recommendations

6 Test and measurement media

6.1

6.2

7 Apparatus

7.1

7.2

7.3

8 Test samples

8.1

8.2

8.3

8.4

9 Test procedure

9.1 Real-time studies

9.2 Accelerated ageing studies

10 Expression of results

11 Test report

Bibliography

BS EN ISO 11987:2012

Ophthalmic optics. Contact lenses. Determination of shelf-life

Current, Under Review

Published:

31 Jul 2012