ISO/TC 172/SC 7/WG 9 - Contact lenses

ISO 19979:2018 provides guidance to manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial hydrogel, composite and rigid gas-permeable (RGP) contact lenses intended for multipatient use. ISO 19979:2018 does not apply to: - labelling of contact lenses; - the inactivation of prions and viruses since there are no standardised methods available for contact lenses. ISO 19979:2018 can be used as guidance for the development of a hygienic management procedure for multipatient use. NOTE ISO 14729 does not cover multipatient use.

ISO 11986:2017 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. NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses. NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This document does not measure disinfection performance.

ISO 11981:2017 describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible.

ISO 18369-2:2017 specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture. These tolerances might not apply to other purposes, for example, shelf-life studies.

ISO 18369-4:2017 specifies the methods of testing the physicochemical properties of contact lens materials. These are extraction, rigid lens flexure and breakage, oxygen permeability, refractive index and water content.

ISO 18369-3:2017 specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369‑2, i.e. radius of curvature, label back vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections and determination of spectral transmittance. This document also specifies the equilibrating solution and standard saline solution for testing of contact lenses.

ISO 18369-1:2017 identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. This document also defines the terms relating to contact lens care products. It also incorporates the classifications of contact lens materials and gives recommendations for the labelling of the specifications of contact lenses.

ISO 11978:2017 specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer. ISO 11978:2017 does not specify the format in which such information shall be provided.

Iso 18189:2016 describes an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions. NOTE The potential of a contact lens or a contact lens care solution to cause cytotoxicity by itself can be evaluated in accordance with general guidance in ISO 10993‑5.

ISO 19045:2015 specifies a method for evaluating the potential of products for contact lens disinfection to induce encystment of Acanthamoeba species. This method excludes the evaluation of oxidative systems that require a special lens case for use. This International Standard does not address the evaluation of disinfection efficacy of contact lens disinfecting products.

ISO 14730:2014 specifies a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact lens care products, and provides guidance on methods to be used for determination of discard date as informative annexes.

ISO 18259:2014 specifies an antimicrobial efficacy end point methodology to determine compatibility of contact lens solutions, lens cases and hydrogel lenses for disinfection. This provides a process for evaluating compatibility of solutions used for disinfection with contact lenses and lens cases using an antimicrobial efficacy end point. Specifically, the microbiological effect of the antimicrobial agent(s) while in the presence of the lens cases and/or lenses will be evaluated as described in the soak step of the label instructions.

ISO 13212:2014 provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products.

ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.

ISO 9394:2012 specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in application to rabbit eyes.

ISO 11987:2012 specifies test procedures for determining the stability of contact lenses once placed in their final packaging during storage and distribution.

ISO 14534:2011 specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. ISO 14534:2011 does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products.

ISO/TS 19979:2014 provides guidance to contact lens manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial soft and rigid gas-permeable (RGP) contact lenses intended for multipatient use.

ISO 11978:2014 specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of users of contact lenses: the eye care professional and the contact lens wearer.

ISO 18369-2:2012 specifies the tolerance limits of the principal optical and physical parameters of rigid, soft and rigid scleral contact lenses.

ISO 11986:2010 provides general procedures for the selection of methods, preparation of samples, and conduct of testing for the uptake and release of preservatives from contact lenses.

ISO 11980:2009 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.

ISO 11981:2009 describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible.

ISO 18369-3:2006 specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369-2, i.e. radius of curvature, back vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections, and determination of spectral and luminous transmittances. ISO 18369-3:2006 also specifies the equilibrating solution, standard saline solution, for testing of contact lenses.

ISO 18369-4:2006 specifies the methods of testing the physicochemical properties of contact lens materials. These are extraction, rigid lens flexure and breakage, oxygen permeability, refractive index and water content.

ISO 18369-2:2006 specifies the tolerance limits of the principal optical and physical parameters of rigid, soft, and rigid scleral contact lenses.

ISO 18369-1:2006 identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. ISO 18369-1:2006 also defines the terms relating to contact lens care products. It also incorporates the classifications of contact lens materials and gives recommendations for the labelling of the specifications of contact lenses.

ISO 9337-2:2004 describes test methods for the determination of back vertex power of soft contact lenses immersed in saline. It is applicable to finished contact lenses.

ISO/TS 19979:2004 provides guidance to contact lens manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial soft and rigid gas-permeable (RGP) contact lenses intended for multipatient use.

ISO 8320-1:2003 identifies and defines terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms that have been used in the text of other International Standards that were developed for or are applicable to contact lenses.

Specifies two in vitro methods for determining the cytotoxicity of contact lens materials: the agar overlay test and the growth inhibition test. Primary purpose of these tests is to reveal the presence of leachable cytotoxic substances in or on contact lenses.