ISO/TC 172/SC 7 - Ophthalmic optics and instruments

This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery. This document specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus. This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

This document is applicable to optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision aids. This document specifies requirements and test methods for optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision devices. Implantable low vision devices are excluded.

This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. This document is not applicable to ophthalmic instruments classified as ophthalmometers.

This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina. With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

This document specifies a measuring system for spectacle frames and related vocabulary. It is applicable to spectacle frames with fronts that are intended to be symmetrical.

This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

This document describes the most commonly used test methods considered in standardization work relating to scratch and abrasion resistance of plastic spectacle lenses along with their technical capacities and limitations. It includes the ISO test method for assessment of claims for basic abrasion resistance in ISO 8980-5. This document is intended to be of benefit to any future interest in ISO standardization on scratch and abrasion resistance of spectacle lenses.

This document defines terms relating to ophthalmic optics, specifically to blanks, finished spectacle lenses and fitting purposes. Terms relating to processes and material for fabrication and surface treatment (other than some specific terms relating to coatings), and terms relating to defects in materials and after optical processing are given in ISO 9802.

This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them. NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document.

This document describes visible solar radiation with wavelengths close to the UV range, its transmission to, within and the effects on the human eye. The wavelengths concerned are from 380 nm to 500 nm, covering the colours of violet, indigo and blue — often referred to as the "blue wavelengths". It also explains the filtering effects and measurement of spectacle lenses and sunglasses, thereby providing background information to understand the transmittance requirements related to filtering effects of lenses and filters in the available spectacle lens and sunglass standards. This document does not address the issues of protection from artificial sources of radiation. This document is intended to be of benefit to any future interest in ISO standardization related to transmission of solar radiation with wavelengths near to and greater than 380 nm. The Bibliography provides a source of relevant useful references.

ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main categories of phakic intraocular lenses depending on the optical design: a) Phakic monofocal (PIOL); b) Phakic multifocal (PMIOL); and c) Phakic toric (PTIOL). Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye. The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs. ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.

ISO 11979-7:2018 specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

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 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 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 8596:2017 specifies a range of Landolt ring optotypes and describes a method for measuring distance visual acuity under photopic conditions for the purposes of certification or licensing. ISO 8596:2017 is neither intended as a standard for clinical measurements nor for the certification of blindness or partial sight. Other optotypes used for clinical investigations are described in Annex A for information.

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 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 18369-4:2017 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 18369-2:2017 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 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 8980-1:2017 specifies requirements and verification methods for the optical and geometrical properties for uncut finished single-vision and multifocal spectacle lenses.

ISO 8980-2:2017 specifies requirements and verification methods for the optical and geometrical properties for uncut finished power-variation lenses.

ISO 21987:2017 specifies requirements and test methods for mounted spectacle lenses relative to the prescription order.

ISO/TR 18476:2017 outlines all the steps from refraction to dispensing of spectacles, with particular attention to the benefits added by using free form technology, and provides a collection of relevant terms and descriptions. ISO/TR 18476:2017 does not contain the proprietary features of lens designs provided by suppliers.

ISO 10939:2017, together with ISO 15004‑1 and ISO 15004‑2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic equipment and lasers. ISO 10939:2017 takes precedence over ISO 15004‑1 and ISO 15004‑2, if differences exist.

ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.

ISO 11979-8:2017 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

ISO 12870:2016 specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses. It is applicable to frames at the point of sale by the manufacturer or supplier to the retailer. This International Standard is applicable to all spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames. It is also applicable to spectacle frames made from natural organic materials. NOTE See Annex A for recommendations on the design of spectacle frames. ISO 12870:2016 is not applicable to complete custom-made spectacle frames or to products designed specifically to provide personal eye protection.

ISO 11381:2016 specifies requirements for ISO metric screw threads for use with spectacle frames. Provision is made for screw threads of the following nominal sizes: S0,8 × 0,2; M1,0 × 0,25; M1,2 × 0,25; M1,4 × 0,3; M1,6 × 0,35 and M2,0 × 0,4 and for related taps and gauges.

ISO 10938:2016 applies to displays of optotypes generated by chart projectors and all other visual acuity measurement systems that use recognition of high-contrast optotypes and that are designed for general use, including optotypes printed on media (either opaque or intended for transillumination), those generated electronically, and those produced by optical projection.

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 10685-2:2016 specifies the commercial information and file format used for trading spectacle frames and sunglasses. ISO 10685-2:2016 includes sunglass clip-ons.

ISO 10322-1:2016 specifies requirements for the optical and geometrical properties of all semi-finished single-vision and multifocal spectacle lens blanks.

ISO 10322-2:2016 specifies requirements for the optical and geometrical properties of semi-finished lens blanks with finished progressive-power and degressive-power surfaces.

ISO/TR 19498:2015 specifies a method of correlation between a given set of optotypes and the standard optotype (Landolt ring) formed and presented as specified in ISO 8596. All test methods are type tests and suitable equivalent test methods may be substituted.

ISO 16671:2015 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

ISO 16971:2015 is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye. ISO 16971:2015 defines certain terms that are specific to this diagnostic procedure. ISO 16971:2015 specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with ISO 16971:2015 and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs.

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 11979-6:2014 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.

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 8598-1:2014 specifies requirements and test methods for general purpose focimeters designed for the measurement of vertex powers, cylinder axis, prismatic power and prism base setting within a restricted area at a specified location of a lens. This excludes instruments that can only measure the whole lens at once. It is applicable to instruments typically intended for use by the ophthalmic community, with the capability to demonstrate conformity of spectacle lens products with the International Standards existing for these lenses.