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

This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products. NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document. NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).

This document 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. This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

This document applies to anomaloscopes used to examine red-green-colour vision by investigating the colour match of a mixture of red and green compared with yellow, known as the “Rayleigh equation”. This document specifies the requirements for optical and technical parameters, which are of physiological relevance to ensure that the measured values on the eye of the examinee are independent of the technical characteristics of the anomaloscope used.

This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses. This document takes precedence over the corresponding requirements of other standards, if differences exist.

This document specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes. NOTE For the purpose of this document, optical radiation relates to the wavelength range of 250 nm to 2 500 nm. This document does not apply to therapeutic radiation. However, in the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target tissues, the limits given in this document may be applied to those parts of the treatment beam that strike non-target tissue. Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in ISO 15004-2, then those in the vertical International Standard take precedence. This document classifies ophthalmic instruments into either Group 1 or Group 2 to distinguish instruments that are non-hazardous from those that are potentially hazardous.

This document specifies a test method to be used in evaluating the antimicrobial activity of products for contact lens disinfection by chemical methods using the trophozoite form of Acanthamoeba species as the challenge organism. This document is not applicable to the evaluation of oxidative systems that require a special lens case for use.

This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer. This document is applicable to: — all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames; — spectacle frames made with additive manufacturing, for example, 3D printing; — spectacle frames made from natural organic materials; — the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply; — prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask. Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1. NOTE See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames. This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.

This document 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. This document specifies characteristics and minimum requirements for OCT instruments and systems. It specifies type tests and procedures to verify that a system or instrument qualifies as an OCT instrument or system in accordance with this document. NOTE In this document the term OCT refers to ophthalmic applications.

This document describes the methods currently used in applying tolerances to the focal powers of spectacle lenses and methods that can be considered for adoption in the future; it also describes methods of measuring the prism imbalance (relative prism error) between the lenses of a mounted pair. The results of a 2014 survey of manufacturing capability for lens power and a 2018 international web survey are discussed, as are possible new methods for applying tolerances to the focal power of spectacle lenses.

This document specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous vision, and/or accommodative optics. The generic descriptor ‘IOL’ used throughout this document also includes phakic intraocular lenses (PIOL).

This document is applicable to the three-dimensional aspects of spectacle lenses and their mounting in frames. It gives possible details of how these aspects can be taken into account, particularly for lenses with their permanent reference engravings (markings) on their back surface.

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.

This document applies to printed, projected, and electronic displays of high-contrast text that are designed for assessment and measurement of near reading acuity under photopic conditions. The definitions and requirements of this document apply to the Latin alphabet.

This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

This document specifies requirements for reference lenses for the calibration and verification of focimeters that are used for the measurement of spectacle form lenses, e.g. those complying with ISO 8598-1. It also gives a method for the determination of the back vertex power of the reference lenses. NOTE It is accepted that other reference lenses can also be used with powers within the given range, manufactured to the same standard of accuracy and form, but different back vertex powers. However, only lenses with integer nominal powers, as described in 4.1, can be used for the calibration of digitally-rounding focimeters.

This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus. This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist. This document is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories. This document is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.

This document specifies requirements for the transmittance properties of uncut and unmounted finished spectacle lenses, including attenuation of solar radiation. This document is not applicable to — spectacle lenses having specific transmittance or absorption characteristics prescribed for medical reasons, — products to which specific personal protective equipment transmittance standards apply, and — products intended for direct observation of the sun, such as for solar-eclipse viewing. NOTE 1 By reference to ISO 21987 and ISO 14889, this document also applies to lenses mounted in spectacles. NOTE 2 Optical and geometric requirements are given for uncut finished spectacle lenses in ISO 8980‑1 and ISO 8980‑2, and for mounted lenses, in ISO 21987.

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 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 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 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 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 18369-3:2017 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 18369-1:2017 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 18369-2:2017 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 21987:2017 specifies requirements and test methods for mounted spectacle lenses relative to the prescription order.

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/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.