ISO/TC 172/SC 7/WG 6 - Ophthalmic instruments and test methods

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. NOTEÂ Â Â Â Â 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 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.

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 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 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/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 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 10343:2014 specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer have sufficient resolution and range to adequately measure the radii of curvature of contact lenses. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal.

ISO 22665:2012 is applicable to instruments and methods used for measuring the axial length of the human eye. It defines minimum requirements for such instruments and systems and defines test methods and procedures to verify that a system or instrument qualifies as an axial length measuring device.

ISO 10341:2012 specifies requirements and test methods for refractor heads used for the determination of refractive errors and binocular functions of the human eye.

This International Standard 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 International Standard and thus qualifies as a CT according to this International Standard. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This International Standard 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 International Standard 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. It is not applicable to ophthalmic instruments classified as ophthalmometers.

ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.