CEN/TC 170 - Ophthalmic optics

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 reference wavelengths to be used for the characterization of optical materials, optical systems and instruments, and ophthalmic lenses. It defines the associated principal refractive indices and principal dispersions, as well as the Abbe numbers with regard to these reference wavelengths and principal dispersions.

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 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.

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.

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

2019-12-04 - not allocated for publication because of missing TC decision to skip FV.

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.

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 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.

This European Standard specifies the reference method for the testing of spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg/cm2/week set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear spectacles, sunglasses and other items for eye and face protection.
NOTE   The reference method for articles apart from spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection is specified in EN 1811.

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 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.

2022-03-06-JO-waiting for assessment at PUB

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 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 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 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 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 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 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 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 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 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 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 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.