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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

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

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

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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.

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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.

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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.

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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.

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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.

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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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ISO 13212:2011 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 13212:2011does not address studies designed to obtain information to establish the in-use stability (i.e. notice of discard date) of contact lens care products.

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ISO 11979-2:2014 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor ?IOL' used throughout ISO 11979-2:2014 also includes phakic intraocular lenses (PIOL).

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ISO 10343:2009, together with ISO 15004-1, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer are capable of measuring radii of curvature of contact lenses as described in ISO 18369-3:2006, 4.1. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal.
ISO 10343:2009 takes priority over ISO 15004-1, if differences exist.

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ISO 14889:2013 specifies fundamental requirements for uncut finished spectacle lenses. It is not applicable to protective spectacle lenses.
ISO 14889:2013 takes precedence over the corresponding requirements of other standards, if differences exist.

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ISO 8980-1:2013 specifies requirements for the transmittance properties of uncut finished spectacle lenses and mounted pairs, including attenuation of solar radiation.

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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.

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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.

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2011-06-01 EMA: Draft for // Enquiry received in ISO/TC (see notification of 2011-05-31 in dataservice)

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

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2012-04-19 EMA: Draft for // vote received in ISO/CS (see notification of 2012-04-16 in dataservice).
2011-05-26 EMA: draft for // ENQ received in ISO/CS (see notification of 2011-05-25 in dataservice).

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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.

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2012-03-28 EMA: Draft for // vote received in ISO/CS (see notification of 2012-03-27 in dataservice).
2011-05-31 EMA: Draft for // ENQ received in ISO/CS (see notification of 2011-05-30 in dataservice).

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

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ISO 10685-1:2011 establishes rules and requirements for the definition of a unique identifier for spectacle frames and sunglass frames, and specifies the data information and file format used for identifying spectacle frames and sunglass frames.
It is applicable to sunglass clip-ons.

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ISO 10943:2011 specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
ISO 10943:2011 is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
ISO 10943:2011 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.

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Amandma A1:2010 je dodatek k standardu SIST EN ISO 14729:2002
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. This International Standard is not applicable to the hygienic management of trial lenses.

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This European Standard specifies the minimum requirements for complete ready-to-wear spectacles. These are not intended for regular use without the approval of an eye-care professional.

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