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.

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    • Standard
      14 pages
      English language
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      1 day

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.

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    • Standard
      36 pages
      English language
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    • Amendment
      10 pages
      English language
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      7 pages
      English language
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    • Standard
      4 pages
      English language
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    • Standard
      5 pages
      French language

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.

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    • Standard
      27 pages
      English language
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    • Standard
      28 pages
      French language

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.

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    • Standard
      23 pages
      English language
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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 th...view more

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    • Standard
      16 pages
      English language
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    • Standard
      16 pages
      English language
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    • Standard
      18 pages
      French language

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.

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    • Standard
      16 pages
      English language
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    • Standard
      16 pages
      French language
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    • Draft
      16 pages
      English language

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.

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    • Standard
      7 pages
      English language
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    • Standard
      7 pages
      French language
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    • Amendment
      7 pages
      English language
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    • Amendment
      4 pages
      English language
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    • Amendment
      7 pages
      English language
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      4 pages
      English language
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2019-12-04 - not allocated for publication because of missing TC decision to skip FV.

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    • Amendment
      7 pages
      English language
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      4 pages
      English language
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    • Standard
      1 page
      English language
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    • Standard
      1 page
      French language

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

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    • Amendment
      7 pages
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      4 pages
      English language
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    • Standard
      1 page
      English language
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    • Standard
      1 page
      French language

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.

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    • Technical report
      19 pages
      English language
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    • Technical report
      21 pages
      French language

IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. ...view more

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    • Amendment
      14 pages
      English language
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IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. ...view more

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      14 pages
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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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    • Standard
      76 pages
      English language
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      1 day

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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    • Standard
      76 pages
      English language
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      1 day

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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    • Standard
      66 pages
      English language
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    • Standard
      66 pages
      French language

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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    • Standard
      17 pages
      English language
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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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    • Standard
      17 pages
      English language
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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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    • Standard
      10 pages
      English language
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    • Standard
      10 pages
      French language

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 effe...view more

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    • Technical report
      27 pages
      English language
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    • Technical report
      29 pages
      French language

This document 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 th...
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    • Standard
      25 pages
      English language
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This document 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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    • Standard
      50 pages
      English language
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This International Standard 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, semirimless
mounts and folding spectacle frames. It is also applicable to spectacle frames made from natural
organic materials.
NOTE See Annex A for recommenda...
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      38 pages
      English language
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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 des...
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      38 pages
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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 ...
view more

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    • Standard
      25 pages
      English language
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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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    • Standard
      50 pages
      English language
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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 e...view more

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    • Standard
      17 pages
      English language
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    • Standard
      20 pages
      French language

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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    • Standard
      42 pages
      English language
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    • Standard
      44 pages
      French language

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 h...view more

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    • Standard
      8 pages
      English language

This document specifies requirements and verification methods for the optical and geometrical
properties for uncut finished power-variation lenses.

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    • Standard
      15 pages
      English language
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This document 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.
This document 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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    • Standard
      17 pages
      English language
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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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      17 pages
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This document 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 coul...
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      14 pages
      English language
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This document 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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    • Standard
      14 pages
      English language
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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...
view more

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    • Standard
      14 pages
      English language
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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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    • Standard
      14 pages
      English language
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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 c...view more

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    • Standard
      6 pages
      English language
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    • Standard
      6 pages
      French language

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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    • Standard
      7 pages
      English language
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    • Standard
      8 pages
      French language

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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    • Standard
      10 pages
      English language
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    • Standard
      11 pages
      French language

2017-09-13 - CEN/BT C127/2017 - BT approved new Annex ZA and European Foreword - CCMC to publish

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      11 pages
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      1 page
      English language
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      1 page
      French language