11.040.70 - Ophthalmic equipment
ICS 11.040.70 Details
Ophthalmic equipment
Augenmedizinische Gerate
Matériel ophtalmique
Oftalmološka oprema
General Information
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.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft22 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft11 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft22 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft26 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard26 pagesEnglish languagesale 15% off
- Standard27 pagesFrench languagesale 15% off
- Draft25 pagesEnglish languagesale 15% off
- Draft27 pagesFrench languagesale 15% off
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.
- Standard22 pagesEnglish languagesale 15% off
- Standard22 pagesFrench languagesale 15% off
- Draft22 pagesEnglish languagesale 15% off
- Draft22 pagesFrench languagesale 15% off
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.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment10 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard4 pagesEnglish languagesale 15% off
- Standard5 pagesFrench languagesale 15% off
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.
- Standard27 pagesEnglish languagesale 15% off
- Standard28 pagesFrench languagesale 15% off
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.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard16 pagesEnglish languagesale 15% off
- Standard16 pagesEnglish languagesale 15% off
- Standard18 pagesFrench languagesale 15% off
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.
- Standard16 pagesEnglish languagesale 15% off
- Standard16 pagesFrench languagesale 15% off
- Draft16 pagesEnglish languagesale 15% off
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.
- Standard7 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
2019-12-04 - not allocated for publication because of missing TC decision to skip FV.
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
2019-12-04 - not allocated for publication because of missing TC decision to skip FV.
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
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.
- Technical report19 pagesEnglish languagesale 15% off
- Technical report21 pagesFrench languagesale 15% off
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. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.
- Amendment14 pagesEnglish languagesale 10% offe-Library read for1 day
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. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.
- Amendment14 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard76 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard76 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard66 pagesEnglish languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
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.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard10 pagesEnglish languagesale 15% off
- Standard10 pagesFrench languagesale 15% off
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.
- Technical report27 pagesEnglish languagesale 15% off
- Technical report29 pagesFrench languagesale 15% off
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 the eye.
The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and
PTIOL designs.
This document addresses specific clinical requirements for phakic IOLs that are not addressed in the
other parts of ISO 11979.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
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 recommendations on the design of spectacle frames.
This International Standard is not applicable to complete custom-made spectacle frames or to products
designed specifically to provide personal eye protection.
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the particular requirements for the clinical investigations of intraocular lenses
that are implanted in the eye in order to correct aphakia.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard42 pagesEnglish languagesale 15% off
- Standard44 pagesFrench languagesale 15% off
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.
- Standard17 pagesEnglish languagesale 15% off
- Standard20 pagesFrench languagesale 15% off
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.
- Standard8 pagesEnglish languagesale 15% off
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.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and verification methods for the optical and geometrical
properties for uncut finished power-variation lenses.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
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 could compromise
disinfection performance. This document does not measure disinfection performance.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
2022-03-06-JO-waiting for assessment at PUB
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day