11.040.70 - Ophthalmic equipment
Ophthalmic equipment
Augenmedizinische Gerate
Matériel ophtalmique
Oftalmološka oprema
General Information
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 language
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- Draft13 pagesEnglish language
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- Amendment10 pagesEnglish language
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- Amendment7 pagesEnglish language
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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 language
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- Draft33 pagesEnglish language
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- Standard5 pagesFrench language
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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.
- Standard28 pagesFrench language
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sale 15% off- Draft29 pagesFrench language
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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 language
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- Draft19 pagesEnglish 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
- Standard16 pagesEnglish language
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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 language
sale 15% off- Standard16 pagesFrench language
sale 15% off- Draft16 pagesEnglish language
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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 pagesFrench language
sale 15% off- Standard7 pagesEnglish language
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- Amendment7 pagesEnglish language
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- Amendment4 pagesEnglish language
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- Amendment7 pagesEnglish language
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- Amendment4 pagesEnglish language
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2019-12-04 - not allocated for publication because of missing TC decision to skip FV.
- Amendment7 pagesEnglish language
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- Amendment4 pagesEnglish language
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- Standard1 pageFrench language
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2019-12-04 - not allocated for publication because of missing TC decision to skip FV.
- Amendment7 pagesEnglish language
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- Amendment4 pagesEnglish language
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- Standard1 pageFrench language
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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 report21 pagesFrench 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
- Amendment14 pagesEnglish 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
- Amendment14 pagesEnglish language
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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.
- Standard76 pagesEnglish language
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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.
- Standard76 pagesEnglish language
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