| Name |
Description |
Abstract |
Status |
Publication date |
Edition |
Number of pages |
Technical committee |
ICS |
| ISO 11979-7:2018 |
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
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.
|
Published |
2018-03 |
Edition : 4 |
Number of pages : 42 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO/DIS 11979-7 |
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
|
Under development |
|
Edition : 5 |
Number of pages : 51 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-8:1999 |
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
|
Withdrawn |
1999-08 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-8:1999/Cor 1:2003 |
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements — Technical Corrigendum 1 |
|
Withdrawn |
2003-11 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15798:2001/Cor 1:2003 |
Ophthalmic implants — Ophthalmic viscosurgical devices — Technical Corrigendum 1 |
|
Withdrawn |
2003-11 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-8:2006 |
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
11979-8:2006 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.
|
Withdrawn |
2006-07 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-8:2006/Amd 1:2011 |
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements — Amendment 1 |
|
Withdrawn |
2011-05 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-8:2017 |
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
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.
|
Published |
2017-04 |
Edition : 3 |
Number of pages : 4 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-9:2006 |
Ophthalmic implants — Intraocular lenses — Part 9: Multifocal intraocular lenses |
ISO 11979-9:2006 is applicable to any intraocular lens whose optic provides two or more rotationally symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).
The term "near vision" as used in ISO 11979-9:2006 includes useful vision at a distance of claimed benefit; e.g. near and/or intermediate distances.
|
Withdrawn |
2006-09 |
Edition : 1 |
Number of pages : 20 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-9:2006/Amd 1:2014 |
Ophthalmic implants — Intraocular lenses — Part 9: Multifocal intraocular lenses — Amendment 1 |
|
Withdrawn |
2014-08 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-10:2006 |
Ophthalmic implants — Intraocular lenses — Part 10: Phakic intraocular lenses |
ISO 11979-10:2006 is applicable to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye but excludes phakic IOLs (PIOLs) that utilize multifocal or other simultaneous vision optics to address presbyopic loss of accommodation and PIOLs that correct astigmatism.
ISO 11979-10:2006 addresses specific requirements for PIOLs not addressed in the other parts of ISO 11979.
|
Withdrawn |
2006-08 |
Edition : 1 |
Number of pages : 18 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-10:2006/Amd 1:2014 |
Ophthalmic implants — Intraocular lenses — Part 10: Phakic intraocular lenses — Amendment 1 |
|
Withdrawn |
2014-08 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11979-10:2018 |
Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes |
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.
|
Published |
2018-03 |
Edition : 2 |
Number of pages : 17 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11980:1997 |
Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations |
|
Withdrawn |
1997-12 |
Edition : 1 |
Number of pages : 18 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11980:1997/Cor 1:1998 |
Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations — Technical Corrigendum 1 |
|
Withdrawn |
1998-04 |
Edition : 1 |
|
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11980:2009 |
Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations |
ISO 11980:2009 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.
|
Withdrawn |
2009-10 |
Edition : 2 |
Number of pages : 28 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11980:2012 |
Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations |
ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.
|
Published |
2012-11 |
Edition : 3 |
Number of pages : 26 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11981:1999 |
Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses |
|
Withdrawn |
1999-06 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11981:2009 |
Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses |
ISO 11981:2009 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.
|
Withdrawn |
2009-07 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11981:2017 |
Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses |
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.
|
Published |
2017-11 |
Edition : 3 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11984:1999 |
Ophthalmic optics — Contact lenses — Determination of rigid lens flexure and breakage |
|
Withdrawn |
1999-12 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11985:1997 |
Ophthalmic optics — Contact lenses — Ageing by exposure to UV and visible radiation (in vitro method) |
|
Withdrawn |
1997-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11986:1999 |
Ophthalmic optics — Contact lenses and contact lens care products — Guidelines for determination of preservative uptake and release |
|
Withdrawn |
1999-05 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11986:2010 |
Ophthalmic optics — Contact lenses and contact lens care products — Determination of preservative uptake and release |
ISO 11986:2010 provides general procedures for the selection of methods, preparation of samples, and conduct of testing for the uptake and release of preservatives from contact lenses.
|
Withdrawn |
2010-11 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11986:2017 |
Ophthalmic optics — Contact lenses and contact lens care products — Determination of preservative uptake and release |
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.
|
Published |
2017-11 |
Edition : 3 |
Number of pages : 6 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11987:1997 |
Ophtalmic optics — Contact lenses — Determination of shelf-life |
|
Withdrawn |
1997-11 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11987:1997/Cor 1:1998 |
Ophtalmic optics — Contact lenses — Determination of shelf-life — Technical Corrigendum 1 |
|
Withdrawn |
1998-04 |
Edition : 1 |
|
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 11987:2012 |
Ophthalmic optics — Contact lenses — Determination of shelf-life |
ISO 11987:2012 specifies test procedures for determining the stability of contact lenses once placed in their final packaging during storage and distribution.
|
Published |
2012-07 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12864:1997 |
Ophthalmic optics — Contact lenses — Determination of scattered light |
|
Withdrawn |
1997-12 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12865:1998 |
Ophthalmic instruments — Retinoscopes |
|
Withdrawn |
1998-06 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12865:2006 |
Ophthalmic instruments — Retinoscopes |
ISO 12865:2006, together with ISO 15004-1, specifies minimum requirements and test methods for hand-held streak and spot retinoscopes for use in objective determination of the refractive errors of the eye.
ISO 12865:2006 takes precedence over ISO 15004-1, if differences exist.
|
Published |
2006-07 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12866:1999 |
Ophthalmic instruments — Perimeters |
|
Published |
1999-06 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12866:1999/Amd 1:2008 |
Ophthalmic instruments — Perimeters — Amendment 1 |
|
Published |
2008-11 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12867:2010 |
Ophthalmic instruments — Trial frames |
ISO 12867:2010, together with ISO 15004‑1, specifies minimum requirements and test methods for trial frames for holding trial case lenses, complying with ISO 9801, in front of a subject's eyes in order to assess visual acuity and facilitate optical correction of vision.
ISO 12867:2010 is applicable to lens holders mounted on headbands, bracket-mounted frames and frames mounted in the manner of spectacles with supports on the ears and the bridge of the nose. It is applicable to all types of trial frame, including half-eye and rotating lens holders.
ISO 12867:2010 takes precedence over ISO 15004‑1, if differences exist.
|
Published |
2010-06 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12870:1997 |
Ophthalmic optics — Spectacle frames — General requirements and test methods |
|
Withdrawn |
1997-12 |
Edition : 1 |
Number of pages : 16 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12870:2004 |
Ophthalmic optics — Spectacle frames — Requirements and test methods |
ISO 12870:2004 specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses, and is applicable to frames at the point of sale to the retailer, by the manufacturer or supplier.
It is applicable to all spectacle frame types including rimless mounts, semi-rimless mounts and folding spectacle frames. ISO 12870:2004 is applicable to spectacle frames made from natural organic materials.
It is not applicable to complete custom-made spectacle frames or to products designed specifically to provide personal eye protection.
|
Withdrawn |
2004-08 |
Edition : 2 |
Number of pages : 26 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12870:2012 |
Ophthalmic optics — Spectacle frames — Requirements and test methods |
|
Withdrawn |
2012-04 |
Edition : 3 |
Number of pages : 28 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 12870:2016 |
Ophthalmic optics — Spectacle frames — Requirements and test methods |
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.
|
Published |
2016-11 |
Edition : 4 |
Number of pages : 26 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO/FDIS 12870 |
Ophthalmic optics — Spectacle frames — Requirements and test methods |
|
Under development |
|
Edition : 5 |
|
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 13212:1999 |
Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life |
|
Withdrawn |
1999-05 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 13212:2011 |
Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life |
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.
|
Withdrawn |
2011-05 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 13212:2014 |
Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life |
ISO 13212:2014 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.
|
Published |
2014-09 |
Edition : 3 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 13230:1999 |
Ophthalmic optics — Bar code specifications |
|
Withdrawn |
1999-03 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.70
Ophthalmic equipment
;
35.040.50
Automatic identification and data capture techniques
|
| ISO 13666:1998 |
Ophthalmic optics — Spectacle lenses — Vocabulary |
|
Withdrawn |
1998-08 |
Edition : 1 |
Number of pages : 59 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.70
Ophthalmic equipment
|
| ISO 13666:2012 |
Ophthalmic optics — Spectacle lenses — Vocabulary |
ISO 13666:2011 defines basic terms relating to ophthalmic optics, specifically to semi-finished spectacle lens blanks, finished spectacle lenses and fitting purposes.
Terms relating to processes and materials 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.
|
Withdrawn |
2012-11 |
Edition : 2 |
Number of pages : 167 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.70
Ophthalmic equipment
|
| ISO 13666:2019 |
Ophthalmic optics — Spectacle lenses — Vocabulary |
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.
|
Published |
2019-02 |
Edition : 3 |
Number of pages : 66 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.70
Ophthalmic equipment
|
| ISO 14534:1997 |
Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements |
|
Withdrawn |
1997-12 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14534:1997/Cor 1:1998 |
Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements — Technical Corrigendum 1 |
|
Withdrawn |
1998-04 |
Edition : 1 |
|
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14534:2002 |
Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements |
This International Standard specifies safety and performance requirements for contact lenses, contact lens care products and other accessories for contact lenses.
This International Standard does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses and/or contact lens care products.
|
Withdrawn |
2002-06 |
Edition : 2 |
Number of pages : 11 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14534:2011 |
Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements |
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.
|
Published |
2011-04 |
Edition : 3 |
Number of pages : 10 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14729:2001 |
Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses |
|
Published |
2001-04 |
Edition : 1 |
Number of pages : 21 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14729:2001/Amd 1:2010 |
Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses — Amendment 1 |
|
Published |
2010-10 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14730:2000 |
Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date |
|
Withdrawn |
2000-09 |
Edition : 1 |
Number of pages : 23 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14730:2014 |
Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date |
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.
|
Published |
2014-10 |
Edition : 2 |
Number of pages : 23 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14889:1997 |
Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses |
|
Withdrawn |
1997-07 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14889:2003 |
Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses |
ISO 14889:2002 specifies fundamental requirements for uncut finished spectacle lenses. This International Standard is not applicable to protective spectacle lenses.
ISO 14889:2002 takes precedence over the corresponding requirements of other standards, if differences exist.
|
Withdrawn |
2003-05 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14889:2013 |
Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses |
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.
|
Published |
2013-10 |
Edition : 3 |
Number of pages : 6 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 14889:2013/Amd 1:2017 |
Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses — Amendment 1 |
|
Published |
2017-10 |
Edition : 3 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15004-1:2006 |
Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments |
ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
|
Withdrawn |
2006-06 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15004-1:2020 |
Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments |
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.
|
Published |
2020-05 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15004-2:2007 |
Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection |
ISO 15004-2:2007 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 and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.
ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.
ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.
|
Published |
2007-02 |
Edition : 1 |
Number of pages : 37 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO/CD 15004-2.2 |
Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection |
|
Under development |
|
Edition : 2 |
|
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15004:1997 |
Ophthalmic instruments — Fundamental requirements and test methods |
|
Withdrawn |
1997-12 |
Edition : 1 |
Number of pages : 15 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15253:2000 |
Ophthalmic optics and instruments — Optical devices for enhancing low vision |
|
Withdrawn |
2000-09 |
Edition : 1 |
Number of pages : 21 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15253:2021 |
Ophthalmic optics and instruments — Optical and electro-optical devices for enhancing low vision |
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.
|
Published |
2021-06 |
Edition : 2 |
Number of pages : 26 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15254:2002 |
Ophthalmic optics and instruments — Electro-optical devices for enhancing low vision |
This International Standard applies to electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision aids.
It specifies electro-optical and mechanical requirements and test methods. It does not cover optical devices for enhancing low vision which are specified in ISO 15253.
|
Withdrawn |
2002-08 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15254:2009 |
Ophthalmic optics and instruments — Electro-optical devices for enhancing low vision |
ISO 15254:2009 applies to electro-optical devices specified by the manufacturer for use by visually impaired persons, as low-vision aids.
It specifies electro-optical and mechanical requirements and test methods.
|
Withdrawn |
2009-07 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15752:2000 |
Ophthalmic instruments — Endoilluminators — Fundamental requirements and test methods for optical radiation safety |
|
Withdrawn |
2000-12 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15752:2010 |
Ophthalmic instruments — Endoilluminators — Fundamental requirements and test methods for optical radiation safety |
ISO 15752:2010 specifies optical radiation safety aspects of endoilluminator light sources and endoilluminator light guides which are used to illuminate the interior of the eye during ocular surgery.
|
Published |
2010-01 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15798:2001 |
Ophthalmic implants — Ophthalmic viscosurgical devices |
|
Withdrawn |
2001-06 |
Edition : 1 |
Number of pages : 20 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15798:2010 |
Ophthalmic implants — Ophthalmic viscosurgical devices |
ISO 15798:2010 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants 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 intra-ocular tissues and to manipulate tissues during surgery.
ISO 15798:2010 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.
|
Withdrawn |
2010-02 |
Edition : 2 |
Number of pages : 16 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15798:2013 |
Ophthalmic implants — Ophthalmic viscosurgical devices |
ISO 15798:2013 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants 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 intra-ocular tissues and to manipulate tissues during surgery.
ISO 15798:2013 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.
|
Withdrawn |
2013-09 |
Edition : 3 |
Number of pages : 16 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15798:2013/Amd 1:2017 |
Ophthalmic implants — Ophthalmic viscosurgical devices — Amendment 1 |
|
Withdrawn |
2017-05 |
Edition : 3 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 15798:2022 |
Ophthalmic implants — Ophthalmic viscosurgical devices |
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.
|
Published |
2022-01 |
Edition : 4 |
Number of pages : 19 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16034:2002 |
Ophthalmic optics — Specifications for single-vision ready-to-wear near- vision spectacles |
This International Standard specifies the minimum requirements for complete single-vision ready-to-wear near-vision spectacles. These spectacles are not intended for regular use without the approval of an eyecare professional.
|
Published |
2002-02 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16034:2002/Cor 1:2006 |
Ophthalmic optics — Specifications for single-vision ready-to-wear near- vision spectacles — Technical Corrigendum 1 |
|
Published |
2006-08 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16284:2001 |
Ophthalmic optics — Information interchange for ophthalmic optical equipment |
|
Withdrawn |
2001-06 |
Edition : 1 |
Number of pages : 61 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16284:2006 |
Ophthalmic optics — Information interchange for ophthalmic optical equipment |
ISO 16284:2006 establishes a method by which machines and computer software systems used in the fabrication of ophthalmic lenses can exchange information.
|
Withdrawn |
2006-03 |
Edition : 2 |
Number of pages : 70 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16671:2003 |
Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
ISO 16671:2002 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 16671:2002 applies to ophthalmic irrigating solutions (OISs), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological or metabolic function.
|
Withdrawn |
2003-05 |
Edition : 1 |
Number of pages : 21 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16671:2015 |
Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
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.
|
Published |
2015-08 |
Edition : 2 |
Number of pages : 22 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16671:2015/Amd 1:2017 |
Ophthalmic implants — Irrigating solutions for ophthalmic surgery — Amendment 1 |
|
Published |
2017-10 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 5662:1997 |
Petroleum products — Electrical insulating oils — Detection of corrosive sulfur |
|
Withdrawn |
1997-03 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
29.040.10
Insulating oils
|
| ISO/CD 16671 |
Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
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.
|
Under development |
|
Edition : 3 |
|
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16672:2003 |
Ophthalmic implants — Ocular endotamponades |
ISO 16672:2003 applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OEs, ISO 16672:2003 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.
|
Withdrawn |
2003-02 |
Edition : 1 |
Number of pages : 13 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16672:2015 |
Ophthalmic implants — Ocular endotamponades |
ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OE, this International Standard 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.
|
Withdrawn |
2015-08 |
Edition : 2 |
Number of pages : 13 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16672:2020 |
Ophthalmic implants — Ocular endotamponades |
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.
|
Published |
2020-06 |
Edition : 3 |
Number of pages : 16 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO/CD 16971-1 |
Ophthalmic instruments — Optical coherence tomographs — Part 1: Optical coherence tomographs for the posterior segment of the human eye |
ISO 16971:2015 is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye.
ISO 16971:2015 defines certain terms that are specific to this diagnostic procedure.
ISO 16971:2015 specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with ISO 16971:2015 and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs.
|
Under development |
|
Edition : 1 |
|
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 16971:2015 |
Ophthalmic instruments — Optical coherence tomograph for the posterior segment of the human eye |
ISO 16971:2015 is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye.
ISO 16971:2015 defines certain terms that are specific to this diagnostic procedure.
ISO 16971:2015 specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with ISO 16971:2015 and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs.
|
Published |
2015-04 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18189:2016 |
Ophthalmic optics — Contact lenses and contact lens care products — Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions |
Iso 18189:2016 describes an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions.
NOTE The potential of a contact lens or a contact lens care solution to cause cytotoxicity by itself can be evaluated in accordance with general guidance in ISO 10993‑5.
|
Published |
2016-06 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18259:2014 |
Ophthalmic optics — Contact lens care products — Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms |
ISO 18259:2014 specifies an antimicrobial efficacy end point methodology to determine compatibility of contact lens solutions, lens cases and hydrogel lenses for disinfection. This provides a process for evaluating compatibility of solutions used for disinfection with contact lenses and lens cases using an antimicrobial efficacy end point. Specifically, the microbiological effect of the antimicrobial agent(s) while in the presence of the lens cases and/or lenses will be evaluated as described in the soak step of the label instructions.
|
Published |
2014-10 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18369-1:2006 |
Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications |
ISO 18369-1:2006 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. ISO 18369-1:2006 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.
|
Withdrawn |
2006-08 |
Edition : 1 |
Number of pages : 48 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.70
Ophthalmic equipment
|
| ISO 18369-1:2006/Amd 1:2009 |
Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications — Amendment 1 |
|
Withdrawn |
2009-02 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.70
Ophthalmic equipment
|
| ISO 18369-1:2017 |
Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications |
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.
|
Published |
2017-08 |
Edition : 2 |
Number of pages : 66 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.70
Ophthalmic equipment
|
| ISO 18369-2:2006 |
Ophthalmic optics — Contact lenses — Part 2: Tolerances |
ISO 18369-2:2006 specifies the tolerance limits of the principal optical and physical parameters of rigid, soft, and rigid scleral contact lenses.
|
Withdrawn |
2006-08 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18369-2:2012 |
Ophthalmic optics — Contact lenses — Part 2: Tolerances |
ISO 18369-2:2012 specifies the tolerance limits of the principal optical and physical parameters of rigid, soft and rigid scleral contact lenses.
|
Withdrawn |
2012-12 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18369-2:2017 |
Ophthalmic optics — Contact lenses — Part 2: Tolerances |
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.
|
Published |
2017-08 |
Edition : 3 |
Number of pages : 7 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18369-3:2006 |
Ophthalmic optics — Contact lenses — Part 3: Measurement methods |
ISO 18369-3:2006 specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369-2, i.e. radius of curvature, back vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections, and determination of spectral and luminous transmittances. ISO 18369-3:2006 also specifies the equilibrating solution, standard saline solution, for testing of contact lenses.
|
Withdrawn |
2006-08 |
Edition : 1 |
Number of pages : 37 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18369-3:2017 |
Ophthalmic optics — Contact lenses — Part 3: Measurement methods |
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.
|
Published |
2017-08 |
Edition : 2 |
Number of pages : 40 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18369-4:2006 |
Ophthalmic optics — Contact lenses — Part 4: Physicochemical properties of contact lens materials |
ISO 18369-4:2006 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.
|
Withdrawn |
2006-08 |
Edition : 1 |
Number of pages : 30 |
Technical Committee |
11.040.70
Ophthalmic equipment
|
| ISO 18369-4:2017 |
Ophthalmic optics — Contact lenses — Part 4: Physicochemical properties of contact lens materials |
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.
|
Published |
2017-08 |
Edition : 2 |
Number of pages : 36 |
Technical Committee |
11.040.70
Ophthalmic equipment
|