11.040.70 - Ophthalmic equipment
ICS 11.040.70 Details
Ophthalmic equipment
Augenmedizinische Gerate
Matériel ophtalmique
Oftalmološka oprema
General Information
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This document is applicable to the three-dimensional aspects of spectacle lenses and their mounting in frames. It gives possible details of how these aspects can be taken into account, particularly for lenses with their permanent reference engravings (markings) on their back surface.
- Technical report24 pagesEnglish languagesale 15% off
This International Standard applies to displays of high-contrast text that are designed for general near vision assessment. It does not apply to measurement systems designed for specialized testing of near visual acuity, e.g., low vision or low contrast charts or those intended for transillumination, or electronically generated systems.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.
- Standard73 pagesEnglish and French languagesale 15% off
- Draft31 pagesEnglish languagesale 15% off
IEC 80601-2-58:2024 is available as IEC 80601-2-58:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005.
IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards;
c) updated normative references;
d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101;
e) adding the shadow light method in 201.12.1.101.7;
f) clarify test conditions for EMC requirements in 202.7.1.2;
g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”;
h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB);
i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.
- Standard121 pagesEnglish languagesale 15% off
- Standard79 pagesEnglish and French languagesale 15% off
This document applies to printed, projected, and electronic displays of high-contrast text that are designed for assessment and measurement of near reading acuity under photopic conditions.
The definitions and requirements of this document apply to the Latin alphabet.
- Standard16 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.
- Standard59 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies reference's test methods for determining the properties of sunglasses given in
ISO 12312 (all parts). It is applicable to all sunglasses and related eyewear.
Other test methods can be used if proven to be equivalent.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This document applies to printed, projected, and electronic displays of high-contrast text that are designed for assessment and measurement of near reading acuity under photopic conditions. The definitions and requirements of this document apply to the Latin alphabet.
- Standard8 pagesEnglish languagesale 15% off
- Standard9 pagesFrench languagesale 15% off
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
- Standard59 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.
- Standard51 pagesEnglish languagesale 15% off
- Standard53 pagesFrench languagesale 15% off
This document specifies requirements for reference lenses for the calibration and verification of focimeters that are used for the measurement of spectacle form lenses, e.g. those complying with ISO 8598-1. It also gives a method for the determination of the back vertex power of the reference lenses.
NOTE It is accepted that other reference lenses can also be used with powers within the given range, manufactured to the same standard of accuracy and form, but different back vertex powers. However, only lenses with integer nominal powers, as described in 4.1, can be used for the calibration of digitally-rounding focimeters.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for reference lenses for the calibration and verification of focimeters that are used for the measurement of spectacle form lenses, e.g. those complying with ISO 8598-1. It also gives a method for the determination of the back vertex power of the reference lenses.
NOTE It is accepted that other reference lenses can also be used with powers within the given range, manufactured to the same standard of accuracy and form, but different back vertex powers. However, only lenses with integer nominal powers, as described in 4.1, can be used for the calibration of digitally-rounding focimeters.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for reference lenses for the calibration and verification of focimeters that are used for the measurement of spectacle form lenses, e.g. those complying with ISO 8598-1. It also gives a method for the determination of the back vertex power of the reference lenses. NOTE It is accepted that other reference lenses can also be used with powers within the given range, manufactured to the same standard of accuracy and form, but different back vertex powers. However, only lenses with integer nominal powers, as described in 4.1, can be used for the calibration of digitally-rounding focimeters.
- Standard19 pagesEnglish languagesale 15% off
- Standard19 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.
- Standard16 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, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
This document is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
This document is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for the transmittance properties of uncut and unmounted finished spectacle lenses, including attenuation of solar radiation.
This document is not applicable to
— spectacle lenses having specific transmittance or absorption characteristics prescribed for medical reasons,
— products to which specific personal protective equipment transmittance standards apply, and
— products intended for direct observation of the sun, such as for solar-eclipse viewing.
NOTE 1 By reference to ISO 21987 and ISO 14889, this document also applies to lenses mounted in spectacles.
NOTE 2 Optical and geometric requirements are given for uncut finished spectacle lenses in ISO 8980‑1 and ISO 8980‑2, and for mounted lenses, in ISO 21987.
- Standard42 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, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
This document is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
This document is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.
- Standard12 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, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus. This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist. This document is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories. This document is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.
- Standard5 pagesEnglish languagesale 15% off
- Standard5 pagesFrench languagesale 15% off
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
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
This document is applicable to all afocal (plano power) sunglasses and clip-ons for general use, including
road use and driving, intended for protection against solar radiation.
Information on the use of sunglass filters is given in Annex A. Requirements for unmounted filters used
as replacement or alternative filters are given in Annex C.
This document is not applicable to:
a) eyewear for protection against radiation from artificial light sources;
b) eye protectors intended for specific sports (e.g. ski goggles or other types – see ISO18527 (all parts));
c) sunglasses that have been medically prescribed for attenuating solar radiation;
d) products intended for direct observation of the sun, such as for viewing a partial or annular solar
eclipse, for which ISO 12312-2 applies;
e) products intended for occupational eye protection – see, for example, ISO 16321 (all parts)
- Standard40 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 specifies requirements for the transmittance properties of uncut and unmounted
finished spectacle lenses, including attenuation of solar radiation.
This document is not applicable to
— spectacle lenses having specific transmittance or absorption characteristics prescribed for medical
reasons,
— products to which specific personal protective equipment transmittance standards apply, and
— products intended for direct observation of the sun, such as for solar-eclipse viewing.
NOTE 1 By reference to ISO 21987 and ISO 14889, this document also applies to lenses mounted in spectacles.
NOTE 2 Optical and geometric requirements are given for uncut finished spectacle lenses in ISO 8980-1
and ISO 8980-2, and for mounted lenses, in ISO 21987.
- Standard42 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for the transmittance properties of uncut and unmounted finished spectacle lenses, including attenuation of solar radiation. This document is not applicable to — spectacle lenses having specific transmittance or absorption characteristics prescribed for medical reasons, — products to which specific personal protective equipment transmittance standards apply, and — products intended for direct observation of the sun, such as for solar-eclipse viewing. NOTE 1 By reference to ISO 21987 and ISO 14889, this document also applies to lenses mounted in spectacles. NOTE 2 Optical and geometric requirements are given for uncut finished spectacle lenses in ISO 8980‑1 and ISO 8980‑2, and for mounted lenses, in ISO 21987.
- Standard34 pagesEnglish languagesale 15% off
- Standard35 pagesFrench languagesale 15% off
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
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
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
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
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.
- Standard6 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
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.
- Standard19 pagesEnglish languagesale 15% off
- Standard20 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.
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
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
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
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
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
- Standard26 pagesEnglish languagesale 15% off
- Standard27 pagesFrench languagesale 15% off
- Standard27 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. 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.
- Standard22 pagesEnglish languagesale 15% off
- Standard22 pagesEnglish languagesale 15% off
- Standard22 pagesFrench languagesale 15% off
- Standard22 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
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
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 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
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
- Amendment10 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesEnglish languagesale 15% off
- Standard5 pagesFrench 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
- Standard27 pagesEnglish languagesale 15% off
- Standard28 pagesFrench languagesale 15% off
- Standard28 pagesFrench languagesale 15% off
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
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
2019-12-04 - not allocated for publication because of missing TC decision to skip FV.
- Amendment7 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
- Standard16 pagesEnglish languagesale 15% off
- Standard18 pagesFrench languagesale 15% off
- Standard18 pagesFrench languagesale 15% off