11.040.70 - Ophthalmic equipment
ICS 11.040.70 Details
Ophthalmic equipment
Augenmedizinische Gerate
Matériel ophtalmique
Oftalmološka oprema
General Information
Frequently Asked Questions
ICS 11.040.70 is a classification code in the International Classification for Standards (ICS) system. It covers "Ophthalmic equipment". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 841 standards classified under ICS 11.040.70 (Ophthalmic equipment). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document specifies requirements for the optical and geometrical properties of semi-finished blanks.
- Draft18 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the optical and geometrical properties of semi-finished blanks.
- Standard16 pagesEnglish languagesale 15% off
- Standard17 pagesFrench languagesale 15% off
This document contains definitions of terms related to intraocular lenses as well as definitions related to the methods used to evaluate these IOLs.
NOTE The terms are listed in the alphabetical order of the English terms.
- Standard20 pagesEnglish languagee-Library read for1 day
This document specifies quality requirements for the chart, test procedure and acceptance level for near, far, and colour vision acuity of NDT personnel. Information for grey scale perception and low contrast can be found in the annexes. This document also specifies the qualification requirements for personnel permitted to carry out the test.
This document is only applicable to vision acuity under defined conditions similar to those encountered during routine NDT inspection. This document does not address an individual’s overall visual acuity and users are advised to consider the need for a general eye examination by specialist medical personnel to ensure general vision acuity.
- Draft21 pagesEnglish languagee-Library read for1 day
This document specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
NOTE This document attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there can be additional national requirements.
- Standard15 pagesEnglish languagee-Library read for1 day
This document contains definitions of terms related to intraocular lenses as well as definitions related to the methods used to evaluate these IOLs.
NOTE The terms are listed in the alphabetical order of the English terms.
- Standard20 pagesEnglish languagee-Library read for1 day
This document specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
NOTE This document attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there can be additional national requirements.
- Standard15 pagesEnglish languagee-Library read for1 day
This document contains definitions of terms related to intraocular lenses as well as definitions related to the methods used to evaluate these IOLs. NOTE The terms are listed in the alphabetical order of the English terms.
- Standard11 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
This document specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging. NOTE This document attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there can be additional national requirements.
- Standard7 pagesEnglish languagesale 15% off
- Standard8 pagesFrench languagesale 15% off
This document specifies test procedures for determining the stability of contact lenses once they are placed in their final packaging during storage and distribution.
NOTE The results obtained can be used for determining the expiry date.
- Standard15 pagesEnglish languagee-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.
Preservative uptake and release testing is not intended as a routine test of production contact lenses or contact lens care products nor are testing results meant to establish finished goods specifications in any way.
Such testing is carried out when developing new contact lens materials and/or contact lens care products.
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 languagee-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.
Preservative uptake and release testing is not intended as a routine test of production contact lenses or contact lens care products nor are testing results meant to establish finished goods specifications in any way.
Such testing is carried out when developing new contact lens materials and/or contact lens care products.
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 languagee-Library read for1 day
This document specifies test procedures for determining the stability of contact lenses once they are placed in their final packaging during storage and distribution.
NOTE The results obtained can be used for determining the expiry date.
- Standard15 pagesEnglish languagee-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. Preservative uptake and release testing is not intended as a routine test of production contact lenses or contact lens care products nor are testing results meant to establish finished goods specifications in any way. Such testing is carried out when developing new contact lens materials and/or contact lens care products. 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.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesFrench languagesale 15% off
This document specifies test procedures for determining the stability of contact lenses once they are placed in their final packaging during storage and distribution. NOTE The results obtained can be used for determining the expiry date.
- Standard7 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm−2·week−1 set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.
- Standard49 pagesEnglish languagee-Library read for1 day
This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm−2·week−1 set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.
- Standard49 pagesEnglish languagee-Library read for1 day
This document 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.
This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
- Standard34 pagesEnglish languagee-Library read for1 day
This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer.
This document is applicable to:
— all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames;
— spectacle frames made with additive manufacturing, for example, 3D printing;
— spectacle frames made from natural organic materials;
— the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply;
— prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask.
Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1.
NOTE See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames.
This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.
- Standard50 pagesEnglish languagee-Library read for1 day
This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer.
This document is applicable to:
— all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames;
— spectacle frames made with additive manufacturing, for example, 3D printing;
— spectacle frames made from natural organic materials;
— the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply;
— prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask.
Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1.
NOTE See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames.
This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.
- Standard50 pagesEnglish languagee-Library read for1 day
This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.
NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.
NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).
- Standard39 pagesEnglish languagee-Library read for1 day
This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.
NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.
NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).
- Standard39 pagesEnglish languagee-Library read for1 day
This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products. NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document. NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).
- Standard30 pagesEnglish languagesale 15% off
- Standard33 pagesFrench languagesale 15% off
This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses.
This document takes precedence over the corresponding requirements of other standards, if differences exist.
- Standard21 pagesEnglish languagee-Library read for1 day
This document 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.
This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
- Standard34 pagesEnglish languagee-Library read for1 day
This document 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. This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
- Standard26 pagesEnglish languagesale 15% off
- Standard27 pagesFrench languagesale 15% off
This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses.
This document takes precedence over the corresponding requirements of other standards, if differences exist.
- Standard21 pagesEnglish languagee-Library read for1 day
This document applies to anomaloscopes used to examine red-green-colour vision by investigating the colour match of a mixture of red and green compared with yellow, known as the “Rayleigh equation”. This document specifies the requirements for optical and technical parameters, which are of physiological relevance to ensure that the measured values on the eye of the examinee are independent of the technical characteristics of the anomaloscope used.
- Standard11 pagesEnglish languagesale 15% off
This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses. This document takes precedence over the corresponding requirements of other standards, if differences exist.
- Standard7 pagesEnglish languagesale 15% off
- Standard8 pagesFrench languagesale 15% off
This document 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. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes.
NOTE For the purpose of this document, optical radiation relates to the wavelength range of 250 nm to 2 500 nm.
This document does not apply to therapeutic radiation. However, in the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target tissues, the limits given in this document may be applied to those parts of the treatment beam that strike non-target tissue.
Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in ISO 15004-2, then those in the vertical International Standard take precedence.
This document classifies ophthalmic instruments into either Group 1 or Group 2 to distinguish instruments that are non-hazardous from those that are potentially hazardous.
- Standard65 pagesEnglish languagee-Library read for1 day
- Amendment6 pagesEnglish languagee-Library read for1 day
This document specifies reference wavelengths to be used for the characterization of optical materials, optical systems and instruments, and ophthalmic lenses. It defines the associated principal refractive indices and principal dispersions, as well as the Abbe numbers with regard to these reference wavelengths and principal dispersions.
- Standard11 pagesEnglish languagee-Library read for1 day
This document 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. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes.
NOTE For the purpose of this document, optical radiation relates to the wavelength range of 250 nm to 2 500 nm.
This document does not apply to therapeutic radiation. However, in the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target tissues, the limits given in this document may be applied to those parts of the treatment beam that strike non-target tissue.
Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in ISO 15004-2, then those in the vertical International Standard take precedence.
This document classifies ophthalmic instruments into either Group 1 or Group 2 to distinguish instruments that are non-hazardous from those that are potentially hazardous.
- Standard65 pagesEnglish languagee-Library read for1 day
This document 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. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes. NOTE For the purpose of this document, optical radiation relates to the wavelength range of 250 nm to 2 500 nm. This document does not apply to therapeutic radiation. However, in the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target tissues, the limits given in this document may be applied to those parts of the treatment beam that strike non-target tissue. Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in ISO 15004-2, then those in the vertical International Standard take precedence. This document classifies ophthalmic instruments into either Group 1 or Group 2 to distinguish instruments that are non-hazardous from those that are potentially hazardous.
- Standard56 pagesEnglish languagesale 15% off
- Standard62 pagesFrench languagesale 15% off
This document specifies reference wavelengths to be used for the characterization of optical materials, optical systems and instruments, and ophthalmic lenses. It defines the associated principal refractive indices and principal dispersions, as well as the Abbe numbers with regard to these reference wavelengths and principal dispersions.
- Standard11 pagesEnglish languagee-Library read for1 day
This document specifies a test method to be used in evaluating the antimicrobial activity of products for contact lens disinfection by chemical methods using the trophozoite form of Acanthamoeba species as the challenge organism. This document is not applicable to the evaluation of oxidative systems that require a special lens case for use.
- Standard26 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous vision, and/or accommodative optics. The generic descriptor ‘IOL’ used throughout this document also includes phakic intraocular lenses (PIOL).
- Standard30 pagesEnglish languagee-Library read for1 day
This document specifies reference wavelengths to be used for the characterization of optical materials, optical systems and instruments, and ophthalmic lenses. It defines the associated principal refractive indices and principal dispersions, as well as the Abbe numbers with regard to these reference wavelengths and principal dispersions.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer. This document is applicable to: — all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames; — spectacle frames made with additive manufacturing, for example, 3D printing; — spectacle frames made from natural organic materials; — the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply; — prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask. Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1. NOTE See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames. This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.
- Standard36 pagesEnglish languagesale 15% off
- Standard37 pagesFrench languagesale 15% off
This document specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous vision, and/or accommodative optics. The generic descriptor ‘IOL’ used throughout this document also includes phakic intraocular lenses (PIOL).
- Standard30 pagesEnglish languagee-Library read for1 day
This document 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. This document specifies characteristics and minimum requirements for OCT instruments and systems. It specifies type tests and procedures to verify that a system or instrument qualifies as an OCT instrument or system in accordance with this document. NOTE In this document the term OCT refers to ophthalmic applications.
- Standard15 pagesEnglish languagesale 15% off
This document describes the methods currently used in applying tolerances to the focal powers of spectacle lenses and methods that can be considered for adoption in the future; it also describes methods of measuring the prism imbalance (relative prism error) between the lenses of a mounted pair. The results of a 2014 survey of manufacturing capability for lens power and a 2018 international web survey are discussed, as are possible new methods for applying tolerances to the focal power of spectacle lenses.
- Technical report50 pagesEnglish languagesale 15% off
- Technical report52 pagesFrench languagesale 15% off
This document specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous vision, and/or accommodative optics. The generic descriptor ‘IOL’ used throughout this document also includes phakic intraocular lenses (PIOL).
- Standard22 pagesEnglish languagesale 15% off
- Standard22 pagesFrench 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.
- Standard43 pagesEnglish languagee-Library read for1 day
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.
- Standard43 pagesEnglish languagee-Library read for1 day
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 document specifies proposals for the tolerances and methods for measuring the base and add power of refractive/symmetric multifocal contact lenses. This document is not intended to measure current production lenses (or similar) and does not include measurement of diffractive multifocal contact lenses nor the measurement of distance (or label) power. This document is intended to obtain additional feedback from clinicians, manufacturers, and health authorities on the proposals for tolerances and test methods. This document is not intended to be used in any quality system or by any governing body to control the manufacturing or acceptance of contact lenses.
- Technical specification20 pagesEnglish 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 languagee-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 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.
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