ISO/TC 172 - Optics and photonics

This document gives general guidance on evaluating the sources of error in optical transfer function (OTF) equipment and in using this information to estimate errors in a measurement of OTF. It also gives guidance on assessing and specifying a general uncertainty for a specific measuring equipment, as well as recommending methods of routine assessment. The main body of this document deals exclusively with the modulation transfer function (MTF) part of the OTF. The phase transfer function (PTF) is dealt with relatively briefly in Annex A.

This document specifies a method for testing the resistance of raw optical glasses to attack by aqueous alkaline phosphate-containing detergent solutions (phosphate solutions) at 50 °C and a classification of optical glasses according to the aqueous alkaline phosphate-containing detergent resistance (phosphate resistance) determined by this method. This document is applicable to samples of raw optical glasses.

This document defines terms used in conjunction with, and the general principles of, test methods for determining the laser-induced damage threshold and for the assurance of optical laser components subjected to laser radiation.

This document specifies the measurement method used for calculating the temperature coefficient of the refractive index by measuring the refractive index, which changes with the temperature of the optical glass using the minimum deviation method. The intended temperature range for the specified measurement method is –40 °C to +80 °C. The intended wavelength range for the specified measurement method is 365 nm to 1 014 nm. The intended accuracy for the specified measurement method is 1 × 10-6 K-1.

This document specifies a field procedure for the verification that a given Global Navigation Satellite System (GNSS)-based system and measurement procedure meets a required measurement uncertainty at the location and time of interest. The field procedure uses three-dimensional coordinates which are compared to reference coordinates. It is designed to be applicable to the technically versatile geodetic and surveying GNSS systems on the market and can be used for any kind of GNSS-based applications to determine coordinates. It is independent of the technology used in the GNSS measuring instrument, the satellite data streams, and any correction data used. The procedure is applicable to GNSS instruments under operating condition in the field in such a way that the main parameters affecting the determination of coordinates are included in the result of the test. This document defines several delimitation criteria, which allows for versatile applicability. As a result, the verification procedure can be regularly performed in the field with limited economic impact.

This document specifies field procedures to be adopted when determining and evaluating the precision (repeatability) of rotating lasers, the uncertainty of measurement results obtained by geodetic instruments and their ancillary equipment, particularly when used in building and surveying measurements for levelling tasks. Primarily, these tests are intended to be field verifications of the suitability of a particular instrument for the immediate task at hand and to satisfy the requirements of other standards. They are not proposed as tests for acceptance or performance evaluations that are more comprehensive in nature. This document can be considered as one of the first steps in the process of evaluating the uncertainty of a measurement (more specifically a measurand). The uncertainty of a result of a measurement is dependent on a number of parameters. Therefore, this document differentiates between various quality measures and testing objectives, including repeatability and reproducibility (between-day repeatability), and provides a thorough assessment of all potential error sources, as specified by ISO/IEC Guide 98-3 and ISO 17123-1. These field procedures have been developed specifically for in situ applications without the need for special ancillary equipment and are purposefully designed to minimize atmospheric influences.

This document specifies the minimum information to be provided to the user by the manufacturers of microscopes with digital displays regarding imaging performance. It further specifies terms and definitions for describing the optical performance of the digital imaging path of microscopy systems including the observation of the image on digital displays. This standard does not apply to confocal microscopes. NOTE Terms and definitions for the direct visual observation with eyepieces are specified in ISO 8039 and ISO 10934.

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).

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.

This document gives requirements for general and high purpose binoculars, monoculars and spotting scopes.

This document specifies test methods for determining the radiant power and radiant energy of continuous wave and pulsed laser beams, as well as their temporal characteristics of pulse shape, pulse duration and pulse repetition rate. Test and evaluation methods are also given for the radiant power stability of cw-lasers, radiant energy stability of pulsed lasers and pulse duration stability. The test methods given in this document are used for the testing and characterization of lasers.

This document specifies the rules for indicating centring and tilt tolerances for optical elements, subassemblies, and assemblies in the ISO 10110 series, which standardizes drawing indications for optical elements and systems. This document applies to plano surfaces, rotationally invariant (spherical and aspherical) surfaces, circular and non-circular cylindrical (cylindrical and acylindrical) surfaces, and non-symmetrical surfaces (general surfaces). General surfaces are described using ISO 10110-19.

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.

This document specifies the principle, apparatus, condition, sample, procedure and data processing of measuring striae in infrared optical materials. It is applicable for the determination of striae in infrared optical materials, such as infrared optical glass, which is opaque to visible wavelengths and whose transmission optical spectra are beyond 0,78 µm.

This document specifies terms and definitions to be used in the field of light microscopy and advanced techniques in light microscopy.

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.

This document specifies the default (implicit) tolerances for indication in the ISO 10110 series, which standardizes drawing indications for optical elements and systems.

This document gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

This document gives general guidance for the construction and use of equipment for measurement of the optical transfer function (OTF) of imaging systems. This document specifies important factors that can influence the measurement of the OTF and gives general rules for equipment performance requirements and environmental controls. It specifies important precautions that should be taken to ensure accurate measurements and correction factors to be applied to the collected data. The OTF measuring equipment described in this document is restricted to that which analyses the radiation distribution in the image plane of the optical imaging system under test. Interferometer-based instruments are outside the scope of this document.

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.

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.

This document specifies methods by which the spectral characteristics such as wavelength, bandwidth, spectral distribution and wavelength stability of a laser beam can be measured. This document is applicable to both continuous wave (cw) and pulsed laser beams. The dependence of the spectral characteristics of a laser on its operating conditions may also be important.

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.

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.

This document specifies methods for testing geometrical properties of microlenses in microlens arrays. It is applicable to microlens arrays with very small lenses formed on one or more surfaces of a common substrate and to graded-index microlenses.

This document specifies methods for testing wavefront aberrations for microlenses within microlens arrays. It is applicable to microlens arrays with very small lenses formed inside or on one or more surfaces of a common substrate.

This document specifies methods for testing optical properties, other than wavefront aberrations[1] of microlenses in microlens arrays. It is applicable to microlens arrays with very small lenses formed on one or more surfaces of a common substrate and to graded-index microlenses.

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.

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.

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).

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.

This document defines chalcogenide glass correctly from a chemical perspective and specifies basic characterization and reporting of optical properties of chalcogenide glass used in the infrared spectral range from 0,78 um to 25 um

This document specifies the use of the marking on objectives for polarization microscopes and defines measurands and measurement procedures of polarization characteristics of the objectives for qualitative polarization imaging. These measurements are defined on the image plane of the objective lens. This marking is consistent with ISO 8578. NOTE This document does not apply to objectives exclusively used on stereomicroscopes.

This document specifies a test method for the temperature coefficient of refractive index of optical glass using interferometry. Temperature changes in optical glass lead to changes in the optical path length. The change in optical path length can be measured with an interferometer using the number of cycles of light/dark change of the interference stripe. This document defines a test method to measure the amount of change in the refractive index when the temperature of the specimen is changed continuously. The intended temperature range for the specified measurement method is an arbitrary range. The intended wavelength range for the specified measurement method is 365 nm to 1 014 nm. The intended accuracy for the specified measurement method is within 1 × 10-6 K-1.

This document specifies the measurement method used for calculating the temperature coefficient of the refractive index by measuring the refractive index, which changes with the temperature of the optical glass using the minimum deviation method. The intended temperature range for the specified measurement method is –40 °C to +80 °C. The intended wavelength range for the specified measurement method is 365 nm to 1 014 nm. The intended accuracy for the specified measurement method is 1 × 10-6 K-1.

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.

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.

ISO 9211 (series) describes surface treatments of components and substrates excluding ophthalmic optics (spectacles) by the application of optical coatings and gives a standard form for their specification. It defines the general characteristics and the test and measurement methods whenever necessary, but it is not intended to define the process method. This document specifies general use and standard categories of use for optical coatings and identifies which environmental tests are necessary to prove that the coatings meet the required specification. The mechanical and chemical properties of coated optical elements, and more generally their environmental durability, can be assessed by a variety of methods. The test methods are generally described in various parts of ISO 9022 and in ISO 9211-4. These test methods are selected to give meaningful results representative of actual exposure of optical elements in their operating environment, alternatively to the minimum requirements as described in ISO 9211-5 to ISO 9211-8, which are coating type related.

This document indicates how to specify optical properties of coatings and to represent their spectral characterization graphically in the ISO 9211 series, which defines the specifications for optical coatings excluding ophthalmic optics (spectacles). It defines the general characteristics and the test and measurement methods whenever necessary, but is not intended to define the process method.

This document contains tables for environmental tests and test parameters which can be used as a guideline for the selection of environmental tests. These include the selection of standardized tests according to ISO 9022 as well as additional parameters not described in ISO 9022 and necessary for the optical or photonic instruments. Ultimately, these tables specify the requirements to be met with regard to the reliability of the optical, mechanical, chemical, and electrical properties or performance characteristics of the instruments when exposed to environmental influences. Environmental test methods, as specified in ISO 9022 (all parts), can be assigned to the various areas of application for the purpose of ascertaining the suitability of the instruments in the respective area of application.

This document defines terms relevant to optical coatings. These terms are grouped in four classes: Terms and definitions, definition of coatings by function, definitions of common coating imperfections and other definitions. This document identifies surface treatments of components and substrates excluding ophthalmic optics (spectacles) by the application of optical coatings and gives a standard form for their specification. It defines the general characteristics and the test and measurement methods whenever necessary, but is not intended to define the process method.

This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

This document specifies two methods for testing the resistance of raw optical glasses to attack by aqueous acidic solutions and defines a classification of optical glasses according to the acid resistance determined by these methods. The surface method tests the resistance of the polished plate-shaped optical glass to attack by aqueous acidic solutions at 25 °C for a specified time and indicates the class determined by this method as “SR-S”. The powder method tests the resistance of crushed granular optical glass to attack by an acidic aqueous solution at above 98 °C for 1 h, and indicates the class determined by this method as “SR-P”.

This document provides general methods of describing surfaces adding a diffractive optical function on optical surfaces, such as planes, spheres, aspheres or general optical surfaces, in the ISO 10110 series, which standardizes drawing indications for optical elements and systems. The subject of this document is the presentation, description and dimensioning of diffractive surfaces in technical drawings. This document does not apply to diffractive surfaces with random surface texture, for example stochastic antireflective structures. Also not addressed by this document are all types of 3-dimensionally extended diffractive structures: Bragg gratings, volume holograms (HOE) and acousto-optic modulators. This document does not address the methods to test and qualify the specifications. This document does not address tools and methods for manufacturing diffractive surfaces.

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.

This document specifies test methods for the determination of the linear optical phase retardation of optical components by polarized laser beams.

This document specifies procedures for the absorption measurement and high spatial-resolution two-dimensional or three-dimensional absorption mapping of optical laser components, and upon calibration, the measurement of absolute absorptance of laser optics. The methods given in this document are intended to be used for the two-dimensional or three-dimensional absorption mapping of optical laser components, that is, measurement of absorption as a function of position, as well as absorption/absorptance measurement and mapping of laser optics used in high-power/high-energy laser systems.

This document specifies the methods relating to the environmental tests of optical instruments including additional assemblies from other fields (e.g. mechanical, chemical, and electronic devices), under equivalent conditions, for their ability to resist the influence of low pressure combined with cold, including the potential condensation and freezing of moisture, ambient temperature, and dry or damp heat. This document is applicable to optical instruments including additional assemblies from other fields, designed for operation and/or transport in high mountainous areas or on board aircraft or missiles. The purpose of the testing is to investigate to what extent optical, climatic, mechanical, chemical, and electrical (including electrostatic) performance characteristics of the specimen are affected by combined low pressure and low, ambient, or high temperature. Furthermore, the additional effects of moisture condensing and freezing on the instrument or components can be determined. Examples are instruments which are installed or externally mounted on aircraft or missiles or transported inside aircraft or flying objects not providing any pressure equalization. Annex A explains the intent of the different types of tests.