ISO - International Organization for Standardization

This document defines test methods for surgical standard instruments. This document does not cover instruments for use on the central nervous system and on the central cardiovascular system.

This document provides good practice that can be adopted by any service provider, not limited to e-hailing and p-hailing operators, for the implementation of work-related road traffic safety (RTS) management. This document is applicable to any service provider to offer further protection to the drivers for digital platform providers as well as other road users through the adoption of a proactive approach to manage work-related road risks.

This document gives guidance on the development of a facility management (FM) organization working on the strategic, tactical and operational management levels to: satisfy the needs and objectives of the demand organization and users of its facility; meet the needs of stakeholders and applicable FM requirements consistently; provide a safe, healthy, secure and efficient environment that enhances the workplace experience for users; protect the asset value and resource value of the facility; provide appropriately specified, responsive and cost-effective facility services; implement measures to minimize the impact of climate change on the facility; contribute to goals and targets consistent with sustainable development; improve the usefulness and benefits provided by the FM system.

This document specifies methods for the determination of basic measurements of surgical standard instruments. This document does not apply to instruments for use on the central nervous system and on the central cardiovascular system. NOTE Instruments for use on the central nervous system and on the central cardiovascular system are measured differently due to complex geometries which are adapted to the human anatomy.

This document specifies the heating condition, method of test and criteria for the evaluation of the ability of a penetration sealing system to maintain the integrity and insulation of a fire-separating element at the position at which it has been penetrated. This document assesses: the effect of such penetrations on the integrity and insulation performance of the element concerned, the integrity and insulation performance of the penetration sealing system, and the insulation performance of the penetrating service or services, and where appropriate, the integrity failure of a service. NOTE 1 Optional water and air leakage tests are included in Annex A. NOTE 2 Explanatory notes are included in Annex B.

This document describes a method that demonstrates the use of polyethylene reference film (PERF) for monitoring laboratory and outdoor conditions as a weathering reference material in weathering tests used for plastics.

This document describes methods for simulating the mechanical loads that can be imparted to passive fire protection (PFP) materials and systems by explosions resulting from releases of flammable gas, pressurized liquefied gas, flashing liquid fuels, or dust that can precede a fire. These methods can be used to determine the resistance of passive fire protection materials to such events. This document considers PFP materials applied to substrates that are subject to the combined effects of pressure and drag that occur in the flow path of an explosion. This document excludes specimens in which the substrate is subject to plastic deformation or brittle failure.

This document specifies requirements and recommendations for the design, development and implementation of predictive computational models for research purposes in the field of personalized medicine and health product development. This document addresses the set-up, formatting, validation, simulation, storing and sharing of computational models used for personalized medicine. Requirements and recommendations for data used to construct or required for validating such models are also specified. This includes rules for formatting, descriptions, annotations, interoperability, integration, access and provenance of such data. This document does not apply to computational models used for standard routine clinical, diagnostic or therapeutic purposes.

This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty. This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1. When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM. Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.

This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine. This document applies to: RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties; any person, body or institution developing RMPs for measurands used in laboratory medicine.

This document describes a method to expose test organisms (amphipods), directly on the field by a caging methodology, with the aim to measure bioaccumulation of chemical substances on a monitoring station, i.e. either the concentrations of metals or organic compounds, or both, accumulated in the organisms. This document also describes the specifications for test organism selection and conditioning, in situ exposure, and finally sorting and conditioning of the surviving organisms after exposure. This document does not apply to organism preparation methods (freeze-drying, extraction, mineralization) and quantification of the chemical substances.

This document specifies a test method using radioactive methyl iodide (CH3131I) as a tracer to determine the in-situ decontamination factor of an iodine trap. An in-situ test allows to reach the global efficiency of the trap characterized by the sorbent efficiency but also by the implementation of the trap within the ventilation duct) while the intrinsic efficiency of a charcoal is characterized in a laboratory by ISO 18417[9] (or other national standards such as ASTM D3803[10]). This document provides general and common requirements for this method to assess the efficiency of an iodine trap, but also, the tools requirements, accuracy and the provisions needed to ensure safety of the workers, public and the environment during the test. This reproducible method can support nuclear facility operators as a reference method to compare the decontamination factor evaluated by this method to reference values (e.g. safety criteria, national legislation, etc.). Because of the use of a radioactive tracer, some precautions should be applied. Firstly, this method is usually used for ventilation systems with monitoring of gaseous iodine releases in environment in accordance with the national regulations. Secondly, this method is not used to determine the decontamination factor of iodine traps used in ventilation systems with air release in rooms with potential presence of workers (e.g. control room). For those rooms, a non-radioactive method is preferred. This document can apply to installations with low inventory of radioiodine equipped with iodine traps (e.g. small laboratories). In this case, some provisions can be adapted but always in accordance with the national regulations. Finally, this document mainly deals with iodine traps using impregnated activated carbon. However, this method can be used with some adaptations to other solid sorbent as inorganic sorbent (e.g. zeolite – aluminium and silica base usually doped with silver nitrate – or impregnated catalytic supports[11][12]).

This document specifies a method for determining the resistance of the colour of textiles of all kinds and in all forms to ironing and to processing on hot cylinders. This document is applicable for hot pressing when the textile is dry, damp or wet which is determined by the end-use of the textile.

This document provides requirements and guidelines for the characterization of native species of plants, algae and fungi and the products derived from them, which have been collected, harvested or processed. This document aims to enable the establishment of minimum quality and safety requirements considering sustainable management of biodiversity. This document also covers the protection of biodiversity along all steps of the value chain of the products derived from native species through the application of a biodiversity management plan. This document does not apply to native animal species, timber and wood products.

This document specifies requirements and guidance for production assurance and reliability management as applicable to the assets and operations associated with exploration drilling, exploitation, processing and transport of petroleum, petrochemical and natural gas resources. It covers the assets and associated activities for upstream, midstream, downstream and petrochemical business categories. It focuses on the production assurance of oil and gas with respect to production and associated activities and covers the analysis of reliability and maintenance of the equipment. This includes a variety of associated systems and equipment in the oil and gas value chain. Production assurance addresses not only hydrocarbon production, but also associated activities such as drilling, pipeline installation and subsea intervention. The document also supports production assurance and reliability management for lower carbon energy assets and associated operations, e.g. carbon capture and storage (CCS), hydrogen, ammonia, and wind energy. It describes the processes, activities, requirements and guidelines for systematic management, effective planning, execution and use of production assurance and reliability technology. This document defines 12 processes, of which seven are denoted as core production assurance processes and addressed in this document. The remaining five processes are denoted as interacting processes and while they are outside the scope of this document, information is provided as to how they relate to production assurance and reliability management. The relationship of the core production assurance processes with these interacting processes, however, is within the scope of this document as the flow of information to and from these latter processes is required to ensure that production assurance requirements are fulfilled. The document specifies how to establish and execute a production assurance programme (PAP) and a reliability management programme (RMP). This document lists processes and activities that can be initiated to add value for the stakeholder (e.g. operator), where the selected process can depend on their business strategy and application area. This document is intended for the following users and associated activities by their personnel: Operators: Production assurance and reliability management activities. Related activities include project management and control, technology development, technology qualification, concept and system design, risk management (including HSE), integrity management, and maintenance management. Contractors: Activities by the main contractor for engineering, procurement, construction, drilling, installation, operation, maintenance services, etc. Vendors: Activities by manufacturer or supplier related to equipment design and quality management, technology development and qualification. Authorities: Activities by regulatory bodies to ensure HSE, resource utilization and economic efficiency in operations. Consultants: Consultancy services aimed at supporting production assurance and reliability management. Universities: Activities associated with educating industry professionals, as well as conducting fundamental or applied research projects, when related to production assurance, reliability management, and technology development. This includes improvement of the methods and frameworks described herein. Research institutions: Research activities related to production assurance, reliability management, and technology development. This includes equipment qualification testing and advanced engineering assessments using the methods and frameworks described herein.

This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2]. This document does not apply to MLMD employing large language models (LLM) or generative AI.

This document specifies the method of instrumented indentation test for determination of hardness and other materials parameters for the following three ranges: macro range: 2 N ≤ F ≤ 30 kN; micro range: 2 N > F; h > 0,2 µm; nano range: h ≤ 0,2 µm. For the nano range, the mechanical deformation strongly depends on the real shape of indenter tip and the calculated material parameters are significantly influenced by the contact area function of the indenter used in the testing machine. Therefore, careful calibration of both instrument and indenter shape is required in order to achieve an acceptable reproducibility of the materials parameters determined with different machines. The macro and micro ranges are distinguished by the test forces in relation to the indentation depth. Attention is drawn to the fact that the micro range has an upper limit given by the test force (2 N) and a lower limit given by the indentation depth of 0,2 µm. The determination of hardness and other material parameters is given in the normative Annex A. At high contact pressures, damage to the indenter is possible. For test pieces with very high hardness and modulus of elasticity, permanent indenter deformation can occur and can be detected using suitable reference materials. Indentations that result in damage or permanent deformation of the indenter are excluded from the scope of this test method. This test method can also be applied to thin metallic and non-metallic coatings and non-metallic materials. In this case, it is recommended that the specifications in the relevant standards be taken into account (see also 7.3 and ISO 14577-4). The analysis methods of this standard assume that materials behave like ideal materials. Any deviation (internal stress, pile-up, sink-in, densification, phase transitions, cracks) will result in additional uncertainties. This becomes especially important if comparisons shall be done to material parameters, obtained with other methods.

This document provides requirements and recommendations for the design of field studies with soil invertebrates (e.g. for the monitoring of the quality of a soil as a habitat for organisms). It applies to all terrestrial biotopes inhabited by soil invertebrates, although this information can vary according to the national requirements or the climatic and regional conditions of the site to be sampled. NOTE While this document aims to be applicable globally, the existing information refers mostly to temperate regions. However, the (few) studies from other (tropical and boreal) regions, as well as theoretical considerations, allow the conclusion that the principles laid down in this document are generally valid.[1]],[[11]],[[12]],[[13]

This document describes a method for the determination of the acute toxicity to one of three specified species of marine copepod (Copepoda, Crustacea). This document is applicable to: industrial or sewage effluents, treated or untreated, after decantation, filtration or centrifugation if necessary; marine or estuarine waters; )aqueous extracts (pore water, elutriates, eluates and leachates) from sediments; chemical substances which are soluble, or which can be maintained as a stable suspension or dispersion, under the conditions of the test.

This document specifies the main characteristics and test methods of new fibre ropes used for offshore station keeping. Fibre ropes for stationkeeping can be manufactured from different rope materials. This document provides general requirements applicable to all types of ropemaking materials. The subsequent parts of the ISO 18692 series provide the specific requirements for each rope core material (as quoted in the title of each part) that are not addressed within this document.

This document establishes a designation system of recycled carbon fibres, which can be used as the basis for specification. This designation system is applicable to recycled carbon fibres used for polymer composites. The types of recycled carbon fibres are differentiated by a designation system based on appropriate levels of the designatory properties: tensile modulus of elasticity. tensile strength. NOTE One to five designatory property(s) that differentiate recycled carbon fibre types from each other is (are) assigned.

This document provides information about optimizations for encoders and receiving systems for conducting machine analysis tasks on coded video content. It provides a concept-level overview of recent practices and provides comments on technical aspects and cautions to be taken when interpreting the results. This document describes technologies that have recently been studied and have demonstrated benefits to coding efficiency for some machine analysis tasks.

This document establishes a framework for the implementation of a sharing economy. It specifies requirements for and gives guidance on the operational economic, social, environmental, legal and other considerations and factors associated with implementation of sharing economy applications and approaches in sharing economy contexts. This document is applicable to all actors participating in the sharing economy ecosystem, including platform operators, providers, users and other stakeholders. This document is applicable to all types and sizes of organization (e.g. commercial enterprises, government agencies, not-for-profit organizations).

This document specifies the conditions for determining the tensile properties (including tensile modulus, Poisson’s ratio, strength, strain at maximum force and fracture strain) of ceramic matrix composite materials with continuous fibre reinforcement at room temperature. This document applies to all ceramic matrix composites with a continuous fibre reinforcement, including unidirectional (1D), bi-directional (2D), and multi-directional (xD, with x > 2), reinforcement, loaded along a principal axis of reinforcement. NOTE In most cases, ceramic matrix composites to be used at high temperature in air are coated with an antioxidation coating.

This document establishes required practices for the safe use of bridge and gantry cranes. It is intended to be used in conjunction with ISO 12480-1. This document applies to the bridge and gantry cranes as defined in ISO 4306-1 and ISO 4306-5.

This document specifies the requirements and test methods applicable to factory applied ceramic epoxy lining for ductile iron pipes conforming to ISO 2531, ISO 7186 and ISO 16631, excluding potable water, for operating temperature up to 50 °C.

This document specifies the determination of aldehydes and ketones content in polyether polyols and polymer polyols by high performance liquid chromatography (HPLC). This document is applicable to the determination of formaldehyde (HCHO), acetaldehyde (CH3CHO), acrolein (CH2=CHCHO) and acetone (CH3COCH3) in polyether polyols and polymer polyols.

This document specifies a method for sampling and handling earthworms from field soils as a prerequisite for using these animals as bioindicators (e.g. to assess the quality of a soil as a habitat for organisms). This document is applicable to all terrestrial biotopes in which earthworms occur. This document does not apply to semi-terrestrial soils (i.e. soils that are partly aquatic, such as bogs, beaches, marshes, stream margins) and it can be difficult to use under extreme climatic or geographical conditions (e.g. in high mountains). Methods for other soil organism groups, such as micro-arthropods and enchytraeids (mesofauna), are covered in other parts of the ISO 23611 series.

This document establishes a standardized notation with consistent design requirements for the results of business reporting, including written reports, presentations and dashboards. The notation specifies requirements for the visual appearance of: recurring visual aspects, such as the layout of charts, tables and text; their characteristics; the labelling of content. This document is applicable to business reporting regardless of an organization’s type, size, location or the nature of products and services delivered. For further guidance on accessibility requirements, refer to Web Content Accessibility Guidelines 2.2 and ISO/IEC 23859:2023.

This document specifies a method for the determination of carbon monoxide (CO) in the vapour phase of tobacco heating system according to ISO 5501-1, by a non-dispersive infrared analyser (NDIR). NOTE If tested products provide CO levels outside of the upper limit of the calibration range described in this document, then the calibration range described in ISO 22947 applies.

This document defines terms related to integration of life-cycle data for process plant installations. These terms are used by the parts in the ISO 15926 series. The following are outside the scope of this document: the reference data items that are contained in the reference data library, such as those covered in ISO/TS 15926-4:2024; the entities used in the data model, such as those covered in ISO 15926-2:2003.

This document describes methods for the determination of sulfur and chlorine content in solid biofuels and pyrogenic biocarbon and specifies two methods for decomposition of the fuel and different analytical techniques for the quantification of the elements in the decomposition solutions. The determination of other elements such as fluorine and bromine are also possible with the methods in this document, however performance data for these elements are not provided. The use of automatic equipment is also included in this document, provided that a validation is carried out as specified and that the performance characteristics are similar to those of the method described in this document.

This document specifies a general concept for provenance information of biological material and data, organizational roles, and requirements for provenance information management. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are: acquiring, collecting, processing, testing, analysing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); generating, collecting, analysing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); generating, collecting, analysing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizations in the domain); manufacturing devices or software for the aforementioned tasks or providing facilities for these tasks. This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). This document can be used by customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others for confirming or recognizing the competence of the aforementioned parties. This document does not apply to biological material and data used for medical diagnosis, treatment and therapy. NOTE 1 This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine. NOTE 2 International, national, or regional regulations, standards, or requirements can apply to specific topics covered in this document, e.g., for organizations handling human materials procured and used for diagnostic and treatment purposes.

This document specifies the methodology for applying precision estimates of a test method derived from the processes specified in ISO 4259-1. In particular, it specifies the procedures for setting the property specification limits based upon test method precision where the property is determined using a specific test method, and determines the specification conformance status when there are conflicting results between supplier and receiver. Other applications of this test method precision are briefly described in principle without the associated procedures. The procedures in this document have been designed specifically for petroleum and petroleum-related products, which are normally homogeneous. However, the procedures described in this document can also be applied to other types of homogeneous products. This document is not applicable to non-homogenous products.

This document specifies a procedure for determining the point resolution, called Scherzer resolution, of high-resolution transmission electron microscopes (HREM), which can visualize sample structure with sub-nanometre fineness. This document also specifies the measurement procedure of the real spherical aberration coefficient of the objective lens used. The procedure specified in this document for measuring the spherical aberration coefficient uses the dark rings that appear in the fast Fourier transform (FFT) pattern of HREM images of amorphous thin films, in which, at least three dark rings need to be observable near the Scherzer focus. Therefore, this document is applicable to HRTEMs equipped with a cold field emission gun (CFEG), Schottky emission gun (SEG) or thermal field emission gun (TFEG), or HREMs equipped with a thermionic emission gun (TEG) in which three or more dark rings can be clearly observed in the FFT pattern. This document does not treat the information limits, lattice resolution and STEM resolution. In addition, this document is not applicable to Cs-corrected TEM.

This document defines general technical terms used in many non-destructive testing disciplines.

This document specifies a test method for the determination of heating performance of wearable heating e-textile products. Wearable heating textile products are made of e-textile parts including a portable battery for electric heating and conventional textile parts for garments. This document includes the test procedure for the heating temperature and power consumption of wearable heating garments such as jackets, vests, etc. Heating gloves and footwear are excluded. The safety and security of heating products are excluded, as the information on thermal safety limits for heating products is addressed in IEC 60335-2-17 and IEC 62368‑1. The performance and safety of the portable battery are also excluded.

This document specifies the methodology for the design, planning, and execution of an interlaboratory study (ILS) and calculation of precision estimates of a test method specified by the study. In particular: it defines the relevant statistical terms, it specifies the procedures to be adopted in the planning and execution of an ILS to determine the precision of a test method, and it specifies the method of calculating the precision from the results of such a study. The procedures in this document have been designed specifically for petroleum and petroleum related products, which are normally considered as homogeneous. However, the procedures described in this document can also be applied to other types of homogeneous products.

This document presents an analysis of a test method and procedures for predicting print image quality for prints from high-speed inkjet printing systems. Results from an initial set of tests are reported. Based on this method, a set of paper properties and their ISO related standards is given, in addition to those presented in ISO 15397.

This document provides the specifications, requirements and test methods for non-petroleum-based fluids used in road-vehicle hydraulic brake and clutch systems that are designed for use with such fluids and equipped with seals, cups or double-lipped type gland seals made of styrene-butadiene rubber (SBR) and ethylene-propylene elastomer (EPDM).

This document is applicable to aseptically processed or terminally sterilized finished prefilled syringes (intended for single use only) based on syringe barrel components addressed in ISO 11040-4 or ISO 11040-6, together with a plunger stopper (sealing the back end) based on components addressed in ISO 11040-5 and a front end closure for parenteral preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods. Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent-containing syringes that have been emptied for reconstitution and in which the reconstituted injectable product has been aspirated after reconstitution) are excluded from the scope of this document. NOTE 1 This document can also be used as a guidance for other types, designs and/or sizes of finished prefilled syringes, for example dual chamber prefilled syringes. NOTE 2 For finished prefilled syringes that are used in needle-based injection systems, see also ISO 11608 (all parts). NOTE 3 Attention is drawn to applicable national or regional regulations and pharmacopoeias, such as Ph.Eur. [2], USP [3] or JP [4]. NOTE 4 Finished prefilled syringes for parenteral preparations which are medical devices or which, according to the principal mode of action of the product (i.e. the means by which the product achieves its principal intended action), are borderline between medical devices and medicinal products fall within the scope of this document, even if they are not always regulated as medicinal products.

This document provides the workflow and technical requirements for perceiving, evaluating and avoiding collisions among orbiting objects, data requirements for these tasks, identifies techniques that can be used to estimate either the probability or the consequence of collisions, or both, and provides requirements and guidance for executing collision avoidance manoeuvres.

This document specifies guidelines and requirements for the creation and use of intelligent transport system (ITS) station facilities layer service "message sets" (ITS-MsgSets). This includes specification of the basic structure of ITS-MsgSets, the creation of a message as a concatenation of messages from ITS-MsgSets, and the reception of respective messages.

This document specifies a system for aquaculture effluent reduction and discharge management. It includes principles, methods and guidance. This document is applicable to closed and semi-closed aquaculture systems in seawater and freshwater, aiming at reducing effluents and managing discharge and their impacts on receiving environments. This document does not apply to open aquaculture.

This document outlines key factors affecting machine learning model training efficiency and presents corresponding optimization approaches. It provides guidance for AI providers and producers through a structured set of characteristics and related optimizations to improve training efficiency. This information can support the evaluation and comparison of various ML training strategies. This document does not specify any training accelerating mechanisms provided and implemented within machine learning computing device described in ISO/IEC TR 17903.

This document specifies data link independent requirements of diagnostic communication services. These allow a diagnostic tester (client) to control diagnostic functions in an in-vehicle electronic control unit (ECU, server) such as an electronic fuel injection, automatic gearbox, anti-lock braking system, etc. connected to a serial data link embedded in a road vehicle. This document specifies diagnostic communication services, which allow the diagnostic tester (client) to stop or to resume non-diagnostic message transmission, to read vehicle identification data and real-time sensor data, read and clear diagnostic information, control actuators, start/stop routines, and many more functions to assist in diagnosing the vehicle's electronic systems. This document does not apply to non-diagnostic message transmission on the vehicle's communication data link between two electronic control units. This document does not restrict an in-vehicle on-board tester (client) implementation in an ECU/server in order to utilize the diagnostic communication services on the vehicle's communication data link to perform bidirectional diagnostic data exchange. This document does not specify any implementation requirements.