Professional technical supervision of corrosion control life cycle engineering

This proposal carries out effective supervision and inspection on the measures related to corrosion control in various elements (corrosion source, material, technology, design, research and development, manufacturing, construction and installation, storage and transportation, commissioning and acceptance, operation, maintenance and repair, life extension and scrapping) of corrosion control engineering, and eventually formulates a set of third-party supervision procedures which meet the requirements of integration, systematization, mutual coordination and optimization of the main life cycle.
It is applicable to the technical supervision of all types of corrosion control engineering programme in the whole life cycle.


General Requirements for Cathodic Protection Engineering Life Cycle.

This standard specifies the general requirements for all elements in the whole chain of cathodic protection engineering life cycle that affect the protected object.
This standard applies to the life cycle management of various cathodic protection engineering.


Workplace atmospheres — Determination of inorganic acids by ion chromatography — Part 2: Volatile acids, except hydrofluoric acid (hydrochloric acid, hydrobromic acid and nitric acid)

Air des lieux de travail — Détermination des acides inorganiques par chromatographie ionique — Partie 2: Acides volatils, sauf acide fluorhydrique (acide chlorhydrique, acide bromhydrique et acide nitrique)

This document specifies a method for the determination of the time-weighted average mass concentration of hydrogen chloride (HCl) gas and hydrochloric acid mist, hydrogen bromide (HBr) vapour and hydrobromic acid mist and nitric acid (HNO3) vapour and mist in workplace air by collection on an alkali-impregnated quartz fibre filter and analysis by ion chromatography.

For mist sampling, this method is applicable to the personal sampling of the inhalable fraction of airborne particles as defined in ISO 7708 and to static (area) sampling.


This standard specifies the General Requirements for Corrosion-resistant Petrolatum Composite Steel Structure Engineering Life Cycle.
This standard applies to the whole process of life cycle of corrosion-resistant Petrolatum Composite Steel Structure Engineering.


Corrosion Control Engineering Life Cycle-- Vocabulary

This document establishes the terminology related to the Corrosion Control Engineering Life Cycle series of standards, including terms related to basics,terms related to profession, and terms related to industries.
It is applicable to various types of corrosion control engineering projects.


Oil and gas industries including lower carbon energy — Offshore structures — Part 8: Marine soil investigations

Industries du pétrole et du gaz y compris les énergies à faible teneur en carbone — Structures en mer — Partie 8: Investigations des sols en mer

This document specifies requirements and provides recommendations and guidelines for marine soil investigations regarding:

a)    objectives, planning and execution of marine soil investigations;

b)    deployment of investigation equipment;

c)    drilling and logging;

d)    in situ testing;

e)    sampling;

f)     laboratory testing;

g)    reporting.

Although this document focuses on investigations of soil, it also provides guidance, with less detail, for investigations of chalk, calcareous soils, cemented soils and weak rock.

Foundation design is not covered by this document.

NOTE 1    ISO 19901‑4 and the respective design standards covering foundation design for the specific types of offshore structures to meet the requirements of application specific standards are given on the ISO website.

The results from marine geophysical investigations are, when available and where appropriate, used for planning, optimization and interpretation of marine soil investigations.

This document neither covers the planning, execution and interpretation of marine geophysical investigations nor the planning and scope of geohazard assessment studies, only the corresponding marine soil investigations aspects thereof.

NOTE 2    ISO 19901-10 covers the planning, execution and interpretation of marine geophysical investigations.

This document specifies requirements and provides guidance for obtaining measured values and derived values. This document excludes requirements for determination of design values and representative values. Limited guidance is provided in 11.3 related to data interpretation.

This document is intended for clients, soil investigation contractors, designers, installation contractors, geotechnical laboratories and public and regulatory authorities concerned with marine soil investigations for any type of offshore structures, or geohazard assessment studies.


Road vehicles — Safety and artificial intelligence

Véhicules routiers — Sécurité et intelligence artificielle

This document applies to safety-related systems that include one or more electrical and/or electronic (E/E) systems that use AI technology and that is installed in series production road vehicles, excluding mopeds. It does not address unique E/E systems in special vehicles, such as E/E systems designed for drivers with disabilities.

This document addresses the risk of undesired safety-related behaviour at the vehicle level due to output insufficiencies, systematic errors and random hardware errors of AI elements within the vehicle. This includes interactions with AI elements that are not part of the vehicle itself but that can have a direct or indirect impact on vehicle safety.

EXAMPLE 1         Examples of AI elements within the vehicle include the trained AI model and AI system.

EXAMPLE 2         Direct impact on safety can be due to object detection by elements external to the vehicle.

EXAMPLE 3         Indirect impact on safety can be due to field monitoring by elements external to the vehicle.

The development of AI elements that are not part of the vehicle is not within the scope of this document. These elements can conform to domain-specific safety guidance. This document can be used as a reference where such domain-specific guidance does not exist.

This document describes safety-related properties of AI systems that can be used to construct a convincing safety assurance claim for the absence of unreasonable risk.

This document does not provide specific guidelines for software tools that use AI methods.

This document focuses primarily on a subclass of AI methods defined as machine learning (ML). Although it covers the principles of established and well-understood classes of ML, it does not focus on the details of any specific AI methods e.g. deep neural networks.


Plastics — X-Ray Diffraction — Part 1: General Principles

This document specifies a number of general aspects of X-Ray diffractometry in plastic characterization, such as the principle and the apparatus, sampling, calibration and general aspects of the procedure and test report common to all following parts. This document is applicable to plastics characterization methods using small angle X-ray scattering, wide angel X-ray scattering, 2D and 3D X-ray pattern analysis, etc. This document is not applicable to plastics characterization methods using X-ray source from synchrotron radiation. Details on performing specific methods are given in subsequent parts of this series of ISO standards.


Preparation of steel substrates before application of paints and related products — Part 1: Test Method for determining emission factors for Recyclable Encapsulated Abrasive Media

Create a procedure that can quantify the amount of dust (emissions) created by an abrasive during the abrasive blasting process, inclusive of the abrasive, coating, and substrate removed.


Recreational diving services — Requirements for rebreather diver training — Decompression diving to 60 m

Services relatifs à la plongée de loisirs — Exigences concernant la formation des plongeurs à l’utilisation des recycleurs — Plongée avec décompression jusqu’à 60 m

This document specifies requirements for rebreather diver training programmes which provide the competencies required to perform dives to 60 m with a rebreather, using a breathing mixture containing helium and requiring mandatory decompression stops.

This document specifies evaluation criteria for these competencies.

This document specifies the requirements under which training is provided, in addition to the general requirements for recreational diving service provision in accordance with ISO 24803.


Recreational diving services — Requirements for rebreather diver training — Decompression diving to 100 m

Services relatifs à la plongée de loisirs — Exigences concernant la formation des plongeurs à l’utilisation des recycleurs — Plongée avec décompression jusqu’à 100 m

This document specifies requirements for rebreather diver training programmes which provide the competencies required to perform dives to 100 m with a rebreather using a breathing mixture containing helium and requiring mandatory decompression stops.

This document specifies evaluation criteria for these competencies.

This document specifies the requirements under which training is provided, in addition to the general requirements for recreational diving service provision in accordance with ISO 24803.


Requirements for the training of scientific divers — Part 1: Scientific divers

Exigences concernant la formation des plongeurs scientifiques — Partie 1: Plongeurs scientifiques

This document specifies minimum requirements for the training of scientific divers to undertake scientific diving.

This document specifies evaluation criteria for these competencies.

This document specifies the requirements under which training is provided, in addition to the general requirements for recreational diving service provision according to ISO 24803.


Requirements for the training of scientific divers — Part 2: Advanced scientific divers

Exigences concernant la formation des plongeurs scientifiques — Partie 2: Plongeurs scientifiques confirmés

This document specifies minimum requirements for the training of advanced scientific divers to undertake advanced scientific diving.

This document specifies evaluation criteria for these competencies.

This document specifies the requirements under which training is provided, in addition to the general requirements for recreational diving service provision in accordance with ISO 24803.


Requirements for the training of scientific divers — Part 3: Scientific diving project leader

Exigences concernant la formation des plongeurs scientifiques — Partie 3: Responsable de projet de plongée scientifique

This document specifies minimum requirements for the training of scientific diving project leaders.

This document specifies evaluation criteria for scientific diving project leaders.

This document specifies the requirements under which training is provided, in addition to the general requirements for recreational diving service provision in accordance with ISO 24803.


Plastics — X-Ray Diffraction — Part 2: Determination of Degree of Crystallinity

This document specifies a method for the determination of the degree of crystallinity of plastics by means of X-Ray Diffraction. This document is applicable to plastic specimens prepared from powder, granule or finished parts made by moulding and extrusion. This document does not apply to filled plastics and/or the copolymers that do not comply with the two-phase model.


Plastics — X-Ray Diffraction — Part 3: Characterization of the crystallographic texture using pole figure

This proposal provides a test method which covers the use of the X-ray diffractometerto characterize the texture of plastics by using pole figures.It is suitable for the texture analysis of semicrystalline polymer products such as polyethylene, polypropylene, etc.


Plastics — Determination of residual peroxide — Gas chromatography method

Plastiques — Détermination du peroxyde résiduel — Méthode par chromatographie en phase gazeuse

This document specifies a method for determination of di-tert-butyl peroxide (DTBP) and 2, 5-Dimethyl-2, 5-di (tert-butylperoxy) hexane (DBPH) in plastic by using gas chromatography.

This document is applicable to the determination of the content of residual peroxides in plastics and their products, which using the peroxides as a degradation agent or crosslinking agent during plastic processing, or as an additive during polymerization, thereby remaining in degraded polypropylene, crosslinked polyethylene, polystyrene and other plastics.


Information technology — Dynamic adaptive streaming over HTTP (DASH) — Part 1: Media presentation description and segment formats

Technologies de l'information — Diffusion en flux adaptatif dynamique sur HTTP (DASH) — Partie 1: Description de la présentation et formats de remise des médias

This document primarily specifies formats for the Media Presentation Description and Segments for dynamic adaptive streaming delivery of MPEG media over HTTP. It is applicable to streaming services over the Internet.


Information technology — Dynamic adaptive streaming over HTTP (DASH) — Part 1: Media presentation description and segment formats — Amendment 1: Media presentation insertion event, nonlinear playback and other extensions

Technologies de l'information — Diffusion en flux adaptatif dynamique sur HTTP (DASH) — Partie 1: Description de la présentation et formats de remise des médias — Amendement 1: Titre manque


Equipment for crop protection — Knapsack sprayers — Part 3: Inspection of knapsack sprayers in use

Matériel de protection des cultures — Pulvérisateurs à dos — Partie 3: Contrôle des pulvérisateurs portables à dos en service

This document specifies the requirements and test methods for inspection of the use of knapsack sprayers carried on the back or shoulder of the operator for use with plant protection products (PPPs).

The requirements relate mainly to the condition of the sprayer with respect to its potential risk to the operator and the environment and its performance to achieve good application.

This document is applicable to lever-operated knapsack sprayers, knapsack compression sprayers and knapsack sprayers driven by an engine or electric motor using hydraulic pressure atomisation of the spray liquid, intended for use primarily in agriculture, forestry and horticulture, with a nominal volume of more than 6,0 l.

It does not apply to

—    knapsack combustion engine-driven air-blast sprayers, which are covered in ISO 28139:2019/Amd 1:2024,

—    controlled droplet application equipment utilizing rotary atomisers, or

—    portable application equipment for spatial application (such as foggers).


Plastics — Determination of residual peroxide — Part 2: Gas chromatography-mass spectrometry (GC-MS)

This document specifies a method for the determination of the residual peroxide in plastic by using gas chromatography-mass spectrometry (GC-MS).
The document is applicable to peroxide-degraded polypropylene and their products. The limit of quantification for DTBP and DBPH is 1 mg/kg.
NOTE    This method is also suitable for the determination of the residual peroxide in other plastics, such as polyethylene, polybutene, etc.


Preparation of steel substrates before application of paints and related products — Specifications for non-metallic blast-cleaning abrasives — Part 11: Volcanic lava

Préparation des subjectiles d'acier avant application de peintures et de produits assimilés — Spécifications pour abrasifs non métalliques destinés à la préparation par projection — Partie 11: Lave volcanique

This document specifies requirements for volcanic lava, as supplied for blast-cleaning processes. It specifies ranges of particle sizes and values for apparent density, Mohs hardness, moisture content, conductivity of aqueous extract and water-soluble chlorides.

The requirements specified in this document apply to abrasives supplied in “new” condition only. They do not apply to abrasives either during or after use.

Test methods for non-metallic blast-cleaning abrasives are given in the various parts of ISO 11127 series.

NOTE       Although this document has been developed specifically to meet requirements for the preparation of steelwork, the properties specified will generally be appropriate for use when preparing other material surfaces, or components, using blast-cleaning techniques. These techniques are described in ISO 8504-2.


Information technology — Guidance for the use of database language SQL — Part 9: Online analytic processing (OLAP) capabilities (Guide/OLAP)

Langages de bases de données utilisés dans les technologies de l'information — Recommandations pour l'utilisation du langage de base de données SQL — Partie 9: Capacités de traitement analytique en ligne (OLAP), (Guide/OLAP)

This document discusses the syntax and semantics for including online analytic processing (OLAP) capabilities
in SQL, as defined in ISO/IEC 9075-2.
It discusses the following features regarding OLAP capabilities of the SQL language:
— Feature T611, “Elementary OLAP operations”,
— Feature T612, “Advanced OLAP operations”,
— Feature T614, “NTILE function”,
— Feature T615, “LEAD and LAG functions”,
— Feature T616, “Null treatment option for LEAD and LAG functions”,
— Feature T617, “FIRST_VALUE and LAST_VALUE functions”,
— Feature T618, “NTH_VALUE function”,
— Feature T619, “Nested window functions”,
— Feature T620, “WINDOW clause: GROUPS option”,
— Feature T621, “Enhanced numeric functions”


Preparation of steel substrates before application of paints and related products — Surface Preparation Methods — Part 6: Laser Cleaning

This document specifies laser cleaning methods for the preparation of steel surfaces before coating with paints and related products. It provides information on the effectiveness of the individual methods and their fields of application. It describes the equipment to be used and the procedure to be followed.
ISO 8504 series is applicable to new and corroded steel surfaces and to steel surfaces that are uncoated or have been previously coated with paints and related products.


Paints and varnishes — Coating systems for wind-turbine rotor blades — Part 7: Determination and evaluation of resistance to hail

Peintures et vernis — Matériaux de revêtement pour pales de turbines éoliennes — Partie 7: Détermination et évaluation de la résistance à la grêle

This document describes test procedures to assess the hail resistance properties of rotor blade coating systems using ice particles.


Paints and varnishes — Coating systems for wind-turbine rotor blades — Part 8: Determination and evaluation of resistance to soiling


Paints and varnishes — Determination of density — Part 1: Pycnometer method

Peintures et vernis — Détermination de la masse volumique — Partie 1: Méthode pycnométrique

This document specifies a method for determining the density of paints, varnishes and related products using a metal or Gay-Lussac pycnometer.

The method is limited to materials of low or medium viscosity at the temperature of test. The Hubbard pycnometer (see ISO 3507) can be used for highly viscous materials.


Paints and varnishes — Evaluation of quantity and size of defects, and of intensity of uniform changes in appearance — Part 3: Assessment of degree of rusting

Peintures et vernis — Évaluation de la quantité et de la dimension des défauts, et de l’intensité des changements uniformes d’aspect — Partie 3: Évaluation du degré d’enrouillement

This document specifies methods for assessing the degree of rusting of surfaces coated with paints and varnishes (organic coatings), and metallic coating plus an organic coating (duplex system), by comparison with pictorial standards.

The pictorial standards provided in this document show surfaces which have deteriorated to different degrees by a combination of rust broken through the coating and visible under-rusting.

The assessment of the degree of rusting in this document is only an estimation of the affected area on specimen. Edges are not included.


Paints and varnishes — Evaluation of quantity and size of defects, and of intensity of uniform changes in appearance — Part 5: Assessment of degree of flaking

Peintures et vernis — Évaluation de la quantité et de la dimension des défauts, et de l’intensité des changements uniformes d’aspect — Partie 5: Évaluation du degré d’écaillage

This document specifies a method for assessing the degree of flaking of coatings by comparison with pictorial standards.

ISO 4628-1 specifies the system used for designating the quantity and size of defects and the intensity of changes in appearance of coatings. It also outlines the general principles of the system. This system is intended to be used, in particular, for defects caused by ageing and weathering, and for uniform changes such as colour changes, for example yellowing.


Paints and varnishes — Evaluation of quantity and size of defects, and of intensity of uniform changes in appearance — Part 10: Assessment of degree of filiform corrosion

Peintures et vernis — Évaluation de la quantité et de la dimension des défauts, et de l’intensité des changements uniformes d’aspect — Partie 10: Évaluation du degré de corrosion filiforme

This document specifies a method for assessing the amount of filiform corrosion developed from a scribed mark by measuring the length of the longest filament L and the most frequent length M of filaments.

Pictorial examples provided in Annex A of this document illustrate different ratings for the degree of filiform corrosion. A comparison of the test panels with the 12 pictures in Annex A does not supersede the obligatory numerical assessment (method 1 or 2).

ISO 4628-1 defines a system used for designating the quantity and size of defects and the intensity of uniform changes in appearance of coatings and outlines the general principles of the system. This system is intended to be used, in particular, for defects caused by ageing and weathering, and for uniform changes such as colour changes, for example yellowing.


Paints and varnishes — Determination of resistance to abrasion — Part 1: Method with abrasive-paper covered wheels and rotating test specimen

Peintures et vernis — Détermination de la résistance à l'abrasion — Partie 1: Méthode utilisant des roues revêtues de papier abrasif et une éprouvette rotative

This document specifies a method for determining the resistance to abrasion of coatings, for which two loaded, freely rotatable but eccentrically arranged abrasive-paper covered wheels affect the coating of the rotating test specimen.


Paints and varnishes — Determination of resistance to abrasion — Part 2: Method with abrasive rubber wheels and rotating test specimen

Peintures et vernis — Détermination de la résistance à l'abrasion — Partie 2: Méthode utilisant des roues abrasives en caoutchouc et une éprouvette rotative

This document specifies a method for determining the resistance to abrasion of coatings, for which two loaded, freely rotatable but eccentrically arranged abrasive rubber wheels affect the coating of the rotating test specimen.


Paints and varnishes — Determination of resistance to abrasion — Part 3: Method with abrasive-paper covered wheel and linearly reciprocating test specimen

Peintures et vernis — Détermination de la résistance à l'abrasion — Partie 3: Méthode utilisant une roue revêtue de papier abrasif et une éprouvette animée d'un mouvement de va-et-vient linéaire

This document specifies a method for determining the resistance to abrasion of coatings, for which a loaded, rigid abrasive-paper covered wheel affects the coating of the linearly reciprocating test specimen.


Paints and varnishes — Determination of scratch resistance — Part 1: Constant-loading method

Peintures et vernis — Détermination de la résistance à la rayure — Partie 1: Méthode à charge constante

This document specifies a test method for determining, under defined conditions, the resistance of a single coating or a multi-coat system of paint, varnish or related product to penetration, by scratching with a scratch stylus loaded with a specified load. The stylus penetrates to the substrate, except in the case of a multi-coat system, in which case the stylus can penetrate either to the substrate or to an intermediate coat.

The method specified can be carried out:

a)    either as a “pass/fail” test, by testing with a single specified load applied to the stylus to assess conformity with a particular specification; or

b)    as an assessment test by applying increasing loads to the stylus to determine the minimum load at which the coating is penetrated.

NOTE      Neither this document nor ISO 1518-2 specifies a method using a curved stylus, which is specified in ISO 12137. The choice between the three methods depends on the particular practical problem.


Binders for paints and varnishes — Epoxy resins — General methods of test

Liants pour peintures et vernis — Résines époxydiques — Méthodes générales d'essai

This document specifies general methods of test for epoxy resins for use in paints, varnishes and similar products. It is also applicable to those solutions made from epoxy resins that are intended for use as binders for paints and varnishes.

The test methods described in this document are not intended for epoxy esters.


Plain bearings — Water-lubricated plain bearing materials

Paliers lisses — Matériaux de paliers lisses lubrifiés à l'eau

This document specifies requirements for the selection and use of water-lubricated plain bearing materials used in different equipment and plants under various lubrication conditions, such as

—     fluid-film lubrication condition,

—     mixed lubrication condition, and

—     condition comprising a non-lubrication condition which shifts to a fluid-film lubrication condition.

In addition, this document also specifies requirements for mating (shaft) material, the lubrication method and for items to consider during the design of water-lubricated plain bearing materials.

The water used as a lubricant is pure water, tap water, river water or seawater. This document does not apply to the water solution of chemicals, refrigerants, liquid fuels, etc.


Photography — Processed photographic colour films and paper prints — Methods for measuring image stability

Photographie — Films et papiers photographiques couleur traités — Méthodes de mesure de la stabilité de l'image

This document describes test methods for determining the long-term dark storage stability of colour photographic images and the colour stability of such images when subjected to certain illuminants at specified temperatures and relative humidities.

This document is applicable to colour photographic images made with traditional, continuous-tone photographic materials with images formed with dyes. These images are generated with chromogenic, silver dye-bleach, dye transfer, and dye-diffusion-transfer instant systems. The tests have not been verified for evaluating the stability of colour images produced with dry- and liquid-toner electrophotography, thermal dye transfer (sometimes called dye sublimation), ink jet, pigment-gelatin systems, offset lithography, gravure and related colour imaging systems. If these reflection print materials, including silver halide (chromogenic), are digitally printed, refer to ISO 18936, ISO 18941, ISO 18946, and ISO 18949 for dark stability tests, and the ISO 18937 series for light stability tests.

This document does not include test procedures for the physical stability of images, supports or binder materials. However, it is recognized that in some instances, physical degradation such as support embrittlement, emulsion cracking or delamination of an image layer from its support, rather than image stability, will determine the useful life of a colour film or print material.


Industrial trucks — Verification of stability — Part 16: Pedestrian-propelled trucks

Chariots de manutention — Vérification de la stabilité — Partie 16: Chariots à conducteur à propulsion manuelle

This document specifies tests for verifying the stability of pedestrian-propelled trucks.

It is applicable to:

—     stacker, pallet and pallet stacker trucks with capacities not exceeding 1 000 kg, with manual or battery-powered lift;

—     scissor-lift pallet trucks with lift heights up to 1 000 mm and rated capacity up to 1 500 kg, with manual or battery-powered lift;

—     platform trucks.

It also applies to trucks operating under the same conditions when equipped with load-handling attachments.

It is not applicable to trucks with retractable devices such as a retractable mast or retractable fork carrier.


Quality requirements for fusion welding of metallic materials — Part 6: Guidelines on implementing the ISO 3834 series

Exigences de qualité en soudage par fusion des matériaux métalliques — Partie 6: Lignes directrices pour la mise en application de la série ISO 3834

This document gives guidelines for the implementation of requirements given in the other parts of the ISO 3834 series. It is intended to help users select the appropriate part of the ISO 3834 series. It is expected that users will already be familiar with the ISO 3834 series as a whole.

This document does not provide additional requirements to those in ISO 3834-1 to ISO 3834-5.


Information technology — Coding of audio-visual objects — Part 15: Carriage of network abstraction layer (NAL) unit structured video in the ISO base media file format

Technologies de l'information — Codage des objets audiovisuels — Partie 15: Transport de vidéo structurée en unités NAL sur la couche réseau au format ISO de base pour les fichiers médias

This document specifies the storage format for streams of video that is structured as NAL Units, such as AVC (ISO/IEC 14496-10) and HEVC (ISO/IEC 23008-2) video streams. In addition, Annex E specifies parameters and sub-parameters applying when sample entries specified in this document are used as the 'codecs' parameter of a MIME type, as specified in IETF RFC 6381.


Information technology — Coding of audio-visual objects — Part 15: Carriage of network abstraction layer (NAL) unit structured video in the ISO base media file format — Amendment 1: Support for LCEVC

Technologies de l'information — Codage des objets audiovisuels — Partie 15: Transport de vidéo structurée en unités NAL sur la couche réseau au format ISO de base pour les fichiers médias — Amendement 1: Support pour LCEVC


Microscopes — Designation of microscope objectives — Part 4: Polarization characteristics

Microscopes — Désignation des objectifs de microscope — Partie 4: Caractéristiques de polarisation

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.


Metallic materials — Torsion test at room temperature

Matériaux métalliques — Essai de torsion à température ambiante

This document specifies the method for torsion test at room temperature of metallic materials. The tests are conducted at room temperature to determine torsional properties.


Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment — Amendment 1

Appareils électromédicaux — Partie 2-77: Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés — Amendement 1


Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation — Amendment 1

Appareils électromédicaux — Partie 2-78: Exigences particulières pour la sécurité de base et les performances essentielles des robots médicaux dédiés à la rééducation, l'évaluation, la compensation ou l'atténuation — Amendement 1


Characterization of the performance of illuminance meters and luminance meters

Caractérisation des performances des luxmètres et des luminancemètres

ISO/CIE 19476:2014 is applicable to illuminance and luminance meters. It defines quality indices characterizing the performance of such devices in a general lighting measurement situation, as well as measurement procedures for the individual indices and standard calibration conditions.

Measurements of illuminance or luminance and their accuracy are influenced by various parameters, such as operational conditions, properties of light sources, as well as characteristics of the applied photometers. The characteristics of these photometers alone do not allow the determination of the measurement uncertainty for a specific measurement task. Nevertheless, it is generally true that instruments with "better" characteristics in most cases produce smaller uncertainties than instruments with "worse" properties.


Traditional Chinese medicine — General requirements of moxibustion devices

Médecine traditionnelle chinoise — Exigences générales concernant les dispositifs de moxibustion

This document specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices.

It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage.

This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.


Fine ceramics (advanced ceramics, advanced technical ceramics) — Test methods for evaluating the stability of fine ceramic and fine ceramic/metal multilayer coatings for the exposure to corrosive environments

This document specifies the requirements for the laminated-type reference mirrors consisting of an Ag or Al metal thin film layer used for relative measurements of regular spectral reflectance of fine ceramic coatings day-to-day in laboratory room or quality assurance rooms.


Fine ceramics (advanced ceramics, advanced technical ceramics) — Laminated-type reference mirrors used for measuring regular spectral reflectance of fine ceramic coatings


Road vehicles — Functional safety — Use of pre-existing software architectural elements

Véhicules routiers — Sécurité fonctionnelle — Utilisation d'éléments d'architecture logicielle préexistants

This document describes a framework for functional safety to enable the use of pre-existing software architectural elements not originally developed in accordance with the ISO 26262:2018 series, but intended to be integrated into safety-related embedded software conformant with the ISO 26262:2018 series by:

—     determining relevant criteria when using the pre-existing software architectural element as a safety-related element of safety-related embedded software;

—     determining relevant criteria inherent to the pre-existing software architectural element, e.g. needs for external safety mechanisms to detect and control failures caused by the pre-existing software architectural element;

—     providing suitable evidence and arguments for use of the pre-existing software architectural element that can include applicable procedures, techniques and safety measures;

—     supporting the fulfilment of software safety requirements when using the pre-existing software architectural element as a safety-related element of safety-related embedded software;

—     supporting the integration of the pre-existing software architectural element as a safety-related element of safety-related embedded software.


Fire detection and alarm systems — Part 29: Video fire detectors

Systèmes de détection et d'alarme d'incendie — Partie 29: Détecteurs de fumée vidéo

This document specifies requirements, test methods and performance criteria for video fire detectors (VFDs), which operate in the visible spectrum, for use in fire detection and alarm systems installed in and around buildings (see ISO 7240-1). For the testing of other types of VFD working on different principles, this document can be used only for guidance.

Detectors developed for the protection of specific risks that incorporate special characteristics (including additional features or enhanced functionality for which this document does not define a test or assessment method) are beyond the scope of this document.


Paints and varnishes — Pendulum damping test

Peintures et vernis — Essai d'amortissement du pendule

This document specifies two methods of carrying out a pendulum damping test on a coating of paint, varnish or other related products. It is applicable to single coatings and to multicoat systems.


Equipment for crop protection — Knapsack combustion engine-driven airblast sprayers — Safety and environmental requirements and test methods — Amendment 1

Matériel de protection des cultures — Atomiseurs portés à dos motorisés — Exigences de sécurité et environnementales et méthodes d'essai — Amendement 1


Paints and varnishes — Pull-off test for adhesion

This document specifies three methods for determining the adhesion by carrying out a pull-off test on a single coating or a multi-coat system of paint, varnish or related product.

These methods include:

—    method A: using two dollies, suitable for testing both rigid and deformable substrates;

—    method B: testing from one side only, using a single dolly, suitable for rigid substrates only;

—    method C: using dollies, one as a painted substrate.

These test methods have been found useful in comparing the adhesion behaviour of different coatings. It is most useful in providing relative ratings for a series of coated panels exhibiting significant differences in adhesion.

The test can be applied using a wide range of substrates. Different procedures are given according to whether the substrate is deformable, e.g. thin metal, plastics and wood, or rigid, e.g. thick concrete and metal plates. To avoid distortion of the substrate during the tensile test, it is common to use a sandwich construction. For example, for special purposes, the coating can be applied directly to the face of a test dolly.


Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions

Stérilisation des produits de santé — Vocabulaire des termes utilisés dans les normes de procédés de stérilisation et les équipements connexes — Amendement 1: Termes et définitions modifiés et supplémentaires


Technical product documentation — Digital product definition data practices

Documentation technique de produits — Pratiques pour les données numériques de la définition d’un produit

This document specifies requirements for the preparation, revision and presentation of digital product definition data, hereafter referred to as data sets, complementing existing standards. It supports two methods of application: 3D model-only and 3D model with 2D drawing in digital format. The structure of this document presents requirements common to both methods followed by clauses providing for any essential, differing requirements for each method. Additionally, its use in conjunction with computer-aided design (CAD) systems can assist in the progression towards improved modelling and annotation practices for CAD and engineering disciplines, as well as serving as a guideline for CAx software developers.

The actual definitions for the interpretation, in particular the ISO TPD and ISO GPS rules, are taken from the original definition standards, e.g. ISO 129-1 and ISO 1101.

When the term model is used in this document it applies to both design models and annotated models.


Mechanical pencils for technical drawings — Part 2: Black leads — Classification and dimensions

Porte-mines pour le dessin technique — Partie 2: Mines graphite — Classification et dimensions

This document specifies a classification and dimensions for black leads used for mechanical pencils for technical drawings.

Two types of black leads are available:

—    polymer leads (designated by the letter “P”);

—    ceramic leads (designated by the letter “C”).


Mechanical pencils for technical drawings — Part 3: Black leads — Bending strengths of HB leads

Porte-mines pour le dessin technique — Partie 3: Mines graphite — Résistance à la flexion des mines HB

This document specifies bending strengths and a test method for black leads of HB hardness degree used for mechanical pencils for technical drawings.


Technical product documentation (TPD) — General principles of representation — Part 2: Basic conventions for lines

Documentation technique de produits (TPD) — Principes généraux de représentation — Partie 2: Conventions de base pour les traits

This document establishes the types of lines used in technical drawings (e.g. diagrams, plans or maps), their designations and their configurations, as well as general rules for the draughting of lines. In addition, this document specifies general rules for the representation of leader and reference lines and their components as well as for the arrangement of instructions on or at leader lines in technical documents. Annexes have been provided for specific information on mechanical, construction and shipbuilding technical drawings.

For the purposes of this document the term “technical drawing” is interpreted in the broadest possible sense, encompassing the total package of documentation specifying the product (workpiece, subassembly, assembly).


Technical product documentation (TPD) — General principles of representation — Part 3: Views, sections and cuts

Documentation technique de produits (TPD) — Principes généraux de représentation — Partie 3: Vues, sections et coupes

This document specifies the general principles for presenting views, sections and cuts applicable to various kinds of technical drawings (e.g. mechanical, electrical, architectural, civil engineering), following the orthographic projection methods specified in ISO 5456-2. Views and sections for shipbuilding technical drawings are discussed in ISO 128-15. Views and sections for 3D models are discussed in ISO 16792.

Attention has also been given in this document to the requirements of reproduction, including microcopying in accordance with ISO 6428.


Explosive atmospheres — Part 49: Flame arresters — Performance requirements, test methods and limits for use

Atmosphères explosives — Partie 49: Arrête flammes — Exigences de performance, méthodes d’essai et limites d’utilisation

This document specifies the requirements for flame arresters that prevent flame transmission when explosive gas-air or vapour-air mixtures are present. It establishes uniform principles for the classification, basic construction and information for use, including the marking of flame arresters, and specifies test methods to verify the safety requirements and determine safe limits of use. This document is applicable to pressures ranging from 80 kPa to 160 kPa and temperatures ranging from -20 °C to +200 °C. This document does not apply to the following: - external safety-related measurement and control equipment that might be required to keep the operational conditions within the established safe limits; - flame arresters used for explosive mixtures of vapours and gases, which tend to self-decompose (for example, acetylene) or which are chemically unstable; - flame arresters used for carbon disulfide, due to its special properties; - flame arresters whose intended use is for mixtures other than gas-air or vapour-air mixtures (for example, higher oxygen-nitrogen ratio, chlorine as oxidant); - flame arrester test procedures for reciprocating internal combustion engines; - fast acting valves, extinguishing systems and other explosion isolating systems; - Flame arresters used in gas detectors (those being covered for example, by IEC 60079‑29‑1 and IEC 62990‑1). This edition cancels and replaces ISO 16852:2016, which has been technically revised. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to ISO 16852:2016: a) adaptation of the relevant IEC TC 31 requirements on standards; b) modification of the upper limit of the temperature range from 150 °C to 200 °C under the condition that T0 shall be not larger than 80 % of the auto ignition temperature of the gas-air-mixture; c) change of the term "explosion group" to "equipment group" due to editorial requirements in IEC/TC 31; d) clarification of the conditions and requirements for flame arresters whose intended operating conditions are outside the atmospheric conditions in 7.3.4 and 7.3.5; e) clarification of the requirements on the information for use in Clause 12 f) concerning the burn time; f) addition of a permission to the construction requirements both in 7.1 and 14.1 to substitute visual inspection by performing a flow test; g) addition of a flow chart for the evaluation of test results as Annex D


Railway infrastructure — Rail welding — Part 3: Gas pressure welding

Infrastructure ferroviaire — Soudage des rails — Partie 3: Soudage sous pression de gaz

This document corresponds to the subsequent part of ISO 23300-1 "General requirements and test methods for rail welding" and specifies the requirements on rail gas pressure welding, including the requirements for approval of a gas pressure welding process, laboratory tests, production test, contractor/welder, as well as the acceptance criteria of gas pressure welds in track.
In this document, 43kg/m – 75kg/m new flat bottomed rails of the same profiles and same steel grades are the subject of welding.
This document is restricted to butt welding for connecting rail ends. This document does not cover safety regulation of welding operation.
Compliance with the requirements of this standard does not of itself ensure the suitability of a welding process for specific conditions of track and traffic. This standard does not cover welds made between different rail sections, differently worn rails and different rail grades.


Ophthalmic optics — Spectacle frames — Method for the simulation of wear and detection of nickel release from metal and combination spectacle frames

Optique ophtalmique — Montures de lunettes — Méthode de simulation de l'usure et de détection de la libération du nickel de montures de lunettes en métal et combinées

ISO/TS 24348:2014 specifies methods for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated metal and combination spectacle frames, and for detecting the release of nickel from those parts of metal and combination spectacle frames, whether coated or not, intended to come into direct and prolonged contact with the skin, in order to determine whether such parts release nickel at a rate greater than 0,5 µg/cm2/week.


Ophthalmic instruments — Optical coherence tomographs — Part 1: Optical coherence tomographs for the posterior segment of the human eye

Instruments ophtalmiques — Tomographe à cohérence optique — Partie 1: Tomographe à cohérence optique du segment postérieur de l'oeil humain

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.


Ophthalmic instruments — Optical coherence tomographs — Part 2: Optical coherence tomographs for the anterior segment of the human eye


Information technology — Universal coded character set (UCS) — Amendment 1: CJK Unified Ideographs Extension H, Vithkuqi, Old Uyghur, Cypro-Minoan, and other characters

Technologies de l'information — Jeu universel de caractères codés (JUC) — Amendement 1: Supplément H aux idéogrammes unifiés CJK, Vithkuqi, vieil-ouïghour, Chypro-minoen, et autres caractères


Information technology — International string ordering and comparison — Method for comparing character strings and description of the common template tailorable ordering — Amendment 1

Technologies de l'information — Classement international et comparaison de chaînes de caractères — Méthode de comparaison de chaînes de caractères et description du modèle commun et adaptable d'ordre de classement — Amendement 1


Graphical symbols for diagrams — Part 2: Graphical symbols

Symboles graphiques pour schémas — Partie 2: Symboles graphiques

This document specifies graphical symbols for diagrams related to industrial components, products and processing.

This document constitutes a symbol library, from which users can use the symbols or created symbol examples for use in diagrams (see Tables 1 to 149).

General rules and guidance for the preparation and presentation of graphical symbols are given in ISO 14617-1. Application rules for the symbols are shown in normative Annex A.

This document does not apply to:

—    graphical symbols for fluid power objects, see ISO 1219-1 (the collective application standard of the ISO 14617 series);

—    symbols of measurement and control functions such as mathematical functions and process functions;

—    graphical symbols for electrotechnical objects, see the IEC 60617 database.

Symbols deleted from the previous edition of the ISO 14617 series are summarized in informative Annex B as a reference. The alphabetic index of symbols defined in this document is shown in informative Annex C.


Paper and board — Determination of colour by diffuse reflectance — Part 1: Indoor daylight conditions (C/2°)

Papier et carton — Détermination de la couleur par réflectance diffuse — Partie 1: Conditions d’éclairage intérieur de jour (C/2°)

This document specifies a method for measuring the colour of paper and board by the diffuse reflectance method with the elimination of specular gloss.

This document is not applicable to coloured papers or boards which incorporate fluorescent dyes or pigments. It may be used to determine the colour of papers or boards which contain fluorescent whitening agents provided the UV content of the illumination on the test piece has been adjusted to conform to that in the CIE illuminant C, using a fluorescent reference standard that fulfils the requirements for international fluorescent reference standards of level 3 (IR3) as prescribed by ISO 2469 with an assigned ISO brightness value provided by an authorized laboratory, as described in ISO 2470‑1.


Agricultural and forestry machinery — Inspection of sprayers in use — Part 1: General

Matériel agricole et forestier — Contrôle des pulvérisateurs en service — Partie 1: Généralités

This document defines the general requirements to be fulfilled for the inspection of all types of sprayers for plant protection products used in agriculture, horticulture, forestry and other areas, except knapsack sprayers.

NOTE            For knapsack sprayers, see ISO/FDIS 19932–3:—.

The specific requirements for the different types of sprayers are defined in the relevant specific parts of the ISO 16122 series. When used in conjunction with the relevant sprayer specific part (see Annex A), this document specifies the requirements and test methods for the inspection of sprayers in use.

The requirements relate mainly to the condition of the sprayer with respect to potential risks for the environment and its performance to achieve a good application.

This document also includes minimum requirements for the preparation of the sprayer for the inspection and the minimum safety requirements with respect to the safety of the inspector (test operator) during the inspection.


Paper and board — Determination of colour by diffuse reflectance — Part 2: Outdoor daylight conditions (D65/10°)

Papier et carton — Détermination de la couleur par réflectance diffuse — Partie 2: Conditions de lumière du jour extérieure (D65/10°)

This document specifies a method for measuring the colour of paper and board by the diffuse reflectance method with the elimination of specular gloss.

It can be used to determine the colour of papers or boards that contain fluorescent whitening agents, provided the UV content of the illumination on the test piece has been previously adjusted to give the calibrated colorimetric value corresponding to CIE standard illuminant D65, using a fluorescent reference standard with an assigned CIE whiteness (D65/10°) value provided by an authorized laboratory, as described in ISO 11475.

This document is not applicable to coloured papers or boards that incorporate fluorescent dyes or pigments.


Agricultural and forestry machinery — Inspection of sprayers in use — Part 2: Horizontal boom sprayers

Matériel agricole et forestier — Contrôle des pulvérisateurs en service — Partie 2: Pulvérisateurs à rampe horizontale

This document, when used together with ISO 16122-1:2024, specifies the requirements and test methods for the inspection of horizontal boom sprayers, when in use.

The requirements relate to the condition of the sprayer with respect to its potential risk for the environment and its performance to achieve good application.

NOTE            Requirements for the protection of inspectors during an inspection are given in ISO 16122-1:2024.


Paper and board — Determination of colour by diffuse reflectance — Part 3: Indoor illumination conditions (D50/2°)

Papier et carton — Détermination de la couleur par réflectance diffuse — Partie 3: Conditions d'éclairage intérieur (D50/2°)

This document specifies a method for measuring the colour of paper and board by the diffuse reflectance method with the elimination of specular gloss.

This document is primarily intended for measuring the colour of paper and board to be used in the graphic arts industry, where that industry specifies the measurement of colour under D50/2° conditions in accordance with ISO 13655. This method differs from ISO 13655, in that the UV content of the illumination is adjusted to a different level.

The method can be used to determine the colour of papers or boards that contain fluorescent whitening agents, provided the UV content of the illumination on the test piece has been adjusted to conform to that in the CIE illuminant C, using a fluorescent reference standard that fulfils the requirements for international fluorescent reference standards of level 3 (IR3) as prescribed by ISO 2469 with an assigned ISO brightness value provided by an authorized laboratory, as described in ISO 2470‑1.

This document is not applicable to coloured papers or boards that incorporate fluorescent dyes or pigments.


Agricultural and forestry machinery — Inspection of sprayers in use — Part 3: Sprayers for bush and tree crops

Matériel agricole et forestier — Contrôle des pulvérisateurs en service — Partie 3: Pulvérisateurs pour cultures arbustives et arboricoles

This document, when used together with ISO 16122-1:2024, specifies the requirements and test methods for the inspection of sprayers for bush and tree crops, when in use.

The requirements relate mainly to the condition of the sprayer with respect to its potential risk for the environment and its performance to achieve good application.

NOTE            Requirements for the protection of inspectors during an inspection are given in ISO 16122-1:2024.


Agricultural and forestry machinery — Inspection of sprayers in use — Part 4: Fixed and semi-mobile sprayers

Matériel agricole et forestier — Contrôle des pulvérisateurs en service — Partie 4: Pulvérisateurs fixes et semi-mobiles

This document, when used together with ISO 16122-1:2024, specifies the requirements and test methods for the inspection of fixed and semi-mobile sprayers, when in use.

The requirements relate mainly to the condition of the sprayer with respect to its potential risk for the environment and its performance to achieve good application.

NOTE            Requirements for the protection of inspectors during an inspection are given in ISO 16122-1:2024.


Agricultural and forestry machinery — Environmental requirements for sprayers — Part 1: General

Matériel agricole et forestier — Exigences environnementales pour les pulvérisateurs — Partie 1: Généralités

This part of ISO 16119 specifies general requirements for the design and performance of sprayers, as defined in ISO 5681, with regard to minimizing the potential risk of environmental contamination during use, including misuse foreseeable by the manufacturer. It also specifies the requirements for identification of the sprayer and certain of its components, and the minimum content of the instruction handbook.
It is intended to be used with each of the other parts of ISO 16119, which give requirements specific to particular types of sprayers (see Annex A). This part of ISO 16119 is applicable to all types of sprayers used in agriculture, horticulture, forestry and other areas, except knapsack sprayers. It does not cover safety aspects (see ISO 4254 6).
•	Scope out liquid fertilizer application
•	Adding Part 5 - Aerial sprayers
•	Instruction handbook content
•	Annex A, table with techniques needs to be updated.
•	Additional standards for application equipment listed in Annex A and covered by mandate M435 and M471 of the EC shall be developed.


Agricultural and forestry machinery — Environmental requirements for sprayers — Part 2: Horizontal boom sprayers

Matériel agricole et forestier — Exigences environnementales pour les pulvérisateurs — Partie 2: Pulvérisateurs à rampe horizontale

This part of ISO 16119 specifies requirements and the means for their verification for the design and performance of horizontal boom sprayers, as defined in 3.1, with regard to minimizing the potential risk of environmental contamination during use, including misuse foreseeable by the manufacturer.

It is intended to be used with ISO 16119 1, which gives general requirements common to all the sprayer types covered by ISO 16119. When requirements of this part of ISO 16119 are different from those which are stated in ISO 16119 1, the requirements of this part of ISO 16119 take precedence over the requirements of ISO 16119 1 for machines within the scope of this part of ISO 16119. It does not cover safety aspects (see ISO 4254 6).

•	Define and specify requirements for ‘Modules’
•	Filling -Total tank extra volume
•	Quick coupler for CTS + mandatory provision of inductor hopper or CTS
•	Filters drain valve
•	Digital level indicator + accuracy
•	Boom automatic section control (>24 m) + ISOBUS task controller
•	Boom nozzle spacing equal location
•	Pump requirements as per ISO 12908: 2020
•	Residue concentration only one method for system rinsing
•	Direct injection definition, requirements, test method


Agricultural and forestry machinery — Environmental requirements for sprayers — Part 3: Sprayers for bush and tree crops

Matériel agricole et forestier — Exigences environnementales pour les pulvérisateurs — Partie 3: Pulvérisateurs pour arbustes et arboriculture


Agricultural and forestry machinery — Environmental requirements for sprayers — Part 4: Fixed and semi-mobile sprayers

Matériel agricole et forestier — Exigences environnementales pour les pulvérisateurs — Partie 4: Pulvérisateurs fixes et semi-mobiles

This part of ISO 16119 specifies requirements and the means for their verification for the design and performance of fixed and semi-mobile sprayers, as defined in 3.1 and 3.2, with regard to minimizing the potential risk of environmental contamination during use, including misuse foreseeable by the manufacturer.
This type of spraying system is generally a combination of separate elements (main tank, pump and application unit) that can be assembled in fixed installations (fixed sprayers) or with moving parts (semi-mobile sprayers).
It does not apply to application equipment for space/spatial treatments.
It is intended to be used with ISO 16119 1, which gives general requirements common to all the sprayer types covered by ISO 16119. When requirements of this part of ISO 16119 are different from those stated in ISO 16119 1, the requirements of this part of ISO 16119 take precedence over the requirements of ISO 16119 1 for machines within the scope of this part of ISO 16119. This part of ISO 16119 does not cover safety aspects (see ISO 4254 6).
•	Filling - Total tank extra volume
•	Quick coupler for CTS + mandatory provision of inductor hopper or CTS
•	Filters drain valve
•	Digital level indicator + accuracy
•	Pump requirements as per ISO 12908: 2020
•	Residue concentration only one method for system rinsing


Paper and board — Determination of alkali reserve

Papier et carton — Détermination de la réserve alcaline

This document specifies a method for the determination of the alkali reserve of papers and boards. lt is intended for products that contain alkaline pigments or other alkaline material, added to improve their resistance to acid attack (degradation).

This document is not applicable to laminated, printed or otherwise processed grades that will not disintegrate completely by the procedure described.

The result obtained will include alkaline pigments contained in the coating of a coated paper.

NOTE   Such alkaline coating will protect the core of the paper from acid substances in ambient air, but its effect on acid substances generated in the base paper itself is uncertain.


Pulps — Determination of limiting viscosity number in cupri-ethylenediamine (CED) solution

Pâtes — Détermination de l'indice de viscosité limite à l'aide d'une solution de cupri-éthylènediamine (CED)

ISO 5351:2010 specifies a method which yields a number that is an estimate of the limiting viscosity number of pulp in a dilute cupri-ethylenediamine (CED) solution.

ISO 5351:2010 is primarily applicable to CED-soluble samples of bleached chemical pulps but can also be applied to any kind of pulp that dissolves completely in CED solution.


Crop protection equipment — Test methods for the evaluation of cleaning systems — Part 1: Internal cleaning of complete sprayers

Matériel de protection des cultures — Méthodes d'essai pour l'évaluation des systèmes de nettoyage — Partie 1: Nettoyage interne de la totalité du pulvérisateur

This part of ISO 22368 specify test method for determining the performance of the rinsing systems on sprayers used in crop protection for the internal cleaning of the complete sprayer including the tank (ISO22368-1), and tank only (ISO22368-3). These are applicable to mounted, trailed and self-propelled agricultural sprayers used for crop protection and liquid fertilizer applications. These are not applicable to sprayers with direct injection systems.


Crop protection equipment — Test methods for the evaluation of cleaning systems — Part 2: External cleaning of sprayers

Matériel de protection des cultures — Méthodes d'essai pour l'évaluation des systèmes de nettoyage — Partie 2: Nettoyage externe des pulvérisateurs

ISO 22368-2:2004 specifies two test methods for evaluating the performance of cleaning systems fitted onto sprayers used in crop protection for the removal of deposits on the external surfaces of the sprayer. The purpose of the tests is to provide sprayer designers with information on contamination of the sprayer and permit comparison of different attachments or adjustments in relation to external cleaning (Test A), and to allow the performance of different cleaning devices to be determined (Test B). It is applicable to mounted, trailed and self-propelled agricultural sprayers used for crop protection and liquid fertilizer applications.


Crop protection equipment — Test methods for the evaluation of cleaning systems — Part 3: Internal cleaning of tank

Matériel de protection des cultures — Méthodes d'essai pour l'évaluation des systèmes de nettoyage — Partie 3: Nettoyage interne du réservoir

ISO 22368-3:2004 specifies a test for determining the performance of the rinsing systems fitted onto sprayers used in crop protection for the internal cleaning of the spray-liquid tank or tanks. It is applicable to mounted, trailed and self-propelled agricultural sprayers used for crop protection and liquid fertilizer applications. It is not applicable to sprayers with direct injection systems.


This document specifies a method of obtaining, for test purposes, a gross sample representative of a certain lot of pulp. This document applies to all kinds of pulp delivered in bales or rolls. It is intended for use when sampling for all kinds of testing purposes except for the determination of saleable mass, in which case other International Standards apply such as ISO 801-1 and ISO 801-2.

If, however, the pulp is to be tested for saleable mass in addition to other properties, the gross sample obtained according to the appropriate International Standard for sampling saleable mass can also be used for the other pulp property tests.


Guidance for use in the application of ISO/IEC Guide 71:2014 — Part 2: Ergonomics design considerations for accessibility

Recommandations d'utilisation dans l'application du Guide ISO/IEC 71:2014 — Partie 2: Considérations en matière de conception ergonomique concernant l'accessibilité

This document provides ergonomics data for standard developers to use in applying ISO/IEC Guide 71:2014 to address accessibility in standards. These data can also be used by ergonomists and designers to support the development of more accessible products, systems, services, environments, and facilities.

The ergonomics data include quantitative data and knowledge about basic human characteristics and capabilities as well as context-specific and task-specific data, all being based on ergonomics research. The data focused on the effects of ageing and/or consequences of various types of human sensory, physical, and cognitive disabilities. It does not contain general ergonomics data that have no direct relation to ageing or disabilities.

The data presented in this document are not exhaustive due to no available data for some aspects of human characteristics and capabilities with regard to ageing and disabilities.


Security and resilience — Community resilience — Framework and principles for energy resilience

This document describes the principles, framework and approach toward energy resilience.

Specifically, this document provide:
‒ a definition of energy resilience consistent with ISO 22300 (for example, Energy Resilience: ability of an energy supply chain to absorb and adapt in a changing environment).
‒	a set of essential organizational qualities of an energy supply chain required to achieve energy resilience for communities, nations and regions.
‒	a framework and concept of “Energy resilience” for any organizations to reduce unexpected adverse impact on an energy supply chain and adapt to changes in the operating environment.This is sometimes referred to as a ‘Build Back Better’ objective, especially after an energy supply disruption incident caused by natural or man-made disasters, or other crises. Energy resilience aims to enable the provision of stable energy supply during and after significant changes in operating environments, including disasters.
‒	framework for involving community, national and regional stakeholders to enhance recognition of energy supply risk context, fostering social capital (trust, participation and collaboration), and embracing a polycentric governance model for enhancing energy resilience.
‒		principles for recognizing and understanding social and technological contexts; and fostering social capital such as trust, broad participation and collaborative stakeholder networks.
‒	principles for improving the robustness, connectivity, redundancy, response diversity and functional diversity of an energy supply chain to enhance energy resilience.
‒	principles for encouraging knowledge sharing, learning and adaptation at all steps in the energy supply chain involving all stakeholders, including organizational change needed to fit new developments in energy supply chain technologies and market demands.
‒	principles for ensuring the structure of collaborative organizations involved in the supply chain have a good ‘fit’ with the structure of the built systems.
‒	principles for managing complexity, for example adopting mental models that acknowledge the complex adaptive systems nature of an infrastructure-dependent system being governed. Understand that linear, reductionist thinking (which is common in supply chains) is often a root cause of erosion of resilience.
‒	preparedness for supply chain surprises, disruptions and disasters
‒	enhancement and improvement of energy resilience

This document is to provide framework and concept of “Energy resilience” to any organizations to reduce adversely impact and achieve the Build Back Better from incident caused by natural and human made disasters.

This document aims to provide a framework and principles of “Energy resilience” that can be utilized by any organizations in the energy supply chain, responders and the responsible authorities, to reduce adverse impacts of high consequence risk events including protection of society and communities.

Energy resilience enables the provision of stable energy supply during and after an incident.

The scope of this document will include broad resilience engineering and management principles applicable to a socio-technical energy supply chain but will not include guidance on the implementation of these principles for specialized engineering purposes. For example, engineering details about power generation systems, power grids and transmission systems, and backup generators are not included.


Connections for hydraulic fluid power and general use — Ports and stud ends with ISO 261 metric threads and O-ring sealing — Part 1: Ports with truncated housing for O-ring seal

Raccordements pour transmissions hydrauliques et applications générales — Orifices et éléments mâles à filetage métrique ISO 261 et joint torique — Partie 1: Orifices à joint torique dans un logement tronconique

This document specifies dimensions for metric ports for use with the adjustable and non-adjustable stud ends as described in ISO 6149‑2 and ISO 6149‑3.

Ports in accordance with this document can be used at working pressures up to 63 MPa (630 bar[1]) for non-adjustable stud ends and 40 MPa (400 bar) for adjustable stud ends. The permissible working pressure depends upon port size, materials, design, working conditions, application, etc. See ISO 6149‑2 and ISO 6149‑3 for pressure ratings.

NOTE      The Introduction of this document gives recommendations for ports and stud ends to be used for new designs in hydraulic fluid power applications.

[1] 1 bar = 0,1 MPa = 105 Pa; 1 MPa = 1 N/mm2.


Evaluation of bactericidal activity of a non-porous antimicrobial surface used in a dry environment

Évaluation de l’activité bactéricide d’une surface antimicrobienne non poreuse utilisée dans un environnement sec

This document specifies the test conditions and the levels of activity to determine the bactericidal activity of non-porous surfaces used in a dry environment. It defines a protocol to validate the bactericidal character of a surface and to measure its performance. It is not intended to be used to substantiate cleaning or disinfecting properties.

This document is applicable to surfaces claiming to have an activity against vegetative bacteria. The obligatory test conditions are defined in this document. It does not apply to porous surfaces.

It does not refer to methods for testing the toxicological and ecotoxicological properties of the surfaces. This document is used to measure bactericidal action, not bacteriostatic activity of a surface.


Railway applications – Functional characteristics of a conformity assessment scheme for railway quality management system

This document provides a collection of essential functional characteristics of a conformity assessment (CA) scheme for railway quality management system (RQMS).


Welding — Recommendations for welding of metallic materials — Part 9: Welding of unalloyed and low alloyed steel castings

Soudage — Recommandations pour le soudage des matériaux métalliques — Partie 9: Soudage à l'arc des aciers moulés non alliés et faiblement alliés

This document specifies the requirements for fusion welding of unalloyed and low alloyed steel castings produced in accordance with e.g.:
—	EN 10213, Steel castings for pressure purposes;
—	EN 10293, Steel castings for general engineering uses;
—	EN 10340, Steel castings for structural uses.


Information technology — Automatic identification and data capture techniques — QR code bar code symbology specification

Technologies de l'information — Technologie d'identification automatique et de capture des données — Spécification de la symbologie de code à barres code QR

This document specifies requirements for the symbology known as “QR code”. It specifies the QR code symbology characteristics, data character encoding methods, symbol formats, dimensional characteristics, error correction rules, reference decoding algorithm, production quality requirements and user-selectable application parameters.


Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols

Techniques automatiques d'identification et de capture des données — Spécifications pour essai de qualité d'impression des codes à barres — Symboles linéaires

This document

—     specifies the methodology for the measurement of specific attributes of bar code symbols,

—     defines a method for evaluating these measurements and deriving an overall assessment of symbol quality, and

—     gives information on possible causes of deviation from optimum grades to assist users in taking appropriate corrective action.

This document applies to those symbologies for which a reference decode algorithm has been defined, and which are intended to be read using linear scanning methods, but its methodology can be applied partially or wholly to other symbologies.


Plastics piping systems for the supply of gaseous fuels — Unplasticized polyamide (PA-U) piping systems with fusion jointing and mechanical jointing — Part 8: Training and assessment of fusion operators

Systèmes de canalisations en matières plastiques pour la distribution de combustibles gazeux — Systèmes de canalisations en polyamide non plastifié (PA-U) avec assemblages par soudage et assemblages mécaniques — Partie 8: Formation et évaluation des opérateurs de soudage

This document specifies the training, assessment and approval of fusion operators, with the aim of establishing and maintaining their competency in the construction of unplasticized polyamide (PA-U) piping systems for the supply of gaseous fuels in accordance with ISO 16486‑6. It covers the butt fusion and electrofusion fusion jointing techniques and considers both the theoretical and practical knowledge necessary for making high-quality fusion joints.


Stationary training equipment — Part 2: Strength training equipment — Additional specific safety requirements and test methods

Appareils d’entraînement fixes — Partie 2: Appareil d’entraînement de force — Exigences spécifiques de sécurité et méthodes d’essai supplémentaires

This document specifies safety requirements for stationary strength training equipment, in addition to the general safety requirements of ISO 20957-1:2013.

This document is applicable to stationary strength training equipment with stacked weight resistance or alternative means of resistance, such as elastic cords, hydraulic, pneumatic, electrical, magnetic, springs and externally loaded weights (hereinafter referred to as stationary training equipment) with the classes H, S and I according to ISO 20957-1:2013.

NOTE            Accuracy classes are not applicable to this type of stationary training equipment as accuracy classes do not affect the safety of this equipment.


Stationary training equipment — Part 7: Rowing equipment — Additional specific safety requirements and test methods

Appareils d’entraînement fixes — Partie 7: Rameurs — Exigences spécifiques de sécurité et méthodes d'essai supplémentaires

This document specifies safety requirements for rowing equipment, in addition to the general safety requirements of ISO 20957-1:2013.

This document is applicable to rowing type stationary training equipment, hereinafter referred to as rowing equipment, within the classes H, S and I and classes A, B and C regarding accuracy.


Environmental solid matrices — Determination of elements using inductively coupled plasma mass spectrometry (ICP-MS)

Matrices solides environnementales — Détermination des éléments par spectrométrie de masse avec plasma induit par haute fréquence (ICP-MS)

This document specifies a method for the determination of the following elements in aqua regia, nitric acid or mixture of hydrochloric (HCl), nitric (HNO3) and tetrafluoroboric (HBF4)/hydrofluoric (HF) acid digests of soil, treated biowaste, waste, sludge and sediment using inductively coupled plasma mass spectrometry (ICP-MS):
Aluminium (Al), antimony (Sb), arsenic (As), barium (Ba), beryllium (Be), bismuth (Bi), boron (B), cadmium (Cd), calcium (Ca), cerium (Ce), cesium (Cs), chromium (Cr), cobalt (Co), copper (Cu), dysprosium (Dy), erbium (Er), europium (Eu), gadolinium (Gd), gallium (Ga), germanium (Ge), gold (Au), hafnium (Hf), holmium (Ho), indium (In), iridium (Ir), iron (Fe), lanthanum (La), lead (Pb), lithium (Li), lutetium (Lu), magnesium (Mg), manganese (Mn), mercury (Hg), molybdenum (Mo), neodymium (Nd), nickel (Ni), palladium (Pd), phosphorus (P), platinum (Pt), potassium (K), praseodymium (Pr), rhenium (Re), rhodium (Rh), rubidium (Rb), ruthenium (Ru), samarium (Sm), scandium (Sc), selenium (Se), silicon (Si), silver (Ag), sodium (Na), strontium (Sr), sulfur (S), tellurium (Te), terbium (Tb), thallium (Tl), thorium (Th), thulium (Tm), tin (Sn), titanium (Ti), tungsten (W), uranium (U), vanadium (V), ytterbium (Yb), yttrium (Y), zinc (Zn), and zirconium (Zr).
The working range depends on the matrix and the interferences encountered.
The method detection limit of the method is between 0,1 mg/kg dry matter and 2,0 mg/kg dry matter for most elements. The limit of detection will be higher in cases where the determination is likely to be interfered or in case of memory effects


Ships and marine technology — Energy efficiency — Part 2: Energy efficiency of maritime functional systems

Navires et technologie maritime — Efficacité énergétique — Partie 2: Efficacité énergétique des systèmes fonctionnels maritimes

This document specifies generic measuring and calculation methods to evaluate the energy efficiency of multiple components connected in a functional system installed on board ships, vessels for inland navigation and offshore structures.

A maritime functional system consists of multiple components integrating multiple functions, working together to achieve an overall goal.

The purpose of this document is to show how the energy efficiency of various functional systems correspond to the other installations on board of same functionality, thus ensuring that efficient design is rewarded.

Maritime systems are grouped according to their functionality, to compare the energy efficiency of functional systems which can fulfil the same task on board a ship.

This document is applicable to only the functional systems for which a unit output can be clearly defined, and which require energy to function.

This document is applicable to energy consuming functional systems. It does not provide a life cycle assessment (LCA).

NOTE            An LCA can prove useful when considering systems which consume substances, and which would not meet the functional requirements without the use of these substances. An example is a ballast water management system (BWMS) using active substances (these types are not considered in this document).

This document is applicable to the following five types of functional systems:

a)       pressure and flow;

b)       lighting;

c)        heating and cooling;

d)       mechanical;

e)       propulsion.


Ships and marine technology — Energy efficiency — Part 1: Energy efficiency of individual maritime components

Navires et technologie maritime — Éfficacité énergétique — Partie 1: Efficacité énergétique des éléments maritimes individuels

This document specifies generic measuring and calculation methods to evaluate the energy efficiency of individual maritime components installed on board ships, vessels for inland navigation or offshore structures. This document only covers energy consuming components for which a “unit output” can be clearly defined and which require energy to function.

This document only covers the major energy consuming components of a typical ship. It does not cover the propulsion component of the ship (e.g. the propeller).


Biotechnology — Cell viability analytical methods — Part 1: General requirements and considerations

This document specifies definitions and general requirements for cell viability analytical methods. It provides general considerations for selecting and establishing fit-for-purpose cell viability analytical methods. It also provides considerations for managing sources of variability for cell viability measurements during pre-analytical, analytical, and post-analytical phases.
This document is applicable to cells in suspension, cells adhered to a substrate, and cells in complex matrices.
This document is primarily applicable to cell viability measurements of nucleated mammalian cells.
Several sector/application-specific international and national standards for cell viability currently exist.  When applicable, the user can consult existing standards when operating with their scope.


This document specifies the suitable procedures and methods for the decommissioning of cyclotrons used by physics experiments and radioisotope production. For this purpose, computer simulation and real measurement of activated materials method can be employed.


Environmental solid matrices — Determination of elemental composition by X-ray fluorescence spectrometry

Matrices solides environnementales — Détermination de la composition élémentaire par spectrométrie de fluorescence X

This document specifies the procedure for a quantitative determination of major and trace element concentrations in homogeneous solid waste, soil, soil-like material and sludge by energy dispersive X-ray fluorescence (EDXRF) spectrometry or wavelength dispersive X-ray fluorescence (WDXRF) spectrometry using a calibration with matrix-matched standards.
This document is applicable for the following elements: Na, Mg, Al, Si, P, S, Cl, K, Ca, Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, As, Se, Br, Rb, Sr, Y, Zr, Nb, Mo, Ag, Cd, Sn, Sb, Te, I, Cs, Ba, Ta, W, Hg, Tl, Pb, Bi, Th and U. Concentration levels between approximately 0,000 1 % and 100 % can be determined depending on the element and the instrument used.


Railway infrastructure — Rail mounted construction, maintenance and inspection machines — Explanation of machine type

Infrastructure ferroviaire — Machines de construction, de maintenance et d'inspection montées sur rail — Explication du type de machine

This document describes the different modes of operation and the classification of machine types.

This document covers machines fitted with rail wheels that are used for the construction, maintenance, inspection, repair and renewal of railway infrastructure. These include:

—     on-track machines (OTMs), which are specially designed for construction and maintenance of the track and infrastructure;

—     infrastructure inspection vehicles, which are utilised to monitor the condition of the infrastructure;

NOTE            Inspection of the infrastructure includes measurement.

—     environment vehicles, which are designed for clearance of the track from environmental conditions such as snow clearance machines;

—     emergency vehicles, which are designed for a specific emergency use such as evacuation, firefighting and recovery of trains (including breakdown cranes);

—     road-rail machines, which are able to move on railway track and on the ground;

—     trolleys and portable machines that are manually moved along the railway track.


Railway infrastructure — Track quality evaluation — Chord-based method

Applications ferroviaires — Qualité géométrique de la voie — Méthode sur la base du cordeau

This document describes the relationship between an inertial measurement system and a chord measurement system applying the chord-based method with different chord length and chord division.

This document is applicable to 1 435 mm and wider track gauges. This document does not apply to urban/light rail systems, tramways and any track gauge narrower than 1 435 mm.


Machines outils — Sécurité — Presses plieuses

This document specifies technical safety requirements and measures to be adopted by persons undertaking the design, manufacture and supply of press brakes which are intended to work cold metal or material partly of cold metal but which can be used in the same way to work other sheet materials (e.g. cardboard, plastic, rubber, leather, etc.) and also referred to as machines.
NOTE 1 The design of a machine includes the study of the machine itself, taking into account all phases of the “life” of the machine mentioned in ISO 12100:2010, 5.4, and the drafting of the instructions related to all the above phases.
This document covers the following types of machines (see Annex J) :
-	Hydraulic press brakes
-	Hydraulic servo-drive press brakes
-	Screw servo-drive press brakes
-	Belt-spring servo-drive press brakes

The requirements in this document take account of intended use, as defined in ISO 12100:2010, 3.23, as well as reasonably foreseeable misuse, as defined in ISO 12100:2010, 3.24. This document presumes access to the press brake from all directions, deals with all significant hazards during the various phases of the life of the machine described in Clause 4, and specifies the safety measures for both the operator and other exposed persons.

NOTE 2 All significant hazards means those identified or associated with press brakes at the time of the publication of this document.
This document applies to press brakes which can function independently or in combination (e.g. two machines in tandem or more) and can also be used as a guide for the design of press brakes which are intended to be integrated in a manufacturing system.
This document deals with the significant hazards, hazardous situations and events relevant to press brakes and ancillary devices (see Clause 4). This document specifies the safety requirements for press brakes defined in this clause.
This document does not cover press brakes which transmit energy to impart beam motion by using pneumatic means or mechanical clutch or press brakes that use combination of technologies (e.g. combined hydraulic and screw servo-drive press brake or combined hydraulic servo-drive and screw servo-drive press brake)
This document does not cover machines whose principal designed purpose is:
a)	sheet folding by rotary action;
b)	tube and pipe bending by rotary action;
c)	roll bending.
This document does not cover hazards related to the use of press brakes in explosive atmospheres.
This document is not applicable to press brakes which are manufactured before the date of its publication.
This document does not cover the safety aspect of equipment for automatic loading and unloading where provided. Guidance on how to take into account additional automatic loading and unloading equipment can be found in ISO 11161.


Road vehicles — Test devices for target vehicles, vulnerable road users and other objects, for assessment of active safety functions — Part 5: Requirements for powered two-wheeler targets

Véhicules routiers — Dispositifs d'essai pour véhicules cibles, usagers de la route vulnérables et autres objets, pour l'évaluation de fonctions de sécurité active — Partie 5: Exigences pour cibles de deux-roues motorisées

This document specifies performance requirements for surrogate targets used to assess the system detection and activation performance of active safety systems.

This document specifies the properties of an omni-directional multi-purpose powered two-wheeler (PTW) target for assessment of interaction in a variety of traffic scenarios.

This document specifies the properties of a PTW target (PTWT) representing a powered two-wheeler in terms of size, shape, reflection properties, etc. for testing purposes. This document addresses the detection requirements for a PTWT in terms of sensing technologies commonly in use at the time of publication of this document, and where possible, anticipated future sensing technologies. It also addresses methodologies to verify the target response properties to these sensors, as well as performance requirements for the target carrier.

The PTWTs specified in this document reflect two-wheeled vehicles corresponding to UN Category L31) and to UN Category L12), with the restrictions that the vehicle is not intended for human propulsion (for example, pedalling) and its two wheels are inline.

This document also addresses requirements for motion and positioning during test for PTWT including target carrier system.

This document does not address the test procedures in terms of speeds, positions or timing of events. Performance criteria for the active safety system are also not addressed.

1)  The vehicle categories are defined in Consolidated Resolution on the Construction of Vehicles (R.E.3): https://www.unece.org/trans/main/wp29/wp29wgs/wp29gen/wp29resolutions.html .

2)  See https://www.unece.org/trans/main/wp29/wp29wgs/wp29gen/wp29resolutions.html .


Software and systems engineering — Methods and tools for temporal management in feature-based software and systems product line engineering

This International Standard provides configuration management guidance for feature-based PLE as defined in ISO/IEC 26580.  Because a PLE factory in ISO/IEC 26580 aggregates shared assets across multiple lifecycle domains and tools, such as requirements, models, source code, documentation, test cases, calibration data, and so forth, the CM capabilities of the different lifecycle domains have to be aligned and integrated into a holistic CM solution.  We refer to this integrated PLE factory CM solution as Temporal Management.  Using the system-of-systems concept, Temporal Management is the overarching system that arises from the aggregation of the individual CM systems for the tools for the constituent lifecycle domains in a feature-based PLE solution.

As the name implies, the scope of temporal management deals with product line variation in time, but specifically excludes variation across product space since that is fully prescribed in ISO/IEC 26580.  Other feature-based PLE concerns identified in ISO/IEC 26580 that are outside of the scope of Temporal Management in this document include the following, which will be topics of future standards in the 2658X series.

•	Change control and change management;
•	Traceability, relationships, and digital threads among the artefacts in the different lifecycle domains.

Configuration management of the individual elements in a PLE Factory, including each of the shared assets across the lifecycle domains, feature catalogue, and bills-of-features, can be handled by configuration management tools and methods for each of those individual elements.

Because ISO/IEC 26580 is a specialization of the more general description of PLE in ISO/IEC 26550, the scope of this International Standard is likewise a more narrowly focused specialization of the ISO/IEC 26563 CM standard associated with ISO/IEC 26550.

The intended audience for this document comprises:
•	technology providers who wish to provide temporal management for their ISO/IEC 26580 compliant feature-based PLE factory;
•	champions within an organization who wish to introduce feature-based PLE throughout that organization;
•	IT staff within a PLE organization who will introduce and maintain the necessary technology to support temporal management in feature-based PLE;
•	practitioner stakeholders who will use the temporal management tools and methods to practice feature-based PLE;
•	technical and business managers who will sponsor and direct the methods necessary to practice temporal management in feature-based PLE;
•	university professors, researchers, corporate trainers, and other educators who will create and share pedagogical materials and benefits regarding temporal management in feature-based PLE.


Information technology — Process assessment — Process assessment model for safety processes

This document defines a process assessment model for safety processes, conformant with the requirements of ISO/IEC33004, for use in performing a conformant assessment in accordance with the requirements of ISO/IEC33002.
This document supports the use of the process assessment models for system and software life cycle processes (ISO/IEC 33060 and ISO/IEC 33061) when applied to assessment of processes in the development of (functional or non-functional) safety related systems in order to make consistent judgment regarding process quality and/or improvement priorities.


Software and systems engineering — Agile and DevOps principles and practices — Part 1: Agile principles and practices


Software and systems engineering — Agile and DevOps principles and practices — Part 2: DevOps principles and practices


Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le domaine de la santé — Partie 1: Évaluation et essais au sein d'un processus de gestion du risque

This document specifies:

—     the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments;

—     the general categorization of gas pathways based on the nature and duration of their contact with the gas stream;

—     the evaluation of existing relevant data from all sources;

—     the identification of gaps in the available data set on the basis of a risk analysis;

—     the identification of additional data sets necessary to analyse the biological safety of the gas pathway;

—     the assessment of the biological safety of the gas pathway.

This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal condition. This document does not cover biological hazards arising from mechanical damage.

The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.

This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.

This document applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use).

This document does not address biological evaluation of the surfaces of medical devices that have direct contact with the patient or user. The requirements for direct contact surfaces are found in the ISO 10993 series.

Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.

This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.

EXAMPLE            Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).