Industrial automation systems and integration — Product data representation and exchange — Part 4439: Application domain model: Product life cycle support

Systèmes d'automatisation industrielle et intégration — Représentation et échange de données de produits — Partie 4439: Modèle de domaine d'application : Soutien du cycle de vie du produit

This document specifies the application domain model for product life cycle support.

The following are within the scope of this document:

information for defining a complex product and its support solution;

information required to maintain a complex product;

information required for through life configuration change management of a product and its support solution;

the representation of product assemblies including:

the identification and representation of parts, their versions, definitions, and documentation and management information, such as dates and approvals assigned to parts;

the representation of multiple product structure views and product breakdowns;

the representation of the shape of an assembly as the composition of the shape representation of its components;

the identification of positions within an assembly of parts to which component parts can be attached;

the association of valued properties to a part or to an assembly;

the representation of interfaces between products;

the classification of parts, documents and assemblies.

the representation of a product through life including:

the representation of product requirements and their fulfilment;

the representation of existing or potential future products;

the identification of the configuration of a product for a given role;

the specification of effectivity constraints applied to configuration of a product;

the representation of predicted and observed states of products.

the specification and planning of activities for a product including:

the specification of tasks to be performed on a product;

the representation of conditions for performing the tasks, including the resources required and the location of the resources and product;

the representation of the type of person and skills required for performing a task;

the representation of planning and scheduling of the tasks and the management and authorization of the subsequent work.

the representation of the activity history of a product including:

the recording of the usage of a product and the resource usage;

the recording of the activities performed on a product and the resource usage.

the representation of the product history including:

a historical record of the states of a product;

a historical record of the configuration status of the product;

the location of product data;

the observation of product data.

The following are outside the scope of this document:

the representation of business transactions for ordering, supplying or returning products and other resources needed for product support;

the representation of business transactions concerning the transportation, shipment and receipt of products and other resources needed for product support.


Industrial automation systems and integration — Product data representation and exchange — Part 4442: Domain model: Managed model based 3D engineering domain

Systèmes d'automatisation industrielle et intégration — Représentation et échange de données de produits — Partie 4442: Modèle du domaine: Modèle du domaine fondé sur l'ingénierie 3D Domain model

ISO/TS 10303-4442 specifies the business object model for managed_model_based_3d_engineering_domain.

The following are within the scope of ISO/TS 10303-4442:

domain objects in ISO 10303-242, managed model-based 3D engineering;

business terminology used to describe capabilities in a manner that will facilitate the development of application programmer interfaces for ISO 10303-242, managed model-based 3D engineering;

business terminology suited for the communication with and understandability by domains experts of Aerospace and Defence and Automotive;

domain object XML Schema for ISO 10303-242;

mappings to the application protocol ARM.


Paints and varnishes — Coating systems for wind-turbine rotor blades — Part 1: Minimum requirements and weathering

Peintures et vernis — Matériaux de revêtement pour pales de turbines éoliennes — Partie 1: Exigences minimales et érosion

This document specifies minimum requirements and weathering for coating systems for wind-turbine rotor blades.


Paints and varnishes — Coating systems for wind-turbine rotor blades — Part 2: Determination and evaluation of resistance to rain erosion using rotating arm

Peintures et vernis — Matériaux de revêtement pour pales de turbines éoliennes — Partie 2: Détermination et évaluation de la résistance à l'érosion causée par la pluie au moyen d'un bras rotatif

This document specifies a test method for the determination of resistance of coating systems or tape for wind-turbine rotor blades to rain erosion by using the rotating arm test.


Evaluation of the virucidal activity of a surface following hand contamination

Évaluation de l'activité virucide d'une surface suite à une contamination des mains

This document specifies the test conditions and the levels of activity to determine the antiviral activity of a non-porous surfaces used in a dry environment and contaminated by a hand transfer. It defines a protocol to determine the logarithmic reduction in the number of TCID50/cm2 between a reference surface and an antimicrobial surface for a given contact time. The protocols simulates the hand contamination by using a finger with soil loads to transfer a dry inoculum onto the surface.
It is not intended to be used to substantiate cleaning or disinfecting properties.
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


Paints and varnishes — Determination of wet-scrub resistance of coatings

The ability of coatings to withstand wear caused by repeated cleaning operations and to withstand penetration by soiling agents is an important consideration both from a practical point of view and when comparing and rating such coatings. ISO 11998:2006 describes an accelerated method for the determination of wet-scrub resistance. With regard to the cleanability of coatings, only the method itself and not the soiling agents are specified.


Fertilizers, Soil conditioners and Beneficial Substances — Simultaneous Determination of free amino acid content

This document specifies the methods for determining the content of free amino acids in fertilizers, including the use of automatic amino acid analyzers, pre-column derivatization followed by high-performance liquid chromatography and high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS). These methods are applicable to the following amino acids: Asparagine Tryptophan, Glutamine, Theanine, Aspartic acid, Threonine, Serine, Glutamic acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Histidine, Lysine, Arginine, and Cysteine.


Systems and software engineering — Systems and software assurance — Part 1: Concepts and vocabulary

Ingénierie des systèmes et du logiciel — Assurance des systèmes et du logiciel — Partie 1: Concepts et vocabulaire

This document defines assurance-related terms and establishes an organized set of concepts and relationships to form a basis for shared understanding across user communities for assurance. It provides information to users of the other parts of ISO/IEC/IEEE 15026 including the combined use of multiple parts. The essential concept introduced by ISO/IEC/IEEE 15026 (all parts) is the statement of claims in an assurance case and the support of those claims through argumentation and evidence. These claims are in the context of assurance for properties of systems and software within life cycle processes for the system or software product.

Assurance for a service being operated and managed on an ongoing basis is not covered in ISO/IEC/IEEE 15026 (all parts).

A variety of potential users of ISO/IEC/IEEE 15026 (all parts) exists including developers and maintainers of assurance cases and those who wish to develop, sustain, evaluate or acquire a system that possesses requirements for specific properties in such a way as to be more certain of those properties and their requirements. ISO/IEC/IEEE 15026 (all parts) uses concepts and terms consistent with ISO/IEC/IEEE 12207 and ISO/IEC/IEEE 15288 and generally consistent with the ISO/IEC 25000 series, but the potential users of ISO/IEC/IEEE 15026 (all parts) need to understand the differences from concepts and terms to which they may be accustomed. This document attempts to clarify these differences.

The primary purpose of this document is to aid users of the other parts of ISO/IEC/IEEE 15026 by providing context, concepts and explanations for assurance, assurance cases and integrity levels. While essential to assurance practice, details regarding exactly how to measure, demonstrate or analyse particular properties are not covered. These are the subjects of more specialized standards of which a number are referenced and included in the Bibliography.


Thermoplastics piping systems for non-pressure underground drainage and sewerage — Test method for the determination of the stress crack resistance of structured-wall polyethylene (PE) pipe materials with recyclates using Un-notched Constant Ligament Stress (UCLS) test

Systèmes de canalisations en matières thermoplastiques pour les branchements et les collecteurs d’assainissement enterrés sans pression - Méthode d'essai pour la détermination de la résistance à la fissuration sous contrainte des matériaux de tubes en polyéthylène (PE) à paroi structurée avec des recyclats en utilisant l'essai de contrainte ligamentaire constante non entaillée (UCLS)

This test method determines the slow crack growth (SCG) behaviour (also known as the stress crack resistance) of polyethylene (PE) materials, incorporating recyclates, used in structured-wall Type B corrugated pipes (ISO 21138-3) for non-pressure gravity flow drainage applications. The test method is appropriate to post-consumer recyclates (PCR) of PE materials, post-industrial recyclates (PIR) of PE materials, and blends of such materials with virgin and/or reworked PE , respectively. The test method can also be used for Types A1 and A2 pipe (ISO 21138-2) materials.

The test method is conducted on un-notched specimens in deionized water and evaluates the time until brittle failure, which is governed by both the crack initiation and crack propagation phases of the SCG mechanism.

The test method utilizes standard testing equipment utilized for other stress crack tests in the drainage pipe industry. Specifically, the test method utilizes a lever-arm loading mechanism, typically with a 5:1 mechanical advantage, to apply a constant load to a dog-bone shaped test specimen immersed in an elevated temperature water bath.


Space systems — Requirements for small spacecraft

Systèmes spatiaux — Exigences relatives aux petits engins spatiaux

This document describes minimum requirements for small spacecraft.

Small spacecraft may employ untraditional spacecraft development and management philosophy. These spacecraft projects are usually budget-limited or mass-limited, which makes a single (exclusive) launch unaffordable.

The scope of this document encompasses different categories of small spacecraft — so-called mini-, micro-, nano-, pico- and femto-, as well as CubeSat, spacecraft. Therefore, for the sake of convenience, the term "small spacecraft" is used throughout this document as a generic term.

Regardless of the development philosophy, there are minimum requirements every spacecraft complies with. This document explicitly states those requirements and also refers to existing applicable standards. In that sense, this document serves as the top document to cover the minimum requirements for various stages of small spacecraft system life-cycle — with emphasis on design, launch, deployment, operation, and disposal phases. In this way, (1) safety, (2) harmlessness to co-passengers and launcher, and (3) debris mitigation, are all assured.

This document is addressed to small spacecraft developers, as well as dispenser providers and/or the launch operators.


Space systems — Cube satellites (CubeSats)

Systèmes spatiaux — Satellites cubiques (CubeSats)

ISO 17770:2017 addresses CubeSats, CubeSat Deployer and related verification of assurance/quality terms and metrics.

ISO 17770:2017 defines a unique class of picosatellite, the CubeSat. CubeSats are ideal as space development projects for universities around the world. In addition to their significant role in educating space scientists and engineers, CubeSats provide a low-cost platform for testing and space qualification of the next generation of small payloads in space. A key component of the project is the development of a standard CubeSat Deployer.

This Deployer is capable of releasing a number of CubeSats as secondary payloads on a wide range of launchers. The standard Deployer requires all CubeSats to conform to common physical requirements, and share a standard Deployer interface. CubeSat development time and cost can be significantly reduced by the development of standards that are shared by a large number of spacecraft.

Normative control of the CubeSat design, qualification and acceptance testing is generally applied from other small satellite specific standards with the exception of CubeSat/Deployer launch environment test.


Space systems — Structural design — Determination of loading levels for static qualification testing of launch vehicles

Systèmes spatiaux — Conception des structures — Détermination des niveaux de chargement pour un essai statique de qualification des véhicules lanceurs

This document specifies a procedure for determining the loading level of a qualification test of a launch vehicle structure and takes into account all the minimum allowable strength characteristics necessary for these structures.


Plastics — Evaluation of the dispersibility and solubility of plastic products under marine conditions

This document specifies test methods and criteria which are to be applied to verify if a solid plastic product is dispersible or soluble in marine environments.

NOTE    Eventual dispersibility and solubility is unrelated to biodegradability. To claim biodegradability only biodegradation standard tests are suitable such as the ISO 23977-series, ISO 18830, ISO 19679 and ISO 22404. These characteristics are useful for knowing whether a plastic product will quickly disappear visually and physically when introduced into seawater. As such it is complementary to ISO 23832 which is measuring the disintegration. Visual or physical disappearance is no proof of biodegradation.


Space systems — Dynamic and static analysis — Exchange of mathematical models

Systèmes spatiaux — Analyse dynamique et statique — Échange de modèles mathématiques

ISO 14954:2005 normalizes the exchange of mathematical models between spacecraft contractors (SCC) and launch service providers (LSP). It identifies standard methods for modelling the dynamic behaviour of both launch vehicles (LV) and spacecraft (SC) particularly when they are coupled prior to launch and during the early moments of the launch phase.

In standard mode, the delivered models represent dynamic and static behaviour at the launcher interface. The requirements provided in ISO 14954:2005 are the minimum necessary for dynamic coupled analysis. They may be not sufficient for stress analysis.

ISO 14954:2005 does not include the validation of spacecraft models.


Space systems — Launch-vehicle-to-spacecraft interfaces

Systèmes spatiaux — Interfaces entre le lanceur spatial et le véhicule spatial

ISO 14303 specifies the interfaces between a launch vehicle (LV) and the spacecraft (SC) being launched, to provide LV and SC organizations with the necessary format for presenting the required technical data on existing and future interfaces. Its intended purpose is to minimize costs and reduce the risks from errors resulting from miscommunication. It does not limit the ability of LV or SC organizations to specify unique requirements.


Space systems — Launch pad and integration site — Facility, system and equipment failure analysis

Systèmes spatiaux — Aire de lancement et site d'intégration — Analyse de défaillance des installations, du système et de l'équipement

ISO 16159:2012 establishes procedures for the analysis of failures that occur during the acceptance testing or operation of launch pad and integration site facilities, systems and equipment. The procedures define the processes for investigating, analysing and identifying the probable causes of failures, and for developing corrective actions to preclude future failures.

The purpose of ISO 16159:2012 is to provide

rules for investigating, analysing and identifying the causes of failures,

sufficient information so that corrective action may be implemented to prevent failure recurrence, and

a uniform method for maintaining records of the findings of all failure causes so as to provide information for other failure investigations.


Plastics — Determination of the degree of biodegradation and disintegration of plastic products under wet anaerobic digestion conditions

This document specifies a method of determining the degree of biodegradation and disintegration of plastic products when exposed to wet mesophilic or thermophilic anaerobic-digestion conditions. This method is based on ISO 13975, amended with a modified approach to determine disintegration.

This method is designed to simulate typical anaerobic digestion conditions for wastewater sludge, the organic fraction of mixed municipal solid waste, manure, or agricultural waste. The test product is exposed in a laboratory test to an inoculum derived from anaerobic digesters operating on wastewater sludge, pre-treated household waste, manure, agricultural waste, or a mixture thereof. The anaerobic decomposition takes place under low-solids (less than 15 % solids) and static non-mixed conditions.

NOTE 1 While many wet anaerobic digestion systems have a pretreatment system designed to retain large, solid products from entering the digestion phase, it cannot always be guaranteed this removal is 100 %. It can therefore be useful to know to what extent a plastic product is biodegrading and disintegrable under these conditions.

NOTE 2 This test method is written for “plastics” but can also be used for other product groups (e.g. packaging).


Space systems — Safety requirements — Part 1: System safety

Systèmes spatiaux — Exigences de sécurité — Partie 1: Sécurité système

This document defines the safety programme and the technical safety requirements that are implemented in order to comply with the safety policy as defined in ISO 14300‑2. It is intended to protect flight and ground personnel, the launch vehicle, associated payloads, ground support equipment, the general public, public and private property, and the environment from hazards associated with space systems. Launch site operations are described by ISO 14620‑2 and flight safety systems in ISO 14620‑3.

The safety policy is applied by implementing a system safety programme, supported by risk assessment, which can be summarized as follows.

a) Hazardous characteristics (system and environmental hazards) and functions with potentially hazardous failure effects are identified and progressively evaluated by iteratively performing systematic safety analyses.

b) The potential hazardous consequences associated with the system characteristics and functional failures are subjected to a hazard reduction sequence whereby:

hazards are eliminated from the system design and operations;

hazards are minimized; and

hazard controls are applied and verified.

c) The risks that remain after the application of a hazard elimination and reduction process are progressively assessed and subjected to risk assessment, in order to:

show compliance with safety targets;

support design trades;

identify and rank risk contributors;

support apportionment of project resources for risk reduction;

assess risk reduction progress; and

support the safety and project decision-making process (e.g. waiver approval, residual risk acceptance).

d) The adequacy of the hazard and risk control measures applied are formally verified in order to support safety validation and risk acceptance.

e) Safety compliance is assessed by the project and safety approval obtained from the relevant authorities.


Space systems — Programme management — Risk management

Systèmes spatiaux — Management de programme — Management des risques

This document defines, extending the requirements of ISO 14300-1, the principles and requirements for integrated risk management on a space project. It explains what is needed to implement a project-integrated risk management policy by any project actor, at any level (i.e. customer, first-level supplier or lower-level suppliers).

This document contains a summary of the general risk management process, which is subdivided into four basic steps and nine tasks. This document is applicable to all the space project phases, as defined in ISO 14300-1.


Space systems — Calibration requirements for satellite-based passive microwave sensors

Systèmes spatiaux — Exigences d'étalonnage des capteurs passifs d'hyperfréquences satellitaires

This document defines the requirements and verification methods from design to on-orbit operation for Satellite Based Passive Microwave Sensors.

This document covers the requirements for, design, analysis, manufacturing, ground tests and on-orbit self-sensor calibration and validation. In addition, this document includes the conditions considered for on-orbit inter-comparison among sensors as preparation for cross-calibration. This document includes some examples on how to apply the development of passive microwave sensors as shown in Annex A through D.


Iron ores — Determination of total iron content using the EDTA photometric titration method — Part 2: Fusion decomposition method

This International Standard specifies an EDTA photometric titration method using fusion decomposition for the determination of the total iron content of iron ores. This method is applicable to a concentration range of 37,00 % to 72,00 % (m/m) of total iron in natural iron ores, iron ore concentrates, and agglomerates, including sinter products.


Plastics — Determination of the degree of biodegradation and disintegration of plastic products under high-solids anaerobic-digestion conditions

This document specifies a method of determining the degree of ultimate anaerobic biodegradability and disintegration of plastic products when exposed to high-solids mesophilic or thermophilic anaerobic-digestion conditions. This method is based on ISO 15985, amended with a modified approach to determine disintegration.

This method is designed to simulate typical anaerobic digestion conditions for the organic fraction of mixed municipal solid waste. The test product is exposed in a laboratory test to an inoculum derived from anaerobic digesters operating only on pre-treated household waste. The anaerobic decomposition takes place under high-solids (more than 20 % solids) and static non-mixed conditions. In case no complete disintegration occurs at the end of the anaerobic phase, the digestate may be transferred to aerobic controlled composting conditions to determine the degree of disintegration after a post-composting phase.

NOTE The test method is written for “plastics”, but can also be used for other product groups (e.g. packaging).


Plastics — Specification for the identification of materials that are suitable for recovery through anaerobic digestion

Plastiques — Spécification relative à l'identification des matières susceptibles d'être valorisées pardigestion anaérobie

This document specifies procedures and requirements for the identification of materials that are
suitable for recovery through anaerobic digestion.
Due to the diversity of anaerobic digestion installations (wet versus dry, mesophilic versus
thermophilic, without post-composting phase versus with post-composting phase) different classes
of digestible materials are elaborated. A distinction can be made between AD-convertible (=
converted to biogas during the anaerobic phase) and AD-compatible (= no or insufficient conversion
to biogas, but no negative influence on the digestate quality and/or compost quality).


Plastics — Determination of the aerobic biodegradation of plastic materials in an aqueous medium — Method by analysis of evolved carbon dioxide in a closed system

Plastiques — Détermination de la biodégradation aérobie des matières plastiques en milieu aqueux — Méthode par analyse du dioxyde de carbone dégagé dans un système fermé

This document specifies a laboratory test method for determining in a closed system the degree and rate of the aerobic biodegradation level of plastic materials, including those containing formulation additives. Biodegradation is determined by measuring the CO2 evolved from plastic materials when exposed in an aqueous medium to an inoculum from activated sludge under laboratory conditions.

If an unadapted activated sludge is used as the inoculum, the test simulates the biodegradation processes which occur in a natural aqueous environment; if a mixed or pre-exposed inoculum is used, the method can be used to investigate the potential biodegradability of a test material.

The conditions described in this document might not always correspond to the optimum conditions for the maximum degree of biodegradation, however this test method is designed to give an indication of the potential biodegradability of plastic materials.

NOTE    This document addresses plastic materials but can also be used for other materials (e.g. natural and/or synthetical polymers, copolymers or mixtures thereof; plastic materials which contain additives such as plasticizers, colorants or other compounds; water-soluble polymers).


Lung ventilators and related equipment — Vocabulary and semantics — Part 1: Lung ventilators

Ventilateurs pulmonaires et équipement associé — Vocabulaire et sémantique — Partie 1: Titre manque

This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable

—     in lung ventilator and breathing-therapy device standards,

—     in health informatics standards,

—     for labelling on medical electrical equipment and medical electrical systems,

—     in medical electrical equipment and medical electrical system instructions for use and accompanying documents,

—     for medical electrical equipment and medical electrical systems interoperability, and

—     in electronic health records.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and ventilator breathing system.

NOTE    This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.

This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.


Vitreous and porcelain enamels — Determination of resistance to chemical corrosion — Part 4: Determination of resistance to chemical corrosion by alkaline liquids using a cylindrical vessel

Émaux vitrifiés — Détermination de la résistance à la corrosion chimique — Partie 4: Détermination de la résistance à la corrosion chimique par des liquides alcalins dans un récipient cylindrique

ISO 28706-4:2016 describes a test method for the determination of the resistance of vitreous and porcelain enamelled articles to attack by alkaline liquids at temperatures between 25 °C and 95 °C. The apparatus used is a cylindrical vessel in which only one enamelled specimen is tested.

NOTE 1       The test method was initially set up for determination of the resistance of vitreous and porcelain enamels to a hot sodium hydroxide solution. Within the scope of this part of ISO 28706, the resistance of other alkaline liquids can be tested.

NOTE 2       This part of ISO 28706, which uses a cylindrical vessel, is generally used for tests carried out on vitreous and porcelain enamel coatings for the chemical industry.


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.


Butadiene rubber (BR), raw — Quantitative test methods for cold flow

Caoutchouc butadiène (BR) brut — Méthodes d'analyse quantitative du flux froid

This document specifies two methods for the determination of cold flow characteristics of raw polybutadiene rubber (BR):
— Method A is a stress relaxation method using the rotorless rheometer;
— Method B is a creep testing method using compression assembly.


Rubber and plastics hose assemblies and tubing assemblies — Determination of gas-leakage by assembly fault

Assemblages de tuyaux et de tubes en caoutchouc et en plastique — Détermination des fuites de gaz par défaut d'assemblage

This document specifies the method for the determination of the volume of gas-leakage from the interface between hose and fitting or interface between tubing and fitting by assembly fault.
Explanation of leakage determined by the test method in this document is provided in Annex A. Conception of leakage is shown in Figure A.1 and A.2.


Space systems — Requirements for space science payloads re-flight

This document specifies technical procedures and work items for space science payloads that support the unknown and uncertain space scientific exploration to perform a re-flight mission, designed to stimulate the output of space scientific research, reduce potential risks, and ensure safety and reliability.

This document establishes a set of requirements for re-flight space science payloads in three phases: (1) re-flight design and validation phase (Phase A), (2) engineering implementation and verification phase (Phase B), and (3) re-flight evaluation and release phase (Phase C). Oriented by the philosophy of inherently unknown and uncertainty in space scientific research, the procedures and items defined in this document will be performed through a three-phase iterative strategy of “Phases A/B/C” to balance scientific goals, configuration status, environmental profile, and the re-flight mission.

This document is applicable to the re-flight space science payload’s ground segment. Spacecraft that integrate re-flight space science payloads could be a retrievable satellite, space lab, space station, or space probe.


Carboxylic-styrene-butadiene rubber latex-- Determination of coagulum content (sieve residue)

Latex de caoutchouc butadiène-styrène carboxylé — Détermination de la teneur en coagulum (refus sur tamis)

This document specifies a method for the determination of the coagulum content (sieve residue) of carboxylic-styrene-butadiene rubber( XSBR) latex.
This document is applicable to XSBR latex intended for use in paper coating.


Digital twin — Extraction and transactions of data components


Guidance on the integration of IoT and digital twins in data spaces


Digital twin — Guidelines for digital entity modeling


Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for small punch creep of porous ceramics-metal composites

This document specifies a small punch creep test method that involves the use of small disc-shaped test specimens for porous ceramics-metal composites. This document can be applied to evaluate the creep characteristics of the materials used for the SOFC fuel electrode and to serve other purposes such as long-term strength reliability evaluations, quality assurance and material development.


Plain bearings — Handling of plain bearings

Paliers lisses — Manipulation des paliers lisses

This document specifies requirements and guidance on the storage, transportation, handling, installation, operation and replacement of plain bearings and related parts.


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

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

ISO 11909:2007 details general test methods for polyisocyanate resins and solutions of polyisocyanate resins intended for use as binders in paints, varnishes and related products.


Blockchain and distributed ledger technologies ― Representing non-financial digital assets using tokens

This document provides an overview, stakeholders, framework, token lifecycles, data category for non-financial digital assets on distributed ledger technologies.
This document is applicable to all organizations.


Paints and varnishes — Coating systems for wind-turbine rotor blades — Part 6: Determination and evaluation of ice adhesion using centrifuge

Peintures et vernis — Matériaux de revêtement pour pales de turbines éoliennes — Partie 6: Détermination et évaluation de l'adhésion de la glace à l'aide d'une centrifugeuse

This document describes a method to measure ice adhesion from artificial ice on test substrates by using a centrifuge. Basic ice types are defined and test parameters for the ice removal are described to achieve reproducibility of test results for ice adhesion measurements for rotor blade coatings. This document does not intend to provide fixed test parameter to account for the diversity of relevant icing scenarios in this field of application.


Glass in building — Vacuum insulating glass — Part 1: Basic specification of products and evaluation methods for performance

This document specifies product specification for vacuum insulating glass. It also specifies evaluation methods for thermal and sound insulating performance and evaluation methods for thermal insulation durability.


Glass in building — Determination of thermal transmittance (U value) — Calculation method

Applies to glass, coated glass and materials opaque in the far infrared wavelengths. Gives the fundamental rules for calculating the thermal transmittance in the glazing central area (edge effects are not included). The rules are intended to enable the heat loss through glazing in a building to be estimated from the U values and, together with heat losses through the opaque elements of the building, are used to determine the capacity of the heating or cooling plant. In addition, U values for other purposes (e.g. condensation on glazing surfaces, seasonal heat loss through glazing) can be calculated using the same procedure.


Vacuum technology — Standard methods for measuring vacuum-pump performance — Part 4: Turbomolecular vacuum pumps

Technique du vide — Méthodes normalisées pour mesurer les performances des pompes à vide — Partie 4: Pompes à vide turbomoléculaires

This document, in conjunction with ISO 21360-1, specifies methods for the measurement of performance characteristics of turbomolecular vacuum pumps. It is applicable to all sizes and all types of turbomolecular vacuum pumps, including those

— with mechanical or magnetic bearings;

— with or without an additional drag stage(s) or other pumping stages on the shaft;

— with one or more inlet ports.

Since turbomolecular vacuum pumps are backed by primary pumps, their performance cannot be completely defined by the volume flow rate curve. Also, the driving device and the backing pressure of the turbomolecular vacuum pump is important to the performance.

The following completes the performance characteristics:

— information about throughputs and backing pressure of the turbomolecular vacuum pump;

— the compression ratio curve (compression ratio vs backing pressure of turbomolecular vacuum pump).


Cranes — Safe use — Part 2: Part 2: Mobile cranes

Appareils de levage à charge suspendue — Sécurité d'emploi — Partie 2: Titre manque

This document establishes required practices for the safe use of mobile cranes, as defined in ISO 4306-2. This document is intended to be used in conjunction with ISO 12480-1.
Subjects covered include safe systems of work, management, planning, selection, erection and  dismantling, operation and maintenance of cranes, the selection of operators, slingers and signalers.
It does not cover manually operated (non-powered) cranes, cranes in which at least one of its motions is  manually operated and cranes mounted on water-borne vessels, except in those circumstances where a land-based crane is temporarily affixed to a vessel.


Determination of Fe Metal in sponge iron and briquettes

This method covers the determination of metallic iron in all the reduced samples by titrimetric method using dichromate.


Small craft — Windows, portlights, hatches, deadlights and doors — Strength and watertightness requirements

Petits navires — Fenêtres, hublots, panneaux, tapes et portes — Exigences de résistance et d'étanchéité

This document specifies technical requirements and test methods for windows, portlights, hatches, deadlights and doors on small craft with a length of hull, LH, as defined in ISO 8666:2016, of up to 24 m. It takes into account the type of craft, its design category, and the location of the appliance.

The appliances considered in this document are only those that are critical for the craft's watertightness.

Openings and non-opening devices fitted below area I (see 3.5.2) are excluded from the scope of this document.


Small craft — Alternating and direct current installations of electrical systems — Part 1: Single-phase AC, Craft low voltage DC

This document specifies the requirements for the design, construction and installation of the following types of DC and AC electrical systems, installed on small craft either individually or in combination:

a) extra-low-voltage direct current (DC) electrical systems that operate at nominal potentials of 50 V DC or less;

b) single-phase alternating current (AC) systems that operate at a nominal voltage not exceeding AC 250 V.

This document does not cover the following:

— electrical propulsion systems of direct current less than 1 500 V DC, single-phase alternating current up to 1 000 V AC, and three-phase alternating current up to 1 000 V AC, which are addressed by ISO 16315;

— any conductor that is part of an outboard engine assembly and that does not extend beyond the outboard engine manufacturers supplied cowling;

— three-phase AC installations that operate at a nominal voltage not exceeding 500 V AC, which are addressed by IEC 60092-507.


Small craft — Alternating and direct current installations of electrical systems — Part 3: Lithium-ion charging

This document describes the requirement of the design, installation and testing of interfaces of onboard AC/DC charging circuits and systems for lithium-ion batteries using shore-power supply, including below.

- Charging and safety system design;
- Charging sequence and communication design;
- Charging monitoring and control design;
- Charging circuit installation;
- Testing of charging system.

This document applies to electric propulsion and electric hybrid (system with a rechargeable battery) small crafts up to 24 m length of the hull (according to ISO 8666) operated in the ranges either individually or in combination of up to 1500V DC nominal and 1000V AC nominal (according to ISO 16315) and does not apply to the following:

- Crafts at dry docking and out of service maintenance and repair;
- Unmanned crafts;
- Pressure crafts;
- Hover craft, wing-in-ground-effect craft, amphibious craft, hydrofoil craft;
- Battery capacity less than 600 Wh (according to ISO 23625).

This document can be used along with the existing relevant standards, such as those referenced in this document, to integrate into a boat.


Water quality — Uranium — Test method using alpha liquid scintillation counting

Qualité de l'eau — Uranium — Méthode d'essai par comptage des scintillations alpha en milieu liquide

This document specifies the measurement method for the determination of total activity concentration of uranium isotopes in non-saline waters by extraction and liquid scintillation counting.

This method covers the measurement of soluble uranium isotopes in water in activity concentrations between approximately 2·10−3 Bq/kg and 10 Bq/kg when analysing a 1 l test sample volume with a 60 000 s counting time with a typical alpha LSC instrument.

The ratio 234U/238U can also be determined. This method has not been tested for the measurement of other uranium isotopes.


Water quality — Plutonium and neptunium — Test method using ICP-MS

Qualité de l'eau — Plutonium et neptunium — Méthode d'essai par ICP-MS

This document specifies methods used to determine the concentration of plutonium and neptunium isotopes in water by inductively coupled plasma mass spectrometry (ICP-MS) (239Pu, 240Pu, 241Pu and 237Np). The concentrations obtained can be converted into activity concentrations of the different isotopes[9].

Due to its relatively short half-life and 238U isobaric interference, 238Pu can hardly be measured by this method. To quantify this isotope, other techniques can be used (ICP-MS with collision-reaction cell, ICP-MS/MS with collision-reaction cell or chemical separation). Alpha spectrometry measurement, as described in ISO 13167[10], is currently used[11].

This method is applicable to all types of water having a saline load less than 1 g·l−1. A dilution of the sample is possible to obtain a solution having a saline load and activity concentrations compatible with the preparation and the measurement assembly.

A filtration at 0,45 μm is needed for determination of dissolved nuclides. Acidification and chemical separation of the sample are always needed.

The limit of quantification depends on the chemical separation and the performance of the measurement device.

This method covers the measurement of those isotopes in water in activity concentrations between around[12][13]:

— 1 mBq·l−1 to 5 Bq·l−1 for 239Pu, 240Pu and 237Np;

— 1 Bq·l−1 to 5 Bq·l−1 for 241Pu.

In both cases, samples with higher activity concentrations than 5 Bq·l−1 can be measured if a dilution is performed before the chemical separation.

It is possible to measure 241Pu following a pre-concentration step of at least 1 000.


Water quality — Gross alpha and gross beta activity — Test method using liquid scintillation counting

Qualité de l'eau — Activités alpha globale et bêta globale — Méthode d'essai par comptage des scintillations en milieu liquide

This document specifies a method for the determination of gross alpha and gross beta activity concentration for alpha- and beta-emitting radionuclides using liquid scintillation counting (LSC).

The method is applicable to all types of waters with a dry residue of less than 5 g/l and when no correction for colour quenching is necessary.

Gross alpha and gross beta activity measurement is not intended to give an absolute determination of the activity concentration of all alpha- and beta-emitting radionuclides in a test sample, but is a screening analysis to ensure particular reference levels of specific alpha and beta emitters have not been exceeded. This type of determination is also known as gross alpha and beta index. Gross alpha and beta analysis is not expected to be as accurate nor as precise as specific radionuclide analysis after radiochemical separations.

The method covers non-volatile radionuclides below 80 °C, since some gaseous or volatile radionuclides (e.g. radon and radioiodine) can be lost during the source preparation.

The method is applicable to test samples of drinking water, rain water, surface and ground water as well as cooling water, industrial water, domestic and industrial waste water after proper sampling and test sample preparation (filtration when necessary and taking into account the amount of dissolved material in the water).

The method described in this document is applicable in the event of an emergency situation, because the results can be obtained in less than 4 h by directly measuring water test samples without any treatment.

It is the laboratory's responsibility to ensure the suitability of this test method for the water samples tested.


Water quality — Gross beta activity — Test method using thick source

Qualité de l'eau — Activité bêta globale — Méthode d'essai par source épaisse

This document specifies a test method for the determination of gross beta activity concentration in non-saline waters. The method covers non-volatile radionuclides with maximum beta energies of approximately 0,3 MeV or higher. Measurement of low energy beta emitters (e.g. 3H, 228Ra, 210Pb, 14C, 35S and 241Pu) and some gaseous or volatile radionuclides (e.g. radon and radioiodine) might not be included in the gross beta quantification using the test method described in this document.

This test method is applicable to the analysis of raw and drinking waters. The range of application depends on the amount of total soluble salts in the water and on the performance characteristics (background count rate and counting efficiency) of the counter used.

It is the laboratory's responsibility to ensure the suitability of this method for the water samples tested.


Information technology — Universal coded character set (UCS)

Technologies de l'information — Jeu universel de caractères codés (JUC)

This document

specifies the architecture of the UCS;

defines terms used for the UCS;

describes the general structure of the UCS codespace;

specifies the assigned planes of the UCS: the Basic Multilingual Plane (BMP) of the UCS, the Supplementary Multilingual Plane (SMP), the Supplementary Ideographic Plane (SIP), the Tertiary Ideographic Plane (TIP), and the Supplementary Special-purpose Plane (SSP);

defines a set of graphic characters used in scripts and the written form of languages on a world-wide scale;

specifies the names for the graphic characters and format characters of the BMP, SMP, SIP, TIP, SSP and their coded representations within the UCS codespace;

specifies the coded representations for control characters and private use characters;

specifies three encoding forms of the UCS: UTF-8, UTF-16, and UTF-32;

specifies seven encoding schemes of the UCS: UTF-8, UTF-16, UTF-16BE, UTF-16LE, UTF-32, UTF-32BE, and UTF-32LE;

specifies the management of future additions to this coded character set.

NOTE The determination of suitability of these characters for use as identifiers in programming languages is not specified by this document but can be found in an external reference. See Annex U.


Road Vehicles - Test scenarios for automated driving systems - Qualification of Virtual Test Environments

Véhicules routiers — Scénarios d'essai pour les systèmes de conduite automatisée — Qualification des environnements d'essai virtuels


Graphical symbols — Safety colours and safety signs — Natural disaster safety way guidance system

Symboles graphiques — Couleurs de sécurité et signaux de sécurité — Système de guidage pour mise en sécurité en cas de catastrophe naturelle

This document specifies the principles governing the design and application of signs and plans used to create a natural disaster safety way guidance system to help people evacuate to safe areas or places of refuge in case of natural disasters (e.g. tsunamis, floods, debris flows, steep slope failures, landslides, tornados, large-scale fires, active volcanoes).

This document provides guidance on the selection and use of safety signs conforming to ISO 7010, public information symbols conforming to ISO 7001, and text on evacuation route signs, places of refuge signs and evacuation plan signs for information related to one or more particular natural disasters. Guidance on the design, location, mounting positions and maintenance of the sign components of a natural disaster safety way guidance system is also provided.

This document does not apply to the determination of the need for natural disaster safety way guidance. This document assumes that the risk assessment or requirements of an enforcing authority have established the need for such natural disaster safety way guidance systems.

This document is not applicable to the particular hazards of high winds, snow avalanches, earthquakes or hurricanes, which cause the natural disasters covered in this document.

This document is applicable to safety way guidance from natural disasters from the outside of buildings to safe areas. ISO 16069 is applicable to safety way guidance within a building to the emergency exit(s).


Water safety signs and beach safety flags — Part 3: Guidance for use — Amendment 1

Signaux de sécurité relatifs à l'eau et drapeaux de sécurité pour les plages — Partie 3: Lignes directrices pour l'utilisation — Amendement 1


Information technology — City data model — Part 4: Service level concepts for public health emergencies

This document defines an ontology for service level concepts for public health emergencies using terms specified in ISO/IEC 5087-1 and 5087-2.
Service level concepts are used to represent data that is shared across multiple services and stakeholders in the city. Service level concepts are distinguished by their data being read but not updated by multiple city services and stakeholders.


Digital imaging — Image flare measurement — Part 2: Angle dependent image flare

This International Standard specifies a measurement procedure and its visualization for image flare at various angles of incidence for incoming light.
The methods of measurement are designed to enable the assessment of the performance of digital cameras by using image data outputted by the digital cameras.
This standard does not specify the value for the allowable range for the image flare.


Health informatics – Identification of medicinal products (IDMP) — Part 1: Implementation guidelines for ISO 11238: General


Principle for operational rules for automated driving mode application on mainline

This document provides an overview of operational rules when automated driving mode is applied in mainline railway.

The overview describes the process, procedure and responsibility in operational activities which are affected by automated driving mode application in mainline railway. This document aims to describe the possible impacts on existing operational rules for systems not providing any automatic driving mode. This document covers the operational rules for automated driving mode of passenger train operation in semi-automated driving mode (GOA2) where the train driver is onboard. The situations of shunting, freight operation, and degraded mode are not covered. This document excludes electrical or mechanical requirements and technical aspects of systems providing automatic driving.

This document is not applicable to UGTS (Urban Guided Transport System).


Health informatics – Identification of medicinal products (IDMP) — Part 2: Implementation guidelines for ISO 11238: Chemical substances

Informatique de santé – Identification des médicaments — Partie 2: Lignes directrices pour·la·mise·en·œuvre de l'ISO 11238 : Substances chimiques


Health informatics – Identification of medicinal products (IDMP) — Part 3: ISO 11238 implementation guidelines Part 3: protein substances


Non-destructive testing — Penetrant testing and magnetic particle testing — Viewing conditions

Essais non destructifs — Contrôle par ressuage et contrôle par magnétoscopie — Conditions d'observation

ISO 3059:2012 specifies the control of the viewing conditions for magnetic particle and penetrant testing. It includes minimum requirements for the illuminance and UV-A irradiance and their measurement. It is intended for use when the human eye is the primary detection aid.

ISO 3059:2012 does not cover the use of actinic blue light sources.


Non-destructive testing — Penetrant testing — Part 3: Reference test blocks

Essais non destructifs — Examen par ressuage — Partie 3: Pièces de référence

ISO 3452-3:2013 describes two types of reference blocks: Type 1 reference blocks are used to determine the sensitivity levels of both fluorescent and colour contrast penetrant product families; Type 2 reference blocks are used for routine assessment of the performance of both fluorescent and colour contrast penetrant testing.

The reference blocks are to be used in accordance with ISO 3452-1:2013.


Geotechnical investigation and testing — Laboratory testing of rock — Part 3: Determination of the uniaxial compressive strength and deformability

Reconnaissance et essais géotechniques — Essais de laboratoire sur les roches — Partie 3: Détermination de la résistance à la compression uniaxiale et des paramètres de déformabilité

This document will specify methods for the determination of the uniaxial compressive strength and deformability.
This document is applicable to the laboratory determination of the uniaxial compressive strength and deformability of rock samples.
This document is part of the laboratory tests defined in the ISO 16 383 series.


Intelligent transport systems — Cooperative ITS — Using V2I and I2V communications for applications related to signalized intersections

Systèmes intelligents de transport — Coopérative ITS — Utilisation de communications V2I et I2V pour des applications relatives aux intersections signalées

This document defines the message, data structures, and data elements to support exchanges between the roadside equipment and vehicles to address applications to improve safety, mobility and environmental efficiency. In order to verify that the defined messages will satisfy these applications, a systems engineering process has been employed that traces use cases to requirements and requirements to messages and data concepts.

This document consists of a single document that contains the base specification and a series of annexes. The base specification lists the derived information requirements (labelled informative) and references to other standards for message definitions where available. Annex A contains descriptions of the use cases addressed by this document. Annexes B and C contain traceability matrices that relate use cases to requirements and requirements to the message definitions (i.e. data frames and data elements). The next annexes list the base message requirements and application-oriented specific requirements (requirements traceability matrix) that map to the message and data concepts to be implemented. As such, an implementation consists of the base plus an additional group of extensions within this document.

Details on information requirements, for other than SPaT, MAP, SSM, and SRM messages are provided in other International Standards. The focus of this document is to specify the details of the SPaT, MAP, SSM, and SRM supporting the use cases defined in this document. Adoption of these messages varies by region and their adoption can occur over a significant time period.

This document covers the interface between roadside equipment and vehicles. Applications, their internal algorithms, and the logical distribution of application functionality over any specific system architecture are outside the scope of this document.


Fine Ceramics (Advanced Ceramics, Advanced Technical Ceramics) — Determination of antiviral activity of semiconducting photocatalytic materials — Part 2: Test method using animal virus.

This document specifies the determination of the antiviral activity of materials that contain photocatalytic materials or have photocatalytic films on the surface, by measuring the infectivity of titre of virus after irradiation of ultraviolet light using the virus that can infect animal cells. Due to the individual sensitivities, the results of one test virus might not be applicable for other viruses.
This document is intended for use with different kinds of semiconducting photocatalytic materials used in construction materials, in flat sheet, board, or plate shape that are the basic forms of materials for various applications. It does not include powder, granular, or porous photocatalytic materials.
This document is applicable to photocatalytic materials produced for antiviral applications. Other types of performance of photocatalytic materials, i.e. antibacterial activity, antifungal activity, decomposition of water contaminants, self-cleaning, antifogging, and air purification, are not determined by this test method.
The values expressed in this International Standard are in accordance with the International System of
Units (SI).


Fine ceramics (advanced ceramics, advanced technical ceramics) — Determination of antiviral activity of semiconducting photocatalytic materials under indoor lighting environment — Part 2: Test method using animal virus.

This document specifies the determination of the antiviral activity of materials that contain indoor-light-active photocatalytic materials or have indoor-light-active photocatalytic films on the surface by measuring the infectivity titre of virus after illumination with indoor light using the virus that can infect animal cells. Due to individual sensitivities, the results of one test virus might not be applicable to other viruses.
This document is intended for use with different kinds of indoor-light-active photocatalytic materials used in construction materials, in flat sheet, board or plate shapes that are the basic forms of materials for various applications. It does not include powder, granular or porous indoor-light-active photocatalytic materials.
This document is applicable to indoor-light-active photocatalytic materials produced for an antiviral applications. Other types of performance of indoor-light-active photocatalytic materials, i.e. antibacterial activity, antifungal activity, decomposition of water contaminants, self-cleaning, antifogging and air purification, are not determined by this method.
The values expressed in this document are in accordance with the International System of Units. (SI)


Health informatics — Conceptual framework for patient findings and problems in terminologies

Informatique de santé — Cadre conceptuel pour les constats des patients et les problèmes de terminologies

The purpose of ISO/TS 22789:2010 is to specify a categorial structure, within the subject field of patient findings and problems, by defining a set of common domain constraints for use within terminological systems including a classification, coding scheme, coding system, reference terminology and clinical terminology.

Clinical findings are concepts that are recorded in clinical records and can describe any state observed directly or indirectly concerning a patient and their relationship with the environment. ISO/TS 22789:2010 is focused on a sub-population of these findings concerning in vivo descriptions of state (structure and function) directly related to the patient.

ISO/TS 22789:2010 describes a concept system detailing a domain constraint of sanctioned characteristics each composed of a semantic link and an applicable characterizing category.


Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers

Informatique de santé — Exigences relatives au codage international lisible par machine des identifiants de paquetage de médicaments

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.

This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).


Styrene-butadiene rubber, raw — Determination of soap and organic-acid content — Part 2: Qualitative analysis

Caoutchouc styrène-butadiène brut — Détermination de la teneur en savon et en acides organiques — Partie 2: Analyse qualitative

This document specifies a method for the qualitative analysis of the organic acids in raw emulsionpolymerization styrene-butadiene rubber (E-SBR) using a gas chromatograph combined with mass spectrometer (GC-MS).
It is applicable to the identification of fatty acids and rosin acids (including disproportionated rosin acids).
The determination of the soap and organic-acid content of raw styrene-butadiene rubber (SBR) is specified in ISO 7781:2017.


Robinetterie industrielle — Réducteur pour appareil de robinetterie

This document provides basic requirements for gearboxes to operate industrial valves for manual and automated on/off and modulating duties, this includes manual override gearboxes. It includes guidelines for classification, design and methods for conformity assessment.

It does not cover gear systems which are integral part in the design of valves and subsea gearboxes.

Other requirements or conditions of use different from those indicated in this document are agreed between the purchaser and the manufacturer or supplier (first party), prior to order.


Industrial valves — Part-turn actuator attachments

Robinetterie industrielle — Raccordement des actionneurs à fraction de tour

This document specifies requirements for the attachment of part-turn actuators, with or without gearboxes, to industrial valves.

The attachment of part-turn actuators to control valves in accordance with the requirements of this document is subject to an agreement between the supplier and the purchaser.

This document specifies:

—     flange dimensions necessary for the attachment of part-turn actuators to industrial valves [see Figures 1 a) and 1 c)] or to intermediate supports [see Figures 1 b) and 1 d)];

—     driving component dimensions of part-turn actuators necessary to attach them to the driven components;

—     reference values for torques for interfaces and for couplings having the dimensions specified in this document.

The attachment of the intermediate support to the valve is out of the scope of this document.


Industrial valves — Multi-turn actuator attachments

Robinetterie industrielle — Raccordement des actionneurs multitours

This document specifies the requirements for the attachment of multi-turn actuators to valves.

Throughout this document, “actuator” can be understood as “actuator and/or gearbox” providing a multi-turn and/or linear output.

It specifies:

—     flange dimensions necessary for the attachment of actuators to industrial valves [see Figure 1 a)] or to intermediate supports [see Figure 1 b)];

—     those driving component dimensions of actuators which are necessary to attach them to the driven components;

—     reference values for torque and thrust for flanges having the dimensions specified in this document.


Tyre classification — Agricultural, forestry and construction machines

Classification des pneumatiques — Machines agricoles, engins forestiers et engins de construction

ISO 18805:2017 specifies the classification codes for agricultural and forestry tractors and machines.


Water quality — Enumeration of Escherichia coli and coliform bacteria — Part 2: Most probable number method

Qualité de l'eau — Dénombrement des Escherichia coli et des bactéries coliformes — Partie 2: Méthode du nombre le plus probable

ISO 9308-2:2012 specifies a method for the enumeration of E. coli and coliform bacteria in water. The method is based on the growth of target organisms in a liquid medium and calculation of the "Most Probable Number" (MPN) of organisms by reference to MPN tables. This method can be applied to all types of water, including those containing an appreciable amount of suspended matter and high background counts of heterotrophic bacteria. However it must not be used for the enumeration of coliform bacteria in marine water. When using for the enumeration of E. coli in marine waters, a 1→10 dilution in sterile water is typically required, although the method has been shown to work well with some marine waters that have a lower than normal concentration of salts. In the absence of data to support the use of the method without dilution, a 1→10 dilution is used.

This method relies upon the detection of E. coli based upon expression of the enzyme b‑D‑glucuronidase and consequently does not detect many of the enterohaemorhagic strains of E. coli, which do not typically express this enzyme. Additionally, there are a small number of other E. coli strains that do not express b‑D‑glucuronidase.

The choice of tests used in the detection and confirmation of the coliform group of bacteria, including E. coli, can be regarded as part of a continuous sequence. The extent of confirmation with a particular sample depends partly on the nature of the water and partly on the reasons for the examination. The test described in ISO 9308-2:2012 provides a confirmed result with no requirement for further confirmation of positive wells.


Software and systems engineering — Software testing — Part 8: Model-based testing

Ingénierie du logiciel et des systèmes — Essais du logiciel — Partie 8: Titre manque

This standard provides requirements and guidelines on applying model-based testing (MBT) in accordance with the test processes defined in ISO/IEC/IEEE 29119-2. This document covers the following areas:
a)	Definitions for MBT
b)	Implementing ISO/IEC/IEEE 29119-2 for MBT
c) 	Implementing ISO/IEC/IEEE 29119-3 for MBT
Using MBT, the generation of testware is automated. This standard assumes that test execution is also automated. The implementation of the generation algorithm is tool dependent and therefore is out of the scope for this document. MBT tool selection is also out of the scope for this document.
The MBT models and the information generated by the supporting MBT tools can be used, in part or whole, to satisfy the documentation requirements of ISO/IEC/IEEE 29119-3. Many MBT tools implement one or more of the test techniques and associated measures defined in ISO/IEC/IEEE 29119-4. These techniques are associated with individual tool implementation and are outside the scope of this document.
This standard is applicable to model-based testing in all development lifecycle models.


Information technology — IT Enabled Services-Business Process Outsourcing (ITES-BPO) lifecycle processes — Part 6: Guidelines on risk management

Technologies de l'information — Processus du cycle de vie de la délocalisation du processus d'affaires des services activés par IT — Partie 6: Lignes directrices relatives au management du risque

This document provides guidance on risk management practices for the IT enabled services-business process outsourcing (ITES-BPO) service provider for the outsourced business processes. It provides guidance for planning, establishing, implementing, operating, monitoring, reviewing, maintaining and improving the risk management framework for the ITES-BPO services.

This document:

—    covers IT enabled business processes that are outsourced;

—    is applicable to the service provider;

—    is applicable to all lifecycle processes of ITES-BPO;

—    is not intended to cover IT services.

The guidelines in this document align to ISO 31000, elaborating the risk principles, risk management framework and risk management process from an ITES-BPO perspective.


Information technology — IT Enabled Services-Business Process Outsourcing (ITES-BPO) lifecycle processes — Part 7: Exemplar for maturity assessment

Technologies de l'information — Processus du cycle de vie de la délocalisation du processus d'affaires des services activés par IT — Partie 7: Titre manque

This document presents an exemplar for maturity assessment, following the framework for assessment of process capability levels and measurement of an organization's maturity level for an ITES-BPO service provider.

This document:

— uses the set of indicators for process performance and process capability;

— helps to collect the objective evidence that enables an assessor to determine the process ratings;

— helps to assess the result of the process capability level;

— serves as a measurement framework for processes and provides an organization maturity model for ITES-BPO organizations delivering the services;

— is useful for all users of the ISO/IEC 30105 series, including but not limited to internal assessors, external assessors, ITES-BPO service providers and ITES-BPO service customers;

— supports the performance assessment by providing a framework to measure and derive capability and organization maturity levels.


Information Technology - Governance of IT - Responsible governance of IT for digital inclusion


Information technology — Business operational view — Part 22: Framework for types of commitments in support of data interchanges in a business transaction


Information technology — Business operational view — Part 5: Identification and referencing of requirements of jurisdictional domains as sources of external constraints

Technologies de l'information — Vue opérationnelle d'affaires — Partie 5: Identification et référence des exigences de domaines juridictionnels en tant que sources de contraintes externes

ISO/IEC 15944-5:2008 is directed at being able to identify and reference laws and regulations impacting eBusiness scenarios and scenario components as external constraints. The primary source of such external constraints is jurisdictional domains.

ISO/IEC 15944-5:2008 focuses on addressing the simple, i.e. definable, aspects of external constraints for which the source is a jurisdictional domain. A useful characteristic of external constraints is that at the sectoral, national and international levels, etc. focal points and recognized authorities often already exist. The rules and common business practices in many sectoral areas are already known. Use of ISO/IEC 15944-5:2008 (and related standards) will facilitate the transformation of these external constraints (business rules) into specified, registered and reusable scenarios and scenario components.

The Business Transaction Model, explained in ISO/IEC 15944-1, has two classes of constraints, namely:

those which are self-imposed and agreed to as commitments among the parties themselves, i.e. internal constraints; and

those which are imposed on the parties to a business transaction based on the nature of the good, service and/or rights exchanged, and the nature of the commitment made among the parties (including ability to make commitments, the location, etc.), i.e. external constraints.

The focus of ISO/IEC 15944-5:2008 is on external constraints. Jurisdictional domains are the primary source of external constraints.

ISO/IEC 15944-5:2008 provides the key concepts required for addressing the legal environment in developing the Business Operational View of business transactions and scenarios which involve and are required to support external constraints.

It begins with an exploration of the jurisdictional domain as a source of external constraint on the business process, both from the perspective of a Person and as a Public Administration. It then presents key constraints governing ISO/IEC 15944-5:2008 through principles and rules.

It examines a key element in business transactions, that of the use of language. Jurisdictions can identify and, in some cases, impose the use of language in a business transaction. In this regard, the ISO/IEC 15944-5:2008 looks at the relationship of the constraint imposed by a jurisdictional domain on the choice of language used.

Public policy constraints are also examined and key requirements for their inclusion in external constraints are identified, especially where they can affect the modelling of Open-edi scenarios and the business transaction components of Persons, data and processes. In particular, there is a set of rules that govern the identification and categories of jurisdictional domains as individual states as well as sets of entities, both regional and international.

ISO/IEC 15944-5:2008 also focuses on the identification of rules governing the formation and identification of jurisdictional domains. It identifies the more primitive subtypes of jurisdictional domains and includes two approaches for the unambiguous identification of referencing of (subtypes of) jurisdictional domain.

ISO/IEC 15944-5:2008 also provides checklists, through the use of templates, to guide the user through the mechanics of determining the source of the external constraint(s) where these are jurisdictional domains and determining the adequacy of the scenario specification as well as those of the scenario components.

Annexes provide elaboration on the points raised in the main body.


Information technology — Metadata registries (MDR) — Part 3: Metamodel for registry common facilities — Amendment 1: Enhancements to Item Mapping

Technologies de l'information — Registres de métadonnées (RM) — Partie 3: Titre manque — Amendement 1: Titre manque


Information technology — Top level ontologies — Part 5: Unified Foundational Ontology (UFO)


Railway applications — Fire protection on railway vehicles — Part 3: Fire resistance requirements for fire barriers

Applications ferroviaires — Protection contre les incendies dans les véhicules ferroviaires — Partie 3: Exigences de résistance au feu des barrières au feu

This document specifies the fire resistance requirements and testing methods for fire barriers for railway vehicles.
The objective of the measures and requirements, specified in this document, is to protect passengers and staff in railway vehicles in the event of a developing fire on board.
Use of a Fire Containment and Control System, where permitted as an alternative to a fire barrier, is not in the scope of this document. It is not within the scope of this document to describe measures that ensure the preservation of the railway vehicles in the event of a fire.


Information technology — Database languages — GQL

Technologies de l'information — Langages de base de données — GQL

This document defines data structures and basic operations on property graphs. It provides capabilities for creating, accessing, querying, maintaining, and controlling property graphs and the data they comprise.

This document specifies the syntax and semantics of a data management language for specifying and modifying the structure of property graphs and collections thereof.

This document provides a vehicle for portability of data definitions and manipulation among GQL-implementations. Implementations of this document can exist in environments that also support application programming languages, end-user query facilities, and various tools for database design, data administration, and performance optimization.


Information technology — Data usage — Evaluation of data usage in organizations

This document establishes guidance for evaluating the capability of data usage in organizations. It specifies evaluation components, including preparation, indicator configuration, measurement approach and implementation.

The document is applicable to any organization to carry out its data usage capability evaluation.


Mechanical vibration — Measurement and evaluation of machine vibration — Part 1: General guidelines

Vibrations mécaniques — Mesurage et évaluation des vibrations de machines — Partie 1: Lignes directrices générales

ISO 20816-1:2016 establishes general conditions and procedures for the measurement and evaluation of vibration using measurements made on rotating, non-rotating and non-reciprocating parts of complete machines. It is applicable to measurements of both absolute and relative radial shaft vibration with regard to the monitoring of radial clearances, but excludes axial shaft vibration. The general evaluation criteria, which are presented in terms of both vibration magnitude and change of vibration, relate to both operational monitoring and acceptance testing. They have been provided primarily with regard to securing reliable, safe, long-term operation of the machine while minimizing adverse effects on associated equipment. Guidelines are also presented for setting operational limits.

NOTE 1 The evaluation criteria for different classes of machinery will be included in other parts of ISO 20816 when they become available. In the meantime, guidelines are given in Clause 6.

NOTE 2 The term "shaft vibration" is used throughout ISO 20816 because, in most cases, measurements are made on machine shafts. However, the ISO 20816 series is also applicable to measurements made on other rotating elements if such elements are found to be more suitable, provided that the guidelines are respected.

For the purposes of ISO 20816, operational monitoring is considered to be those vibration measurements made during the normal operation of a machine. The ISO 20816 series permits the use of different measurement quantities and methods, provided that they are well-defined and their limitations are set out, so that the interpretation of the measurements is well-understood.

The evaluation criteria relate only to the vibration produced by the machine itself and not the vibration transmitted to it from outside.

ISO 20816-1:2016 does not include consideration of torsional vibration.

NOTE 3 For torsional vibration, see, for example, ISO 3046‑5, ISO 22266‑1 or VDI 2039.


Mechanical vibration — Measurement and evaluation of machine vibration — Part 3: Industrial machinery with operating speeds between 120 r/min and 30 000 r/min

This document specifies the general requirements for evaluating the vibration of various coupled industrial machine types with a power above 15 kW and operating speeds between 120 r/min and 30 000 r/min when measurements are made in-situ. Guidelines for applying evaluation criteria are provided for measurements taken on non-rotating and rotating parts under normal operating conditions. The guidelines are presented in terms of both steady running vibration values and in terms of changes to vibration magnitude, which can occur in these steady values. The numerical values presented are intended to serve as guidelines based on worldwide machine experience, but shall be applied with due regard to specific machine features which can cause these values to be inappropriate. In general, the condition of a machine is assessed by consideration of both the shaft vibration and the associated structural vibration, as well as specific frequency components, which do not always relate to the broadband severity values presented.

The machine types covered by this document include:

a) steam turbines and generators with outputs less than or equal to 40 MW (see Note 1 and Note 2);

b) steam turbines and generators with outputs greater than 40 MW which normally operate at speeds other than 1 500 r/min, 1 800 r/min, 3 000 r/min or 3 600 r/min (although generators seldom fall into this category) (see Note 1);

c) rotary compressors;

d) industrial gas turbines with outputs less than or equal to 3 MW (see Note 2);

e) turbofans;

f) electric motors of any type, if the coupling is flexible. When a motor is rigidly coupled to a machine type covered by any other part of ISO20816, the motor may be assessed either against that other part or against ISO 20816-3;

g) rolls and mills;

h) conveyors;

i) variable speed couplings; and

j) blowers or fans (see Note 3).

NOTE 1   Land based steam turbines, gas turbines and generators of greater than 40 MW capacity, which run at 1 500 r/min, 1 800 r/min, 3 000 r/min or 3 600 r/min are covered by the requirements of ISO 20816-2. Generators in hydro-electric plants are covered by ISO 20816-5.

NOTE 2   Gas turbines of power greater than 3 MW are covered by ISO 20816-4.

NOTE 3   The vibration criteria presented in this document are generally only applicable to fans with power ratings greater than 300 kW or fans which are not flexibly supported. As and when circumstances permit, recommendations for other types of fans, including those of lightweight sheet-metal construction, will be prepared. Until these recommendations are available, classifications can be agreed between the manufacturer and the customer; using results of previous operational experience (see also ISO 14694).

Machinery including a geared stage can fall under the scope of this document. For performing acceptance tests of gearboxes please refer to ISO 20816-9.

The following types of industrial machine are not covered by this document:

k) land-based gas turbines, steam turbines and generators with power outputs greater than 40 MW and speeds of 1 500 r/min, 1 800 r/min, 3 000 r/min or 3 600 r/min (see ISO20816‑2);

l) gas turbine sets with power outputs greater than 3 MW (see ISO20816‑4);

m) machine sets in hydraulic power generating and pumping plants (see ISO20816‑5);

n) reciprocating machines and machines solidly coupled to reciprocating machines (see ISO10816‑6);

o) rotordynamic pumps and any integrated or solidly coupled electric motors where the impeller is mounted directly on the motor shaft or is rigidly attached to it (see ISO10816‑7);

p) reciprocating compressor systems (see ISO 20816-8);

q) rotary positive displacement compressors (e. g. screw compressors);

r) submerged motor-pumps; and

s) wind turbines (see ISO10816‑21).

The requirements of this document apply to in-situ broad-band vibration measurements taken on the shafts, bearings, bearing pedestals, or housings of machines under steady-state operating conditions within their nominal operating speed range. The requirements relate to both acceptance testing and operational monitoring. The evaluation criteria included in this document can be applied to both continuous and non-continuous monitoring situations.

The requirements of this document cover machines which can have gears or rolling element bearings, but do not address the diagnostic evaluation of the condition of those gears or bearings.

The requirements in this document are applicable only for the vibration produced by the machine set itself and not for vibration that is transmitted to the machine set from external sources.


Cycles — Safety requirements for bicycles — Part 1: Vocabulary

Cycles — Exigences de sécurité pour les bicyclettes — Partie 1: Vocabulaire

This document specifies terms and definitions related to safety and performance requirements for the design, assembly, and testing of bicycles and sub-assemblies having maximum saddle height 635 mm or more.

This document does not apply to specialized types of bicycle such as delivery bicycles, recumbent bicycles, tandems, BMX bicycles, and bicycles designed and equipped for use in severe applications such as sanctioned competition events, stunting, or aerobatic manoeuvres.

NOTE      For bicycles with a maximum saddle height of 435 mm or less, see national regulations for ride-on toys, and with a maximum saddle height of more than 435 mm and less than 635 mm, see ISO 8098.


Cycles — Safety requirements for bicycles — Part 2: Requirements for city and trekking, young adult, mountain and racing bicycles

Cycles — Exigences de sécurité pour les bicyclettes — Partie 2: Exigences pour bicyclettes de ville et tout chemin (trekking), jeunes adultes, tout-terrain et de course

This document specifies safety and performance requirements for the design, assembly, and testing of bicycles and sub-assemblies, and lays down guidelines for manufacturer’s instructions on the use and care of such bicycles.

This document applies to young adult bicycles with maximum saddle height of 635 mm or more and less than 750 mm, city and trekking bicycles, mountain bicycles, and racing bicycles that have a maximum saddle height of 635 mm or more including folding bicycles.

This document does not apply to specialized types of bicycle, such as delivery bicycles, recumbent bicycles, tandems, BMX bicycles, and bicycles designed and equipped for use in severe applications such as sanctioned competition events, stunting, or aerobatic manoeuvres.

NOTE      For bicycles with a maximum saddle height of 435 mm or less, see national regulations for ride-on toys, and with a maximum saddle height of more than 435 mm and less than 635 mm, see ISO 8098.


Cycles — Safety requirements for bicycles — Part 3: Common test methods

Cycles — Exigences de sécurité pour les bicyclettes — Partie 3: Méthodes d'essai communes

This document specifies the common test methods for ISO 4210‑2.


Cycles — Safety requirements for bicycles — Part 4: Braking test methods — Amendment 1

Cycles — Exigences de sécurité pour les bicyclettes — Partie 4: Méthodes d'essai de freinage — Amendement 1


Cycles — Safety requirements for bicycles — Part 4: Braking test methods

Cycles — Exigences de sécurité pour les bicyclettes — Partie 4: Méthodes d'essai de freinage

This document specifies the braking test methods for ISO 4210‑2.


Cycles — Safety requirements for bicycles — Part 5: Steering test methods

Cycles — Exigences de sécurité pour les bicyclettes — Partie 5: Méthodes d'essai de la direction

This document specifies the steering test methods for ISO 4210‑2.


Cycles — Safety requirements for bicycles — Part 6: Frame and fork test methods

Cycles — Exigences de sécurité pour les bicyclettes — Partie 6: Méthodes d'essai du cadre et de la fourche

This document specifies the frame and fork test methods for ISO 4210‑2.


Cycles — Safety requirements for bicycles — Part 7: Wheel and rim test methods

Cycles — Exigences de sécurité pour les bicyclettes — Partie 7: Méthodes d'essai des roues et des jantes

This document specifies wheel and rim test methods for ISO 4210‑2.


Cycles — Safety requirements for bicycles — Part 8: Pedal and drive system test methods

Cycles — Exigences de sécurité pour les bicyclettes — Partie 8: Méthodes d'essai des pédales et du système de transmission

This document specifies pedal and drive system test methods for ISO 4210‑2.


Cycles — Safety requirements for bicycles — Part 9: Saddles and seat-post test methods

Cycles — Exigences de sécurité pour les bicyclettes — Partie 9: Méthodes d'essai des selles et des tiges de selles

This document specifies saddle and seat-post test methods for ISO 4210‑2.


Cycles — Safety requirements for bicycles for young children

Cycles — Exigences de sécurité pour les bicyclettes pour jeunes enfants

This document specifies safety and performance requirements and test methods for the design, assembly and testing of fully assembled bicycles and sub-assemblies for young children. It also provides guidelines for instructions on the use and care of the bicycles.

This document is applicable to bicycles with a maximum saddle height of more than 435 mm and less than 635 mm, propelled by a transmitted drive to the rear wheel.

It is not applicable to special bicycles intended for performing stunts (e.g. BMX bicycles).

NOTE      For bicycles with a maximum saddle height of 435 mm or less, see national regulations for ride-on toys, and with a maximum saddle height of 635 mm or more, see ISO 4210-1 to ISO 4210-9.


Earth-moving machinery — Collision warning and avoidance — Part 5: Risk area and risk level for other forms of motion

This document defines requirements for collision warning (CWS) and collision avoidance systems (CAS) that address other forms of motion than forward/reverse and rotation for:
— earth-moving machinery as defined in ISO 6165,
— mobile underground mining machinery as defined in ISO 19296, rock drill rigs as defined in ISO 22935-5, and
— road construction machinery as defined in ISO 22242.
Clauses 5, 6, 7, and 8 do not consider machine height beyond that of height in travel position as established by machine manufacturer.
The requirements for  forward / reverse motion are stated in ISO 21815-3:2023 and for swing/rotation motion in ISO 21815-4:20XX.
This document covers
— collision warning and avoidance for articulation movement by speed reduction, stopping, or motion inhibit,
Note: Steering the machine whilst in forward/reverse motion is not considered as articulation motion.
— collision warning and avoidance for 4-wheel steer motion by speed reduction, stopping, or motion inhibit,
— collision warning and avoidance for motion of towed trailers in reverse by speed reduction, stopping, or motion inhibit,
— collision warning and avoidance for differential speed, skid turning, counter rotation motion by speed reduction, stopping, or motion inhibit,
—	collision warning and avoidance for telescopic extension/ retraction motions, and
—	collision warning and avoidance for vertical motions i.e. height or depth
For articulation this document considers
•	a stationary machine when an articulation command is given
•	during articulation, where no linear motion takes place (i.e. forward / reverse).
This document does not cover avoidance by automatic manoeuvring (e.g. steering) away from the object.
The system described in this standard is intended to assist the operator of the machine.   The responsibility for safe operation of the machine remains with the machine operator.
This document is not applicable to collision warning and collision avoidance systems installed or manufactured before the date of its publication.
Machines that are double articulated are excluded from the scope of this document.


Traditional Chinese medicine — Requirements for decoction pieces prescription

This document specifies the general requirements, content, and writing requirement for decoction pieces prescription. It regulates qualification of prescription writing, prescription of precious medicines, prescription of toxic and anesthetic medicines, and institution-based prescription, etc.


Requirements for the training of Citizen Science Divers

This standard specifies the requirements for the training of citizen science divers. The standard shall have a broad scope so as to be applicable to all disciplines of science.
This document is applicable to all recreational divers independent of any scientific background (unlike the ISO 8804 standard series which a primarily directed at the scientific diving community).

A citizen science diver is competent in basic underwater scientific methodologies and protocols and shall be able to assist in scientific diving activities.

This standard will specify competencies, prerequisites for training, Introductory information, Required theoretical knowledge, Required practical skills, Practical training parameters and Evaluation criteria for training systems aimed at training citizen science divers.


Use cases for green logistics activities


Orthopedic implants — Metallic bone screws — Requirements

This Document establishes the requirements for material, marking, finishing, care and handling, dimensions, sterilization, manufacturing, packaging, and acceptable tolerances, as well as establishes the performance requirements for metallic bone screws used as implants for osteosynthesis. This Document does not apply to implantable screws intended for the reconstruction or fixation of soft tissues, including suture anchors and interference screws. This Document does not apply to implantable screws intended for spine applications. However, the principles of this Document can be applied to these screws at user’s discretion.


Information and documentation — RFID in libraries — Part 3: Fixed length encoding

Information et documentation — RFID dans les bibliothèques — Partie 3: Encodage de longueur fixe

This document provides a data model and encoding rules for the use of radio frequency identification (RFID) tags for items appropriate for the needs of all types of libraries (including national, academic, public, corporate, special, and school libraries).

This document specifies the rules for encoding

—     a subset of data elements taken from the total set of data elements listed in ISO 28560-1 into a basic block, and

—     other data elements into extension blocks onto the RFID tag.

A source of additional information about implementation issues is provided in Annex A.


Fine ceramics (advanced ceramics, advanced technical ceramics) — Methods of tests for reinforcements — Determination of ceramic fibre density

This document specifies two methods for the determination of ceramic fibre density. These methods are applicable to both continuous and discontinuous ceramic fibre, including oxide and non-oxide ceramic fibre. Two methods are proposed for the determination of ceramic fibre density, as follows:
— Method A: buoyancy method.                                                                                — Method B: helium pycnometer method.


Thermal insulation products — Polyester fibre mat and board — Specification

This document provides the requirements for factory-made products of polyester fibre thermal insulation mat or board products for buildings. It includes determination of product characteristics covering procedures for evaluation of performance, conformity, marking, labelling and packaging.

This document is limited to man-made polyester fibre thermal insulation products containing more than 65% (by mass) of man-made polyester fibre, with or without facings. The product is used where the continuous service temperature of the insulation substrate is bounded by the temperature range −40 °C to + 110 °C.

Products covered in this document may also be used in prefabricated thermal insulation systems and composite panels; the performance of systems incorporating these products is not covered.

This document does not purport to address all the health and safety aspects associated with its use. Anyone using this Standard has the responsibility to consult the appropriate authorities and to establish health and safety practices, in conjunction with any existing applicable regulatory requirements, prior to its use.


Information Security — Oblivious Transfer

Sécurité de l'information — Transfert oblivieux

This document specifies terms, various parameters and properties related to oblivious transfer, and establishes a generic model of oblivious transfer.


Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

Biotechnologie — Banques biologiques — Exigences relatives aux cellules stromales mésenchymateuses humaines issues des tissus du cordon ombilical

This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport.

This document is applicable to all organizations performing biobanking of hUC-MSCs used for research and development.

This document does not apply to hUC-MSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use.

NOTE      International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.


Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

Biotechnologie — Bioprocédés — Exigences et considérations générales pour les systèmes d'équipement utilisés dans la fabrication de cellules à usage thérapeutique

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing, volume reduction, cell finish through cryopreservation for the storage of cells for therapeutic use.

This document provides guidance on the design, use and maintenance of equipment and equipment systems to both equipment suppliers and equipment users from aspects including the target parties, i.e. equipment supplier or equipment user, and phase of involved task, i.e. design, use or maintenance.

This document is applicable to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting equipment user requirements. It is applicable to devices used for the purpose of monitoring equipment status.

It does not apply to:

processing equipment for cells for therapeutic use used at the point of care;

devices used for analytical purposes;

biosafety cabinets, general cell culture equipment (such as CO2 incubators, etc.), and software to control multiple equipment systems or multiple unit operations.


Molecular biomarker analysis — Detection of animal-derived materials in foodstuffs and feedstuffs by real-time PCR — Part 12: Part 12: Atlantic salmon DNA detection method

Analyse de biomarqueurs moléculaires — Détection de matériaux d'origine animale dans les denrées alimentaires et les aliments pour animaux par PCR en temps réel — Partie 12: Titre manque

the qualitative detection of Atlantic salmon-specific DNA derived from foodstuffs and feedstuffs. It requires extraction of an adequate amount of PCR amplifiable DNA from the relevant foodstuffs and feedstuffs matrix and specific primer/probes unique for detection of Atlantic salmon material derived from Atlantic salmon (Salmo salar).