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Standardization Organization
ICS
Technical Committee
Directive
Mandate

This document complements the existing requirements of ISO/IEC 17021-1 for bodies providing audit and certification of quality management systems against ISO 19443.
NOTE       This document is recommended for use as a criteria document for accreditation, peer assessment or other audit processes.

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This second edition cancels and replaces the first edition (ISO 4172 :1981), clause 2 and subclause 4.3 of which have been technically revised. Specifies general rules for the preparation of working drawings intended for the field assembly of prefabricated structures for building and civil engineering works. Gives normative references, definitions, documentation, designation of prefabricated structural components.

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Establishes general requirements, thicknesses of lines, and the simplified representation of doors and windows. Describes the conventional representation, and gives arrow symbols. Annex A is for information only.

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This document specifies designations for filler materials for brazing on the basis of their chemical composition. The designation includes their solidus/liquidus temperatures. This document applies to the metallic part of filler materials used in brazing products, for example foils, wires, rods, pastes, flux-coated rods or wires and flux-cored rods or wires.

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IEC 63267-2-1:2024 defines a set of specified conditions for an enhanced macro bend of 50/125 µm, graded index multimode fibre optic connection that is maintained in order to satisfy the requirements of attenuation and return loss performance in a randomly mated pair of polished physically contacting (PC) fibres. An encircled flux (EF) compliant launch condition in accordance with IEC 61300-1, at an operational wavelength of 850 nm, is used for determination of performance grades, based on lateral fibre core offset, numerical aperture (NA) mismatch, and fibre core diameter (CD) variation. Fibre core angular offset is considered insignificant given the state-of-the-art and is excluded as a factor for attenuation estimation. Attenuation and return loss performance grades are defined in IEC 63267-1.

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This document specifies general requirements and corresponding test methods for a general range of non-cutting instruments in surgery.

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This document specifies how to extend the ISO 32000-2:2020 specification by adding extensions to the Encrypt dictionary and trailer dictionary to provide integrity protection to the encrypted PDF document. This document also ensures that extensions are fully backward-compatible. These extensions are intended for developers of software that creates PDF files (PDF writers), software that reads existing PDF files and (usually) interprets their contents for display (PDF readers), software that reads and displays PDF content and interacts with the computer users to possibly modify and save the PDF file (interactive PDF processors) and PDF products that read and/or write PDF files for a variety of other purposes (PDF processors). NOTE PDF writers and PDF readers are more specialized classifications of interactive PDF processors and both are PDF processors. This document does not specify the following: — specific processes for converting paper or electronic documents to the PDF file format; — specific technical design, user interface implementation, or operational details of rendering; — specific physical methods of storing these documents such as media and storage conditions; — methods for validating the conformance of PDF files or PDF processors; — required computer hardware and/or operating system.

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IEC 63267-2-2:2024 defines the dimensional limits of an optical interface for reference connections necessary to meet specific requirements for fibre-to-fibre interconnection of non-angled and angled polished multimode reference connectors intended to be used for attenuation measurements in the field or factory. Several grades of reference connections are defined in this document. The multimode reference connections are terminated to restricted IEC 60793-2-10 A1-OM2b to A1-OM5b fibre at the 850 nm band only. The geometrical dimensions and tolerances of the specified reference connections have been developed primarily to limit the variation in measured attenuation between multiple sets of two reference connectors, and therefore to limit the variation in measured attenuation between randomly chosen reference connectors when mated with connectors in the field or factory.

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This document describes a method for measuring the spatial resolutions, lateral and axial, of the Raman microscope.

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This document classifies flexible cellular rubber products known as sponge and expanded rubber. The base material used in their manufacture may be natural rubber, reclaimed rubber, synthetic rubber or rubber-like material, either alone or in combination. Thermoplastic rubbers are not included. This document does not apply to latex foam rubbers or shoe soling. This document covers vulcanized cellular rubber products that are manufactured by a moulding or continuous vulcanization process, i.e. hot air, microwave, infra-red, liquid curing medium (LCM), shearing-head vulcanization or a combination of two or more of these methods. Sheeting materials are covered by ISO 6916-1. In the case of conflict between the provisions of this document and those of the detailed specification or test method for a particular product, the latter takes precedence. Reference to the methods specifically states the desired test or tests.

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This choreographies document describes ordering between Buyer and Seller where the Buyer wants to reach an agreement with the Seller about an order. It describes a series of activities that govern communication between the parties and refers to the specifications where information and rules that apply are described.
The various possible behaviours of the Seller and Buyer subsequent to the first order communication are conveyed by variants of this choreography that are described in 5.2.
Previous activities (e.g. cataloguing) and subsequent activities (e.g. invoicing) are outside the scope of this document. If performed electronically, their implementation is covered by other choreographies.
The identifier of this choreographies document is EN 17016-1:2022.
How to claim conformance to this choreography is described in 5.2.3.

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ISO/TS 14265:2011 defines a set of high-level categories of purposes for which personal health information can be processed. This is in order to provide a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organizations, regional health authorities, jurisdictions, countries) as an aid to the consistent management of information in the delivery of health care services and for the communication of electronic health records across organizational and jurisdictional boundaries.
The scope of application of ISO/TS 14265:2011 is limited to Personal Health Information as defined in ISO 27799, information about an identifiable person that relates to the physical or mental health of the individual, or to provision of health services to the individual.

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New Work Item for the alignment of EN ISO/IEC 15421:2000 with  the identical adoption of ISO/IEC 15421:2010

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This document defines the detailed classification of marine fuels within class F (fuels). It is intended to be read in conjunction with ISO 8216-99. NOTE Class F for fuels was originally defined as part of the method of classification for petroleum products given in ISO 8681.

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This document establishes a practice for the proximate analysis of coal and coke. It is intended for general utilization by the coal industry to provide a basis for comparison of coals and coke and for the determination of fixed carbon.

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This document provides specifications on business processes for exchanging an electronic product catalogues (“catalogues”) as part of the business processes in the post-award area and pre-award area (partially), so that catalogues can serve as a basis for placing orders as well as evaluating tenders. The key aspects covered by this choreography specification:
• Processes for submitting catalogues from the selling to the buying side;
• Processes for submitting catalogue-related data as part of tendering processes.
Transaction used in the specified choreographies are out of scope. These transactions are specified in the related transaction specification on “Catalogue Transactions”.

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This document provides general requirements and recommendations on the principles, procedures, and methods for investigating incidents where there have been injuries, illnesses, damage to health, fatalities to consumers, damage to property or environmental damage related to the use of products, services or facilities by consumers.  
NOTE 1 These incidents can occur anywhere.
This document is applicable to any person or any organization of any size, whether it is public, private or community-based.
NOTE 2 This document is not limited to incidents while products, services or facilities are in use, but also includes incidents that occur when products, services or facilities are not in use, such as during transportation or storage by consumers.

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This document gives general guidance for the sampling and gas chromatographic analysis of compressor oil in biomethane or compressed natural gas (CNG). The compressor oil mass fraction is determined by sampling on coalescing filters under defined operational conditions (the two first cubic meters of gas referring to standard conditions, delivered at a refuelling station). Compressor oils are lubricants used in mechanical devices where the purpose is to reduce the volume and increase the pressure of gases for use in a variety of applications. The method is solely applicable to compressed gas (p>18 MPa). The compressor oil content is expressed as mass fraction. The scope of this method is from 3 mg/kg – 30 mg/kg.

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This document establishes unambiguous abbreviated terms for commonly used rubber compounding ingredients of known, specific chemical composition.

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This document provides guidance for the definition, implementation, evaluation, and improvement of the measurements necessary to effectively manage innovation activities in an organization. It establishes the fundamentals of innovation operation measurements and guides their application towards four areas: — measurements for establishing and launching innovation initiatives; — measurements for innovation processes; — measurements for innovation initiatives; — measurements of innovation portfolios. This document is applicable to: — organizations that are seeking to define and implement an innovation operations measurement approach; — organizations and interested parties seeking to improve the areas of accountability, transparency, and evidence-based assessment of innovation operations; — customers, investors, and other interested parties, seeking confidence in the organization’s innovation operations management and its results; — providers of training in innovation operations and measurements, including assessment of and consultancy for achieving results; — experts in innovation operations evaluation and impact assessment, favoring the use of a harmonized international guidance standard; — innovation policy makers and program managers who are looking to obtain evidence of progress and desired outcomes of innovation activities supported through public policies and programs. All of the guidance provided within this document is generic and intended to be applicable to: — all types of organizations regardless of sector or size, whether they be private, public, not-for-profit, governmental or societal; — all types of innovations (e.g. product, service, process, model, and method) ranging from incremental to radical; — all types of time horizons, from short-term to long-term evaluation and measurement.

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This document specifies requirements and information for inclusion in the owner’s manual of small craft to enable the owner/operator to use the craft safely.

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This document specifies the minimum requirements for lubricants for turbines, as delivered. It is intended to be used in conjunction with ISO 6743-5. This document specifies the requirements for a wide variety of lubricants for the lubrication of most types of turbines for power generation, including steam turbines, gas turbines, single shaft combined cycle turbines with common lubrication system and hydraulic turbines. This document does not specify the requirements for lubricants for wind turbines, which are covered in ISO 12925-1. The following lubricants are considered: — mineral oils, of either API groups I, II, II+, III, including group III from GTL (gas to liquid) process, and III+. Some API groups II and III are suitable for high temperature gas turbines; — synthetic lubricants, esters (API group V) and polyalphaolefins (API group IV), intended for high temperature gas turbines; — synthetic lubricants, esters (API group V) and polyalphaolefins (API group IV), environmentally acceptable for use in hydraulic turbines; — fire resistant phosphate-ester type lubricants.

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This document specifies the characteristics of three-pole circuit breakers, temperature compensated with a rated current from 1 A to 25 A, used in aircraft on-board circuits at a temperature between −55 °C and 125 °C for ratings ≤ 15 A and −55 °C to 90 °C for ratings > 15 A and at an altitude of 22 000 m max.
These circuit breakers are operated by a push-pull type single pushbutton (actuator), with delayed action “trip-free” tripping.
They will continue to function up to the short-circuit current.

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This part of the EN 13523 series specifies a procedure for the comparative evaluation of resistance to soiling of an organic coating on a metallic substrate (coil coating) in an outdoor exposure environment, particularly the soiling defect known as "Tiger stripes".

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This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies to
—     dialysis fluids used for haemodialysis and haemodiafiltration,
—     substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
—     the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
—     sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
—     systems for continuous renal replacement therapy that use pre-packaged solutions, and
—     systems and solutions for peritoneal dialysis.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.

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1.1   This document specifies the constructional requirements for fans constructed to Group II G (of explosion groups IIA, IIB and hydrogen) categories 1, 2 and 3, and Group II D categories 2 and 3, intended for use in explosive atmospheres.
NOTE 1   Operation conditions for the different categories of fans used in this document are defined in Clause 4.
1.3   This document specifies requirements for design, construction, testing and marking of complete fan units intended for use in potentially explosive atmospheres in air containing gas, vapour, mist and/or dusts. Such atmospheres can exist inside (the conveyed atmosphere (flammable or not)), outside, or inside and outside of the fan.
This document covers mechanical equipment, in particular fans. The “type of protection” as specified in EN ISO 80079 37:2016 is constructional safety.
1.4   This document is applicable to fans working in ambient atmospheres and with normal atmospheric conditions at the inlet, having
—   absolute pressures ranging from 0,8 bar to 1,1 bar,
—   and temperatures ranging from −20 °C to +60 °C,
—   and maximum volume fraction of 21 % oxygen content,
—   and an aerodynamic energy increase of less than 25 kJ/kg.
NOTE 1   25 kJ/kg is equivalent to 30 kPa at inlet density of 1,2 kg/m3.
This document can also be helpful for the design, construction, testing and marking of fans intended for use in atmospheres outside the validity range stated above or in cases where other material pairings need to be used. In this case, the ignition risk assessment, ignition protection provided, additional testing (if necessary), manufacturer's marking, technical documentation and instructions to the user, clearly demonstrate and indicate the equipment's suitability for the conditions the fan can encounter.
NOTE 2   Temperatures below −20 °C can be considered. Material suitability can require specific evaluation for these temperatures. With lower temperature the explosion pressure increases, which leads to increased test pressures (see A.3) and can require specific testing. Although the standard atmospheric conditions in EN ISO 80079 36:2016 give a temperature range for the atmosphere of −20 °C to +60 °C the normal ambient temperature range for the equipment is −20 °C to +40 °C unless otherwise specified and marked.
1.5   This document does not apply to:
—   group I fans (fans for mining);
—   explosion group IIC (other than hydrogen);
—   category 1D fans;
—   cooling fans or impellers on rotating electrical machines;
—   cooling fans or impellers on internal combustion engines, vehicles or electric motors.
NOTE 3   Measures for category 1D fans are given in EN 1127 1:2019.
NOTE 4   Measures for explosion group IIC (other than hydrogen) are given in EN 1127 1:2019.
NOTE 5   Measures for explosion group I are given in EN ISO/IEC 80079 38:2016 and EN 1127 2:2014.

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This document specifies the functional requirements that build on ISO 21378 for audits in the areas of customs duties and indirect taxes [e.g. value-added tax (VAT) and excise duties]. It addresses how tax auditors obtain audit data for these audits, including data element formats and to some extent content requirements. In practice, this document applies to virtually every step in the whole process in the supply chain and covers both goods, services and works. It includes domestic transactions, cross-border transactions (import and export) and can cover both third-party and intercompany transactions or even movements of goods within the same company. This document does not describe when an event is taxable nor how to calculate tax or customs duties as this is legislation-specific and the situation can vary from country to country or even within the same country. This document covers standard exchange of the data related to taxable operations/activities by businesses to perform controls and audits more effectively and efficiently through automated tests. This document focuses on the characteristics related to taxability and the related formalities of the indirect tax and customs duties regulations. It includes the result of a tax calculation, the relevant underlying parameters which can be processed by ERP-systems and/or indirect tax/customs duties systems, and data needed to comply with indirect tax and customs duties legislation and formalities. This document is not designed to collect audit data from the regulators like tax and/or customs authorities.

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This document provides Product Category Rules (PCR) for the declaration of the Sustainability of RTNRDs according to EN 15804:2012+A2:2019.

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This part of the EN 13523 series specifies the basic principles and procedure for determining the resistance of an organic coating on a metallic substrate (coil coating) to a combination of fluorescent UV radiation, and water condensation and temperature under controlled conditions.
Due to varied conditions which occur during natural weathering and the extreme nature of accelerated testing, correlation between the two cannot be expected.
Not all organic coatings will perform on an equal basis but a degree of correlation between the same generic type might be observed.

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This document specifies the procedures for determining the dry-film thickness of an organic coating on a metallic substrate (coil coating).
Five appropriate methods are given in this document:
a)   magnetic induction;
b)   eddy current;
c)   micrometer;
d)   optical;
e)   ruggedized optical interference.
The methods are applicable only to products with smooth and flat substrates, but the coating itself can be textured. In that case, for methods a) and b), the average of a series of readings will represent an average of the thickness of the organic coating, while method c) will give the maximum thickness, method d) can provide the minimum, maximum and average thickness, and e) will give the total thickness.
Non-destructive continuous-web methods on measurement of dry-film thickness are only applicable on method a).

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This part of The EN 13523 series specifies the procedures for determining the resistance to salt spray (fog) of an organic coating on a metallic substrate (coil coating).
For steel, neutral salt spray (fog) is usually used, and for aluminium, acetic acid salt spray (fog).

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This document specifies a method to determine the amount of colour transferred from the surface of coloured leather to other surfaces by rubbing.
Two tests are carried out, one with a dry rubbing cloth and one with a wet rubbing cloth.
The method is applicable to all types of coloured leather. Since after‑treatments of the leather as well as surface finishes can affect the degree of colour transfer, the test can be made before and/or after such treatments.

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This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
—     concentrates in both liquid and powder forms;
—     additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;
—     equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
This document does not apply to:
—     concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;
—     pre-packaged and sterile dialysis fluid;
—     sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;
—     equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.

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This document specifies requirements for the additive manufacturing of metallic parts with directed energy deposition (DED) in the aerospace industry.
Within the application scope of this document, wire is used as feedstock, and arc processes (gas-shielded metal arc processes (MIG/MAG/GMAW), tungsten inert gas processes (TIG/GTAW), plasma arc processes (PAW)) are used as the main energy source.
This document is to be used in conjunction with the engineering documents, if required by the engineering authority.
This document does not address health and safety issues.

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This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.
This document is applicable to
—     water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and
—     water used in the preparation of concentrates.
This document does not apply to dialysis fluid regenerating systems.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.

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This document specifies the procedure for determining the difference in the colour of an organic coating on a metallic substrate by visual comparison against a standard using either diffuse natural daylight or artificial daylight in a standard booth.
NOTE   Results can differ between natural and artificial daylight.
It might be that two colour specimens will match in daylight but not under another light source. This phenomenon is known as metamerism (see EN 13523 3).
If a metameric match is to be reported in objective terms, spectrophotometric measurements (using CIE Standard Illuminants D65 and A) can be made, in accordance with EN 13523 3.
No statement is made about either the precision or the accuracy of this procedure since the results derived are neither in numerical form nor do they provide a pass/fail evaluation in objective terms. Therefore, this procedure is only intended to be used where the use of colour measuring instruments is not recommendable (evaluation of colour matches, inspection of metallic colours, etc.).
The standardization of such visual comparisons, by light sources, illuminating and viewing geometry and specimen size, provides for improved uniformity of results. This practice is essential for critical colour matching and is highly recommended for colour inspections.

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This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.

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This document specifies a method for sampling, extracting and preserving collembolans and mites from field soils as a prerequisite for using these animals as bio-indicators (e.g. to assess the quality of a soil as a habitat for organisms). The sampling and extraction methods of this document are applicable to almost all types of soils. Exceptions can be soils from extreme climatic conditions (hard, frozen or flooded soils) and other matrices than soil, e.g. tree trunks, plants or lichens.

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This document specifies procedures for determining the instrumental colour difference (CIELAB   or  ) of an organic coating on a metallic substrate compared to another one used as a reference (usually called reference) and the metamerism depending on the illuminant.
When two colour specimens have identical spectral reflectance curves, they are matching under any illuminant irrespective of its spectral characteristics. This is termed a “spectral match”. It is also possible for two colour specimens having different spectral reflectance curves to match visually under a given light source but not to match under another light source with different spectral characteristics; such matches are termed "metameric".
One quantitative description of metamerism is the so-called "metamerism index".
Information on the metamerism index is of limited value where ΔE (instrumental colour difference for a given illuminant) is > 0,5. The metamerism index is not suited for determining the absolute colour difference or colour consistency of a given specimen at change of illuminant.
The colour difference under the reference illuminant is to be measured in colour coordinates L*, a* and b*.
Excluded from this method are organic coatings producing fluorescence and/or which are multicoloured, pearlescent or metallic.
Establishing a reference as well as the magnitude of an acceptable colour difference are not covered by this method.
Two methods are given in this document:
a)   instrumental colour difference measurement using a tristimulus colourimeter;
b)   instrumental colour difference measurement using a spectrophotometer or equivalent.
It is advised that care is taken when measuring e.g.
-   textured surfaces;
-   fluorescent coatings;
-   metameric coatings;
-   multi-coloured, pearlescent, metallic or special colour effect coatings.

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This document specifies the procedure for determining the resistance of an organic coating on a metallic substrate to penetration by scratching with a needle.
It is possible that with some aluminium alloys and thin gauge steel substrate below 0,4 mm, that rather than scratching, the needle will deform the substrate. Under these conditions, this test method is not applicable.
Soft coatings such as poly vinyl chloride (PVC) and structured coatings will not give a precise result due to the soft nature of the coating and/or the potential for the needle to snag.
The method is not applicable to conductive coatings.

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This document specifies the minimum requirements for rubber hoses used for transferring ammonia, in liquid or in gaseous form, at ambient temperatures from −40 °C up to and including +55 °C at a working pressure of 2,5 MPa (25 bar). It does not include specifications for end fittings and is limited to the performance of the hoses and hose assemblies.

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This document specifies the syntax and semantics (SynSem) module of the lexical markup framework (LMF), a metamodel for representing data in monolingual and multilingual lexical databases used with computer applications. The SynSem module allows for the description of specific syntactic and semantic properties of lexemes, as well as the complex interactions between them. More specifically, the syntax part of the module describes the properties of a lexeme when combined with other lexemes in a sentence. When recorded in a lexicon, these properties make up the syntactic description of a lexical entry instance. The semantics part of the module, on the other hand, describes the sense of a lexeme and its relationship with other senses belonging to the same language. The SynSem interface describes the predicates and the mapping between syntactic and semantic arguments. This serialization covers the classes of ISO 24613-1 (Core model), ISO 24613-2 (Machine-readable dictionary (MRD) model) and ISO 24613-4 (TEI serialization).

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