CEN - European Committee for Standardization

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

This document specifies the characteristics of wheels for all heavy rail track gauges.
This document applies to heavy rail vehicles and applies, in principle, to other vehicles such as urban rail vehicles. Five steel grades, ER6, ER7, ER8, ERS8 and ER9, are defined in this document.
NOTE 1   Steel grade ERS8 has been introduced in this document as an optimization of steel grades ER8 and ER9 due to contact fatigue (RCF), taking into account service feedback from Europe, for example, BS 5892-3 in force in the United Kingdom.
Some features are provided as a Category 1 or Category 2 function.
The requirements defined in this document apply to cylindrical bores. Most requirements also apply to wheels with tapered bores. Specific requirements for tapered bores (e.g. geometrical dimensions, etc.) are defined in the technical specification.
This document applies to monobloc wheels in vacuum degassed steel, forged and rolled, with surface treated rims, which have already been the subject of extensive commercial applications on a European network or have complied with a technical approval procedure according to EN 13979-1:2020 to validate their design.
Annex A describes the evaluation process for accepting new materials that are not included in this document.
This document defines the requirements to be met for wheels; the technical approval procedure is not part of the scope of this document.
NOTE 2   A "surface-treated rim" is achieved by heat treatment which aims to harden the rim and create compressive residual stress.

This document specifies a method of testing the laser-induced ignition and damage of medical beam delivery systems to allow checking of suitable products according to the classification system.
NOTE 1 Take care when interpreting these results, since the direct applicability of the results of this test method to the clinical situation has not been fully established.
NOTE 2 Users of products tested by this method are cautioned that the laser will be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other wavelengths, the power settings and modes of beam delivery need to be explicitly stated.
CAUTION — This test method can involve hazardous materials, operations and equipment. This document provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

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

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

1.1       This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE         Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a)      the radionuclide 60Co or 137Cs;
b)      a beam from an electron generator; or
c)       a beam from an X-ray generator.
1.2       This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE         For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1       This document does not specify requirements for designating a medical device as sterile.
NOTE         Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2       This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE         It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3       This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4       This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE         Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5       This document does not specify requirements for the sterilization of used or reprocessed devices.

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

This document specifies the safety rules for lifts permanently serving buildings and constructions and intended for the transport of persons or persons and goods. It applies to traction lifts, positive drive lifts and hydraulic lifts that:
serve specific levels; and
have a rated speed exceeding 0,15 m/s; and
have an enclosed car; and
move along guide rails inclined not more than 15° to the vertical; and
    are indoor or weather-protected.
This document also applies to the electrical equipment of these lifts including the lighting and socket outlets in the well.
This document specifies safety rules related to:
persons to be safeguarded:
users, including passengers, maintenance and inspection personnel;
persons at the landings and outside of the well, or any machinery space and pulley room, who can be affected by the lift.
property to be safeguarded:
loads in the car;
components of the lift installation;
building in which the lift is installed.
This document does not specify additional requirements for:
lifts serving buildings with requirements for seismic conditions;
lifts serving buildings with requirements for accessibility;
lifts exposed to vandalism;
lifts which can be used for firefighting and evacuation purposes under firefighters control;
lifts which can be used to support faster evacuation of persons with disabilities;
the behaviour of the lift when the control system of the lift receives a recall signal(s) in the event of fire in a building.
This document is not applicable to passenger and goods passenger lifts, which are installed before the date of its publication.

This document specifies for passenger lifts and goods passenger lifts:
the verification of door locking devices;
the verification of safety gears;
the verification of overspeed governors;
the verification of buffers;
the verification of safety circuits and SIL-rated circuits;
the verification of ascending car overspeed protection means;
the verification of unintended car movement protection means;
the verification of rupture valves and one-way restrictors;
the verification of suspension and compensation means;
the discard criteria for suspension means and sheaves;
the calculation of guide rails;
the calculation of rams, cylinders, rigid pipes and fittings;
the evaluation of the traction;
the evaluation of the safety factor on suspension means;
the pendulum shock tests;
the fault exclusion for electric and electronic components;
the design rules for SIL-rated circuits.
This document is not applicable to passenger lifts, goods passenger lifts or lift components, which are installed or manufactured before the date of its publication.

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

This document specifies technical safety requirements and measures to be adopted by persons undertaking the design, manufacture and supply of press brakes which are intended to work cold metal or material partly of cold metal but which can be used in the same way to work other sheet materials (e.g. cardboard, plastic, rubber, leather) and also referred to as machines.
NOTE 1        The design of a machine includes the study of the machine itself, taking into account all phases of the “life” of the machine mentioned in ISO 12100:2010, 5.4, and the drafting of the instructions related to all the above phases.
This document covers the following types of machines (see Annex J):
hydraulic press brakes;
hydraulic servo-drive press brakes;
screw servo-drive press brakes;
belt-spring servo-drive press brakes.
The requirements in this document take account of intended use, as defined in ISO 12100:2010, 3.23, as well as reasonably foreseeable misuse, as defined in ISO 12100:2010, 3.24. This document presumes access to the press brake from all directions, deals with all significant hazards during the various phases of the life of the machine described in Clause 4, and specifies the safety measures for both the operator and other exposed persons.
NOTE 2        All significant hazards means those identified or associated with press brakes at the time of the publication of this document.
This document can also be used as a guide for the design of press brakes which are intended to be integrated in a manufacturing system.
This document deals with all significant hazards, hazardous situations or hazardous events relevant to press brakes and ancillary devices (see Clause 4) when it is used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer. This document specifies the safety requirements for press brakes defined in Clause 3.
This document does not cover press brakes which transmit energy to impart beam motion by using pneumatic means or mechanical clutch or press brakes that use combination of technologies (e.g. combined hydraulic and screw servo-drive press brake or combined hydraulic servo-drive and screw servo-drive press brake).
This document does not cover machines whose principal designed purpose is:
sheet folding by rotary action;
tube and pipe bending by rotary action;
roll bending.
This document does not cover hazards related to the use of press brakes in explosive atmospheres.
This document is not applicable to press brakes which are manufactured before the date of its publication.
This document does not cover the safety aspect of equipment for automatic workpiece loading and unloading where provided. Guidance on how to take into account additional automatic loading and unloading equipment can be found in ISO 11161:2007.

This document is applicable to small floating working machines used for work in, over, or on, inland waters. This document specifies safety-related requirements and test methods.
This document specifies minimum requirements for small floating working machines with a length of < 10 m and a product of length, width and depth of less than 30 m3, with temporarily or permanently installed work equipment or machines used on inland waters.
These small floating working machines can be used for activities such as extraction work, lifting work, sampling, mowing and clearing work or comparable tasks.

This document specifies a general framework, including principles, requirements and guidance for assessing, measuring, monitoring and reporting on investments and financing activities in relation to climate change and the transition into a low-carbon economy. The assessment includes the following items:
the alignment (or lack thereof) of investment and financing decisions taken by the financier with low-carbon transition pathways, adaptation pathways, and climate goals;
the impact of actions through the financier’s investment and lending decisions towards the achievement of climate goals in the real economy, i.e. mitigation (greenhouse gas emissions) and adaptation (resilience);
the risks to owners of financial assets (e.g. private equities, listed stocks, bonds, loans) arising from climate change.
To support the financier’s assessment of the impact of investment and lending decisions, this document provides guidance for the financier on how to:
set targets and determine metrics to be used for tracking progress related to the low-carbon transition pathways of investees;
determine low-carbon transition and adaptation trajectories of investees;
document the causality or linkage between its climate action and its outputs, outcomes and impacts.
This document is applicable to financiers, i.e. investors and lenders. It guides their reporting activities to the following third parties: shareholders, clients, policymakers, financial supervisory authorities and non-governmental organizations.

This document specifies requirements for 8-strand braided ropes, for 12-strand braided ropes, and for covered rope constructions (single braid, double braid and multi-core construction) for general purpose made of high modulus polyethylene (HMPE), and gives rules for their designation.
Many different types and grades of HMPE fibre exist which are commonly used to produce rope products. This document does not apply to all variations in strength or product performance.

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

The CEN/TS 18212 series [4] specifies a generic framework for the establishment of requirements and their evaluation methodology for biometric products. The requirements depend on the biometric mode considered, and are adapted to each scenario, through the definition of a variety of application profiles.
The CEN/TS 18212 series [4] specifies the evaluation methodology, the individual TESTs, and the application profiles (with their particular requirements).
This document is focussed on face biometrics, and provides the specifics of this biometric mode for the application of all the specifications provided in parts 1 till 3 from CEN/TS 18212 series [4]. It also defines a set of application profiles, that detail the applicable TESTs, the evaluation parameters and the assessment criteria.
In detail, this document defines, for face biometric products:
-   general aspects of a face biometric product;
-   common resources needed for the evaluation;
-   each of the possible TESTs to be applied;
-   application profiles for different kinds of face biometrics products.
NOTE 1   National regulations and requirements can apply.
NOTE 2   Regarding biometrics for public sector applications, see also BSI TR 03121 [10] which can apply.
NOTE 3   For an overview of sectors addressed in the Cybersecurity Act, see Regulation (EU) 2019/881[11].
NOTE 4   This part defines all potential TESTs that could be applicable when evaluating the functionality of a biometric product using this biometric mode. It will be the relevant application profile (3.1.1), the one that will specify which of these TESTs are applicable.
The following topics are left out of the scope of this document:
-   Vulnerability assessment of the storage system used for the biometric reference/s.
-   Vulnerability assessment of communication protocols and interfaces dealing with the operation of the biometric product.
-   Evaluation of the performance of human operators in terms of identity proofing.
-   Validation of documents providing the biometric reference

This document specifies requirements and test methods for measuring the accuracy of electronic apex locators that are used to determine the apex location during endodontic treatment.

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

This document specifies the measurement of the determination of the static airflow resistance (see also References[1]and2) in a laminar flow regime, of porous materials for acoustical applications.

This document specifies the procedure for screening soils for selected elements using handheld or portable equipment for energy dispersive X-ray fluorescence spectrometry (ED-XRF). It covers the application of this screening method to obtain qualitative or semi-quantitative data to assist decisions on a sampling strategy for detailed assessment of soil quality employing laboratory analytical chemical methods.
NOTE 1        Screening methods generally provide qualitative or semi-quantitative concentration values that are indicative of concentration values, although occasionally they can give quantitative results under specific or limited conditions.
NOTE 2        The greater the effort applied to the pretreatment of soil samples, the better the analytical results that can be expected (see e.g. Reference [19]).
This document does not explicitly specify elements for which it is applicable, since the applicability depends on the performance of the apparatus and the objective of the screening. The elements which can be determined are limited by the performance of the instrument used, the concentrations of particular elements present in the soil, and the requirements of the investigation in terms of the minimum concentrations of concern (e.g. guideline value).
NOTE 3        The XRF measurements of As, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Sn, V and Zn were validated as described in Annex A.
NOTE 4        Annex B provides examples of when screening with a handheld ED-XRF spectrometer and a portable ED-XRF spectrometer can be useful.
This document does not provide guidance on how to use the equipment to provide quantitative data for use in detailed site assessments. This document does not cover how the results of multiple determinations are synthesized to address the objectives of an ED-XRF determination.

This document specifies the general requirements on procedures for the preservation, handling and storage of samples of sewage and waterworks sludge, suspended matter, marine sediments and freshwater sediments for either chemical, physical, radiochemical, hydrobiological or microbiological examination, or all, in the laboratory.
The procedures in this document are not applicable to dried samples of sludge, sediment and suspended matter.
NOTE            The storage conditions given do not necessarily apply for derived samples, e.g. sediment eluates or extracts.
This document is not applicable to samples intended for biotesting with ecotoxicological or biological assays (which is specified in ISO 5667-16[5]) nor intended for microplastics (which is specified in ISO 5667-27[7]).

This document is applicable to positive displacement refrigerant compressors for stationary and mobile refrigerating systems and heat pumps, hereafter called compressors.
It is applicable for compressors used in commercial and industrial appliances and with electrical energy supply including integral motors, up to 1 000 VAC and 1 500 VDC.
It is applicable to open drive, semi hermetic and hermetic motor compressors, which contain a positive compression function.
This document is not applicable to:
-   compressors used in household appliance for which EN IEC 60335-2-34 applies;
-   compressors using water or air as refrigerant;
-   compressors in vehicle air conditioning systems covered by a specific product standard, e.g. ISO 13043.
This document does not deal with requirements for emission of noise.
NOTE 1   Compressors for automotive comfort air conditioning systems can be developed according e.g. SAE J 639.
NOTE 2   Noise emission depends on the complete installation of the built-in compressors and the corresponding operating conditions.
For semi-hermetic and open drive compressors which include moving parts and for which the external envelope is primarily designed for mechanical loads, thermal loads (to limit the possible deformation due to temperature), stiffness of the structure (external mechanical loads and weight of the equipment), taking into account established safe industrial practice, it is considered that pressure is not a significant design factor.
Attached parts covering other functions e.g. oil separators, oil coolers, suction accumulators comply to EN 14276-1 or EN 13445-6 (cast iron) or EN 13445-8 (aluminium) or show compliance to the relevant European requirements. This is applicable also to shells for hermetic compressors either welded or with any kind of permanent joint.
Requirements for compressors used in explosive atmospheres are not covered by this document.
NOTE 3   For further guidance see EN 1127-1.
This document deals with significant hazards, hazardous situations and events relevant to compressors, when they are used as intended and under conditions for misuse which are reasonably foreseeable by the manufacturer (see Clause 4).
This document specifies safety requirements for the design, construction, manufacture and testing, documentation and marking of compressors, including integral accessories, e.g. shut-off valve, if necessary.
This document relates to the compressor itself which is to be incorporated in a refrigerating system.
This document is not applicable to compressors as specified in the scope which are manufactured before the date of publication.

This document specifies the standard cost coding system (SCCS) that classifies costs, work hours and quantities for the assets and operations associated with the oil and gas industries including lower carbon energy activities. This document covers all life cycle phases of the assets and operations.
The SCCS is applicable to:
cost estimation;
benchmarking;
cost monitoring and reporting;
collection of quantities, work hours and cost data;
exchange of cost data among organizations;
implementation in cost systems.
This document also provides a basis for the establishment of:
cost classification relevant to cost accounting rules, specific contractual agreements, local requirements for cost reporting to national bodies, government rules and tax regulations, authorization for expenditure, billing purposes, etc.;
unique project breakdown structures (e.g. work breakdown structures, contract breakdown structures and organizational breakdown structures) or asset breakdown structures (e.g. tag or system codes and area or module breakdown structures).
This document is intended for the following users:
operators or owners;
contractors;
vendors, manufacturers or suppliers;
authorities or regulatory bodies;
benchmarking companies;
consultants.

This document specifies requirements for the most important metrological and design characteristics of plain limit gauges of linear size.
This document defines the different types of plain limit gauges used to verify linear dimensional specifications associated with linear size.
This document also defines the design characteristics and the metrological characteristics for these limit gauges as well as the new or wear limits state maximum permissible limits (MPLs) for the new state or wear limits state for these metrological characteristics.
In addition, this document describes the use of limit gauges. It covers linear sizes of up to 500 mm.

This document defines technical criteria and control procedures which are satisfied by hollow sleepers and bearers used in ballasted track with Vignole rails. The hollow sleepers and bearers designed for ballasted track can also be used in ballastless track. In this case, the requirements are defined by the customer.

This document specifies the standard for the digital exchange of data between the disposition (i.e. registered Office) and the mobile waste and recycling collection units (revolving emptying system according to the EN 840 series and the EN 13071 series and refuse collection vehicles according to the EN 1501 series).
The technique of data transmission is not part of this document.

This document specifies coupling between handpieces and motors that are connected to dental units. For the purposes of this document, the couplings described in this document are not equipped with electronic terminal(s).
This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.

This document specifies a method of determining the ability of adhesive bonds to resist static load. It is applicable to adhesives used in load bearing timber structures.
It is applicable for the following applications:
a) for assessing the compliance of adhesives according to EN 301, EN 15425, EN 16254, EN 17334 and EN 17418;
b) for assessing the suitability and quality of adhesives for load-bearing timber structures;
c) for assessing the effect on the bond strength resulting from constant load at different climate conditions.
This method is intended primarily to obtain performance data for the classification of adhesives for load bearing timber structures according to their suitability for use in defined climatic environments.
This method is not intended to provide data for structural design and does not necessarily represent the performance of the bonded member in service.

This document specifies general methods, with suitable test conditions, for the determination of the ash of a range of plastics. The particular conditions chosen can be included in the specifications for the plastic material in question.
Particular conditions applicable to poly(alkylene terephthalate) materials, unplasticized cellulose acetate, polyamides and poly(vinyl chloride) plastics, including some specific filled, glass-fibre-reinforced and flame-retarded materials, are specified in ISO 3451-2, ISO 3451-3, ISO 3451-4 and ISO 3451-5.

This document defines and describes the concept of on-boarding of person identification data (PID) within a Wallet. The scope of this document includes cases where a natural person is the User in control of a Wallet. This includes a natural person who is in control of their own information, as well as natural persons who control information to represent another natural person or a legal person. This document considers a single set of PID attributes linked to a single Wallet Unit. This does not exclude the issuance of multiple PIDs representing the same set of PID attributes, e.g. batch issuance.
It also provides the general workflow, the roles and responsibilities at stake, and links the on-boarding with the Level of Assurance concept underpinning eIDAS [1];
The scope of this document includes cases where a natural person is the User in control of a wallet. This includes a natural person who is in control of their own data as well as natural persons who control data to represent another natural person or legal person.
EXAMPLE     If a natural person represents a legal person, the PID provider can issue a "representation PID" in an own Wallet Unit for representation purposes controlled by the natural person Wallet User. The "representation PID" is a kind of attestation which contains PID about the natural person (representative) and about the legal person (representee).
This document is limited to the on-boarding of an unique set of person identification data, complying with the legal provisions of eIDAS [1], in particular (1) issued in accordance with Union or National laws, and (2) conformant with the relevant implementing act [5].
The following aspects are out of scope of this document:
—   the on-boarding of person identification data within a Wallet where the User is a legal person;
—   other types of on-boarding, such as:
—   provisioning of person identification data after revocation, expiration or deletion;
—   addition of other Attributes (under the shape of attestations) in accordance with the requirement of Level of Assurance “High” which are not part of the set of person identification data but are part of the legal identity under National’s laws;
—   management of person identification data (deletion, update, etc.);
—   provisioning of person identification data which is not compliant with the relevant implementing act [5];
—   provisioning of a partial set of person identification data;
—   provisioning of supplemental set(s) of person identification data (multiple PIDs);

This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient.
This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
—     respiratory;
—     enteral;
—     limb cuff inflation;
—     neural;
—     intravascular or hypodermic;
—     other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE            Clause A.2 contains guidance or rationale for this Clause.

This document specifies requirements for oropharyngeal airways.
This document is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
This document is not applicable to supralaryngeal airways, which are covered by ISO 11712[1].
The requirements that are also applicable to other airway devices have been removed from this document as they now appear in the general airway device standard (ISO 18190).
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190).

This document specifies methods for the measurement of the thermal resistance and water-vapour resistance , under steady-state conditions, of e.g. fabrics, films, coatings, foams and leather, including multilayer assemblies, for use in clothing, quilts, sleeping bags, upholstery and similar textile or textile-like products.
The application of this measurement technique is restricted to a maximum thermal resistance and water-vapour resistance which depend on the dimensions and construction of the apparatus used (e.g. 2 m2·K/W and 700 m2·Pa/W respectively, for the minimum specifications of the equipment referred to in this document).
The test conditions used in this document are not intended to represent specific comfort situations, and performance specifications in relation to physiological comfort are not stated.

This document specifies procedures for the detection of a DNA sequence of a construct used to (genetically) enhance the growth of fish commonly found in aquaculture. The genetically modified AquAdvantage Atlantic salmon (Salmo salar) carries the construct expressing CS-GHc2 growth hormone and can be detected based on a real-time polymerase chain reaction (PCR) targeting either the border between the growth hormone coding sequence (CS-GHc2) of Oncorhynchus tshawytscha (Chinook salmon) and the antifreeze terminator (T-AFP) of (Macro-) Zoarces americanus (ocean pout), i.e. with the construct-specific method, or the border between the Atlantic salmon genomic DNA and the antifreeze promoter (P-AFP) of ocean pout, i.e. with the event-specific method. These methods can be applied to identify the genetically modified (GM) fish or for screening purposes.
This document is applicable for the analysis of DNA extracted from foodstuffs. It can also be suitable for the analysis of DNA extracted from other products such as feedstuffs. The application of these methods requires the extraction of an adequate amount of amplifiable DNA from the relevant matrix.

This document specifies the minimum requirements for the contents of the user manual for Automotive LPG propulsion systems fitted in road vehicles.
This document does not cover the user manual for forklift trucks or other industrial machinery.

This document establishes a classification for phenolic and aminoplastic polycondensation adhesives according to their suitability for use for load-bearing timber products in defined climatic exposure conditions, and specifies performance requirements for such adhesives for the factory manufacture or factory-like manufacturing conditions of load-bearing timber products only.
This document only specifies the performance of an adhesive for use in an environment corresponding to the defined conditions.
The performance requirements of this document are applicable to the adhesive only, not to the manufacturing timber products. This document does not cover the performance of adhesives for on-site gluing (except for factory-like conditions) or the production of wood-based panels, except solid wood panels, or modified and stabilized wood with considerably reduced swelling and shrinkage properties, e.g. acetylated wood, heat treated wood and polymer impregnated wood.
This document is primarily intended for use by adhesive manufacturers and for use in timber products bonded with adhesives, to assess or control the quality of adhesives. The requirements are applicable to the type testing of the adhesives. Production control activities are outside the scope of this document.
Adhesives meeting the requirements of this document are adequate for use in load-bearing timber products, provided that the bonding process has been carried out according to an appropriate product standard.

This document provides to ELT recyclers and producers of ELT derived materials an approach
to the compliance with the European CPL and REACH regulations.
This document provides a guidance to:
 Identify the relevant hazardous substances expected in ELT derived rubber (granulates and powders),
 Assess the hazardous classification of the material according the CLP regulation based on the expected concentration range of these substances,
 Support the REACH compliance of the materials.

This document specifies the maximum mass content of alloying elements and impurities in aluminium and aluminium alloy cast materials and articles designed to be in contact with foodstuff. It contains provisions for the demonstration of conformity of products with the present document.
NOTE   Materials include ingots and liquid metal. Articles are finished goods.

This document specifies the characteristics of grooved pins with half-length centre oval grooves (with closed ends), in steel and stainless steel, and with nominal diameter 1 mm to 25 mm.
These grooved pins are designed to fulfil the main following functions:
relative rotation of the assembled parts, and
positioning or guiding,
with an easy installation (due to its symmetrical shape) and a high level of pull-out resistance (due to the elastic fit behaviour of the pin).
The general requirements (including functional principles for grooved pins and assembly) are specified in ISO 13669.

This document specifies a method for determining the content of wet gluten and the gluten index for wheat flours (Triticum aestivum L. and Triticum durum Desf.) by mechanical means.
This document is directly applicable to flours. It is also applicable to common and durum wheat after grinding, if their particular size distribution meets the specification given in Table B.1.
NOTE            This document is related to ICC 137/1[7], ICC 155[8] and AACC Method 38-12.02[9].

This document reviews installation scenarios, available test methods and national legislations to be considered when determining the external fire performance of roofs with above roof PV systems.
The report also reviews the current partners and approvals in the planning, installation and operation/maintenance of above roof PV installations, together with their current responsibilities.

This document provides a workflow comprising experimental procedures and flaw detection algorithms aimed at locating flaws in parts produced during the powder bed fusion-laser-based (PBF-LB) process of metals. It emphasizes the use of coaxial photodiode-based in-situ monitoring and statistical and clustering machine learning algorithms, particularly for detecting lack of fusion-induced flaws. The workflow delineates setting thresholds for statistical detection and determining the number of clusters for machine learning algorithms, utilizing intentional seeded flaws in parts. Validation procedures are provided through computed tomography scanner data. Hardware limitations and considerations for multi-laser processes are addressed, with attention to potential issues.

This document is directly applicable to pulsed X-radiation with pulse duration of 0,1 ms up to 10 s. This range covers the whole range used in medical diagnostics at the time of publication. Some specifications can also be applicable for much shorter pulses; one example is the air kerma of one pulse. Such a pulse can be produced, e.g. by X-ray flash units or high-intensity femtosecond-lasers. Other specifications are not applicable for much shorter pulses; one example is the time-dependent behaviour of the air kerma rate. This cannot be measurable for technical reasons as no suitable instrument is available, e.g. for pulses produced by a femtosecond-laser.
This document specifies the characteristics of reference pulsed radiation for calibrating and testing radiation protection dosemeters and dose rate meters with respect to their response to pulsed radiation. At this point, it is only concerned with the characteristics of single pulses. Single pulses are the most difficult for dosemeters to measure. Determining the dose for repeated pulses is easier, but still more difficult than for continuous radiation, i.e. the performance of the dosemeters when measuring repeated pulses lies between these extremes. The radiation characteristics includes the following:
time-dependent behaviour of the air kerma rate of the pulse;
time-dependent behaviour of the X-ray tube high voltage during the pulse;
uniformity of the air kerma rate within a cross-sectional area of the radiation beam;
air kerma of one radiation pulse;
air kerma rate of the radiation pulse;
repetition frequency.
This document does not define new radiation qualities but uses those radiation qualities specified in existing ISO and IEC standards. Instead, this document gives the link between the parameters for pulsed radiation and the parameters for continuous radiation specifying the radiation qualities. It does not specify specific values or series of values for the pulsed radiation field but specifies only those limits for the relevant pulsed radiation parameters that are required for calibrating dosemeters and dose rate meters and for determining their response depending on the said parameters.
The pulse parameters with respect to the phantom-related quantities were determined using conversion coefficients according to ISO 4037 (all parts). This is possible as the radiation qualities specified in existing ISO and IEC standards are used.
A given reference pulsed X-ray facility is characterized by the parameter ranges over which the full specifications and requirements according to this document are met. Therefore, not all reference pulsed X-ray facilities can produce pulses covering the same parameter ranges.

This document specifies performance requirements for alternative core laminates intended for interior use, the core layer compositions of which are not covered by EN 438-3 [1], EN 438-4 [2], EN 438-5 [3], EN 438-6 [4] and EN 438-8 [5]. The core layer types (coloured core layer and metal reinforced core layer) are specified in this part of the EN 438 series.
NOTE   Regarding the test methods relevant to this document, see EN 438-2.

This document provides the information needed to assess the condition over time of a unionid population, and the level of information for assessing whether a plan or project may be detrimental to their future prospects. It provides guidance on methods for survey and monitoring unionid mussel populations and the environmental characteristics important for maintaining populations in favourable condition. The document is based on best practice developed and used by unionid mussel experts in Europe, and describes approaches that individual countries have adopted for survey, data analysis and condition assessment.
Standard methods for restoring populations are not within the scope of this document.

This document of the EN 12255 series specifies design principles and performance requirements for secondary and tertiary treatment of wastewater in biological fixed-film reactors at wastewater treatment plants for more than 50 PT.
Its primary application is for wastewater treatment plants for the treatment of domestic and municipal wastewater. It can also be applied for biodegradable industrial wastewater.
Biological fixed film reactors include rotating biological contactors (RBC), biological trickling reactors (BTR), moving bed biological reactors (MBBR), submerged medium reactors (SMR) and submerged media filters (SMF). Membrane bioreactors (MBR) and anaerobic processes are not within the scope.
Some of the systems using fixed film bacteria are enhanced activated sludge systems (hybrid systems). For such systems, EN 12255-6 also applies.
This document specifies fundamental information about typical systems and does not provide information about all available fixed film systems.

This Technical Report describes and makes transparent the standards set of the Components for BAC Control Loop used for electronic individual zone control equipment.
The CEN numbering shows the coverage of the subject and their relationship.

This document establishes a classification for one component polyurethane (PUR) adhesives according to their suitability for use in load-bearing timber products in defined climatic exposure conditions, and specifies performance requirements for such adhesives for the factory manufacture or factory-like manufacturing of load-bearing timber products only.
It also classifies “adhesive product lines” where all the products within the line have the same chemical composition except for a different amount of catalyst.
This document only specifies the performance of adhesives for use in an environment corresponding to the defined conditions.
The performance requirements of this document are applicable to the adhesives only, not to the manufactured timber products. This document does not cover the performance of adhesives for on-site gluing (except for factory-like conditions) or the production of wood-based panels, except solid wood panels, or modified and stabilized wood with considerably reduced swelling and shrinkage properties, e.g. acetylated wood, heat treated wood and polymer impregnated wood.
This document is primarily intended for use by adhesive manufacturers and for use in timber products bonded with adhesives, to assess or control the quality of adhesives. The requirements are applicable to the type testing of the adhesives. Production control activities are outside the scope of this document.
Adhesives meeting the requirements of this document are adequate for use in load-bearing timber products, provided that the bonding process has been carried out according to an appropriate product standard.
This document does not address the classification and use of adhesives in combination with the spraying of water before or during the bonding process; see informative Annex C of this document.
This does neither allow nor forbid the use of adhesives in combination with the spraying of water.