Yhteinen Toimialaliitto

 

This European Standard specifies a method for testing the resistance of domestic articles made from ceramic, glass, glass ceramic, vitreous enamel, metal and plastics under the combined chemical, thermal and mechanical stresses of mechanical dishwashing in domestic dishwashers. It specifies a reference test method for domestic dishwashing only. It does not define the number of dishwashing cycles which any given product shall withstand.

 

This document provides general terms and definitions for systems, products and services as used in standards related to the railway applications. Excluded from the scope of this document are terms and definitions related to those electrotechnical and electronic products and services for railways which are within the scope of standards of IEC/TC 9.

 

This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.

 

This document specifies expected field loads for functions provided by the braking system actuator and modulator and applies to passenger cars and light commercial vehicles (classes M1 and N1, according to UNECE). Functions addressed in this document are: This document only covers functions where data of appropriate maturity are available. There are additional functions of a braking system, which are not covered by this document. By describing the expected field loads, this document specifies representative manoeuvres and occurrences for different functions. These serve as an orientation for the derivation of test procedures. This document applies to vehicles up to conditional automation (SAE J 3016 level 3).

 

This document specifies the test suite structure (TSS) and test purposes (TP) to evaluate the conformity of on-board equipment (OBE) and roadside equipment (RSE) to ISO 13141. It provides a basis for conformance tests for dedicated short-range communication (DSRC) equipment to support interoperability between different equipment supplied by different manufacturers. ISO 13141 specifies requirements for the localization augmentation communication (LAC) interface level, but not for the RSE or OBE internal functional behaviour. Consequently, tests regarding OBE and RSE functional behaviour remain outside the scope of this document.

 

This document specifies methodologies for calculation of braking performance for railway rolling stock and is applicable to all countries. This document describes the general algorithms/formulae using mean value inputs to perform calculations of braking performance in terms of stopping/slowing distances, stationary braking, power and energy for all types of rolling stock, either as single vehicles or train formations, with respect to the braking distance. The calculations can be used at any stage of the development and assessment process (design, manufacturing, testing, verification, investigation, etc.) of railway rolling stock. This document does not set out specific acceptance criteria (pass/fail). This document is not intended to be used as a design guide for selection of brake systems and does not specify performance requirements. This document contains examples of the calculation of braking forces for different brake systems and calculation of stopping distance and stationary braking relevant to a single vehicle or a train. This document does not provide a method to calculate the extension of stopping distances when the level of available wheel/rail adhesion is exceeded (wheel slide activity).

 

This document defines the specific technical railway requirements for running of machines and other vehicles used for construction, maintenance and inspection of track, structures, track formation and fixed electric traction equipment. Special national conditions applicable to specific member states are shown in Annex B. This document applies to all railbound machines and other vehicles - referred to as machines - running exclusively on the railway (utilizing adhesion between the rail and wheels) and used for construction, maintenance and inspection of track, structures, infrastructure and fixed electric traction equipment. This document applies to machines that are intended to operate signalling and control systems. NOTE Other rail mounted railway maintenance and infrastructure inspection machines are dealt with in other European Standards, see Technical Report CEN/TR 17498:2020. This document is written for 1 435 mm nominal track gauge; special requirements can apply for running on infrastructures with narrow gauge or broad gauge lines, urban railways, railways utilizing other than adhesion between the rail and wheels and road-rail machines which are not included in this standard. This document covers the railway specific requirements for movements of the machine as a train and movements to reach work sites. This document applies to equipment and systems which are operational on machines in running mode.

 

This document applies to railbound machines and other vehicles - referred to as machines - working exclusively on the railway (utilizing friction adhesion between the rail and rail wheels) but including machines that in working position are partly supported on the ballast or the formation and used for construction, maintenance and inspection of track, structures, infrastructure and fixed electric traction equipment. This document applies to machines that are intended to operate signalling and control systems. NOTE 1 Other rail mounted railway maintenance and infrastructure inspection machines are dealt with in other European Standards, see Technical Report CEN/TR 17498:2020. This document specifies the significant hazards, hazardous situations and events common to rail bound machines and arising due their use on railways when they are used as intended or under conditions of misuse which are reasonably foreseeable, see Clause 4. This document specifies the common hazards, in normal circumstances, during running, assembly and installation, commissioning, use (including setting, programming, and process changeover), operation, cleaning, fault finding, maintenance and de-commissioning of the machines. Additional safety measures can be required by exceptional circumstances, such as extreme ambient temperatures highly corrosive or contaminating environment; e.g. due to the presence of chemicals, and potentially explosive atmospheres. NOTE 2 This document covers the essential health and safety requirements connected to the use of railbound machines as outlined in the Machinery Directive. This document does not apply to the following: - requirements for quality of the work or performance of the machine; - use of separate equipment temporarily mounted on machines; - operation subject to special rules, e.g. potentially explosive atmospheres; - hazards due to natural causes, e.g. earthquake, lightning, flooding; - working methods; - operation in severe working conditions requiring special measures, e.g. corrosive environments, contaminating environments, strong magnetic fields; - hazards occurring when used to handle suspended loads which may swing freely; - autonomous mobile machines. NOTE 3 Autonomous mobile machines are referred to as ‘autonomous mobile machinery’ in the Machinery Regulations 3.1.1 c).

 

1.1 General This document defines the specific technical railway requirements for travelling and working with railbound machines and other vehicles - referred to as machines - used for construction, maintenance and inspection of track, structures, track formation and fixed electric traction equipment as specified in prEN 14033 1:2024. This document applies to all machines working exclusively on the railway (utilizing adhesion between the rail and rail wheels) and used for construction, maintenance and inspection of track, structures, infrastructure and fixed electric traction equipment. This document applies to machines that are intended to operate signalling and control systems. NOTE Other rail mounted railway maintenance and infrastructure inspection machines are dealt with in other European Standards, see Technical Report CEN/TR 17498:2020. This document is applicable to 1 435 mm nominal track gauge. Some requirements may be applicable for working on infrastructures with nominal narrow track gauge or nominal broad track gauge lines, tramways, railways utilizing other than adhesion between the rail and rail wheels and underground infrastructures. This document covers the safety requirements for the railway specific problems for travelling and working on different infrastructures. The application of these requirements will be the subject of a verification procedure, which is not part of this document. Annex I is included for information for the potential content of a verification procedure. In all cases an authorization to work is needed to access the infrastructure. This document is also applicable for machines that in working position are partly supported on the ballast or the formation. This document does not apply to: - the requirements with regard to the quality of work, including the related measuring methods, and the performance of the machine; ) - the specific requirements established by each railway infrastructure manager for the use of machines which will be the subject of negotiation between the manufacturer and the machine keeper. This document does not deal with the following additional requirements: - working methods; - operation in severe working conditions requiring special measures (e.g. work in tunnels or in cuttings, extreme environmental conditions such as corrosive conditions, tropical conditions, contaminating conditions, strong magnetic fields); - operation subject to special rules (e.g. potentially explosive atmospheres); - hazards due to errors in software; - hazards occurring when used to handle suspended loads which may swing freely; - hazards due to wind pressure greater than normal e.g. pressures caused by the passing of trains at speed in excess of 190 km/h. 1.2 Validity of this European Standard This document applies to all machines that are ordered one year after the publication date of this European Standard.

 

This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.

 

This document establishes requirements, test procedures, assessment methods and acceptance criteria for operating rolling stock in open track. For pressure variations and slipstream effects beside the track, requirements and assessment methods are provided. For running resistance, assessment methods are addressed in this document. Load cases on infrastructure components due to train-induced pressure variations and slipstream effects are addressed in this document. For ballasted track test set-ups for ballast projection assessment are proposed. The requirements only apply to rolling stock of the heavy rail system with maximum train speeds above 160 km/h and not to other rail systems. The document is applicable to all rolling stock and infrastructure in open air with nominal track gauges of 1 435 mm to 1 668 mm inclusive.

 

 

 

This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry. This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption, or retrograde root-end filling (Type 2). The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy. This document does not specify requirements or test methods for sterility.

 

This document specifies the methodologies for calculation of braking performance for railway rolling stock. This document describes the general algorithms/formulae using instantaneous value inputs to perform calculations of brake equipment and braking performance, in terms of stopping/slowing distances, braking power and energy for all types of rolling stock, either as vehicles or units. The calculations can be performed at any stage of the assessment process (design, manufacture, testing, verification, investigation, etc.) of railway rolling stock. This document does not set out specific acceptance criteria (pass/fail). This document is not intended to be used as a design guide for the selection of brake subsystems and does not specify performance requirements. This document does not provide a method to calculate the extension of stopping distances when the level of demanded wheel/rail adhesion exceeds the available wheel/rail adhesion (wheel slide activity). This document contains examples of the calculation of braking forces for different brake equipment types and examples of the calculation of stopping distance for vehicles or units.

 

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 7.2.13 and 8.4.1 of the general standard. NOTE 1 See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance. ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function. ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use. ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

 

ISO 6876:2012 specifies requirements and test methods for root canal (endodontic) sealing materials which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use, i.e. a root filling placed from the coronal aspect of a tooth.

 

This document specifies the requirements for the function, design, performance, and testing of emergency push buttons that are installed in train’s driving’s cab. This document is applicable for emergency push button. This document is not applicable for emergency handle.

 

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 defines a process guideline and a methodology to support the introduction of new materials and processes to meet the minimum requirements in the railway sector for all rolling stock defined in EN 17343 and onboard equipment. This document is applicable to new materials and processes for all rolling stock and onboard equipment.