Yhteinen Toimialaliitto

 

This document specifies requirements and provides recommendations for the pre-examination phase of cell free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, cerebrospinal fluid (CSF), pleural effusions and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen cleaning and isolation of cfDNA. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this document. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving circulating cell free DNA (ccfDNA) from blood. These are not described in this document, but are covered in ISO 20186-3. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

 

This document is a product specification, giving performance requirements for emergency safety body showers connected to the water supply. It is applicable to plumbed-in body showers only, located in laboratory facilities. Requirements are given in respect of the performance, installation, adjustment and marking of the showers as well as installation, operation and maintenance instructions to be given by the manufacturer. NOTE Attention is drawn to national regulations which might apply in respect of the installation and use of emergency safety showers.

 

This document is a product specification, giving performance requirements for emergency safety eye-wash units connected to the water supply. It is applicable to plumbed-in eye-wash units only. Requirements are given in respect of the performance, installation, adjustment and marking of the eye-wash units, as well as installation, operation and maintenance instructions to be given by the manufacturer. NOTE Attention is drawn to national regulations which can apply in respect of the installation and use of eye-wash units.

 

This document specifies requirements and associated test methods for assistive products for toileting, bathing and showering (from herein referred as ‘assistive product’ within the standard) and which are considered to be medical devices, intended by the manufacturer to alleviate or compensate for disability. The standard specifies safety, functional and ergonomic requirements for both persons with disability and assistants that apply during normal use and foreseeable misuse and failure. This document specifies requirements and test methods for assistive products within the following divisions of EN ISO 9999:2022. There are no specific requirements and test methods for products marked with *. Only the relevant general requirements apply when these products are considered to be medical devices. This document does not apply for:

 

 

This document specifies requirements and associated test methods for assistive products for toileting, bathing and showering (from herein referred as ‘assistive product’ within the document) and which are considered to be medical devices, intended by the manufacturer to alleviate or compensate for disability. NOTE Assistive products are considered to be medical devices in some jurisdictions but not in others. The work environment and safety aspects for assistants are also included. It specifies safety and performance requirements that apply during normal use and foreseeable misuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and specifies limits on the forces needed for some operations. This document specifies requirements and test methods for assistive products within the following divisions of ISO 9999: 09 12 03 Commode chairs; 09 12 06 Toilets; 09 12 09 Toilet seats; 09 12 10 Toilet splash guards; 09 12 12 Raised toilet seats mounted on frame; 09 12 15 Toilet seats inserts; 09 12 18 Raised toilet seats fixed to toilet; 09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down; 09 12 24 Toilet arm supports and toilet back supports mounted on toilet; 09 12 25 Toilet arm supports and toilet back supports, free standing; 09 12 36 Douches and air dryers for attachment to a toilet; 09 33 04 Bath boards 09 33 05 Bath seats 09 33 07 Shower chairs with and without wheels 09 33 08 Back supports for bath or shower 09 33 12 Bathing stretchers, shower tables and diaper-changing tables; NOTE: Mainstream diaper-changing tables for babies/toddlers are excluded. They are covered by EN 12221-1 and EN 12221-2. 09 33 15 Wash basins NOTE: General requirements for wash basins are covered by EN 14688. 09 33 18 Bidets 09 33 21 Bathtubs 09 33 36 Assistive products for drying oneself 18 15 06 Height adjustable plinths and brackets; 18 18 03 Handrails and support rails; 18 18 06 Fixed grab bars and handgrips; 18 18 10 Removable grab rails and handgrips; 18 18 11 Hinged rails and arm supports; This document does not encompass requirements regarding: — safe mounting in building structures; — fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation to excretion-disposal and -wrapping systems; — 12 36 15 bathtub hoists that are covered by ISO 10535; — 09 33 21 Bathtubs — stability and friction issues in relation to slippery surfaces due to soap; — products that have been customised or custom-made for an individual user. NOTE: this list is based on ISO 9999:2016, however in the revision process, this will be updated to corresponding codes of ISO 9999:2022

 

This document specifies the conditions for the visual inspection of domestic articles made from ceramic, glass, glass ceramic, decorated glass, vitreous enamel, coatings, rubber, silicones, metal, and plastics after testing its dishwashing resistance according to the procedures described in the relevant parts of the EN 12875 series.

 

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 specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that may include: This document includes requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer. The following devices are not included within the scope of this document:

 

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 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 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 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 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 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.