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This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. NOTE 1 Conserving equipment can also be used in professional health care facilities. This document is also applicable to conserving equipment that is incorporated with other equipment. EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4]. This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). 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 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

 

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft. NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities. This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function. EXAMPLE 2 An oxygen concentrator used with a flowmeter stand. EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]. EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. 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 7.2.13 and 8.4.1 of the general standard. NOTE 3 See also 4.2 of the general standard.

 

This document provides the method to characterize and classify the quality of track geometry based on parameters defined in EN 13848-1:2019. This document also specifies different track geometry classes. This document does not: - apply to lines with a nominal gauge less than 1 435 mm; - specify requirements for Urban Rail Systems.

 

ISO 11609:2017 specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and packaging of dentifrices. ISO 11609:2017 applies to dentifrices, including toothpastes, destined to be used by the consumers on a daily basis with a toothbrush to promote oral hygiene. Specific qualitative and quantitative requirements for freedom from biological and toxicological hazards are not included in this document. These are covered in ISO 7405[1] and ISO 10993-1[2].

 

 

 

This document specifies safety and performance requirements of domestic ceramic and glass ceramic cookware for use on top of a stove, cooker or hob. This document envisages that oven top applications for ceramic utensils involve all or specific parts of the cooking operation, for example, the browning of meat, where the remainder of the cooking can be completed in an oven or on top of the stove. NOTE Requirements for suitability for use with induction hobs are in the process of being compiled.

 

This document specifies the dimensional requirements of high-pressure liquid fuel pipe end-connections for gasoline (spark ignition) engine fuel injection equipment. It is applicable to externally threaded end-connections having a 60° concave cone (see Figure 1), as well as to the pipe end assemblies of high-pressure fuel injection pipes with outside diameters of up to and including 10 mm (see Table 1)

 

This document specifies the functions and quality evaluation of specimen collection booth as part of pandemic response management by respiratory diseases.

 

This document is applicable to biology, chemistry and physics laboratories where research, preparative, analytical, process activities take place and which can involve work with hazardous substances, including higher education (college and university teaching and post-graduate research). This document does not cover the requirements of schools, i.e. pre college/pre-university (refer to EN 13150), or highly specialist laboratories which need very specific, bespoke solutions to enable them to function. This document specifies requirements for installation and design of laboratory benches, associated storage units, and for the provision and connection of services integral or delivered to the laboratory benches. This document gives guidelines for all parties involved in the planning, design, manufacture, installation, testing of a new laboratory or in the refurbishment of an existing laboratory. For safety storage cabinets for flammable liquids EN 14470-1 and for pressurized gas cylinders EN 14470-2 applies.

 

 

This document specifies a method for the determination of the moisture content in a test portion of the laboratory sample by drying the test portion in an oven. This method can be used for routine production control on site, e.g. if a high precision of the determination of moisture content is not required. It is applicable to all solid recovered fuels. If solid recovered fuels contain large amounts of oil-fractions a lower temperature is recommended (e. g. 50 °C ± 10°C) and a longer drying time until constant mass is achieved. As an alternative the Karl-Fischer-Titration-Method according to ISO 760 is advisable.

 

This Document specifies a method for the determination of total moisture content of solid recovered fuels (SRF) by drying a sample in an oven. This method is suitable for use for routine production control on site, e.g. if a high precision of the determination of moisture content is not required. It is applicable to all solid recovered materials including solid recovered fuels. NOTE 1 The total moisture content of solid recovered materials including solid recovered fuels is not an absolute value and therefore standardised conditions for its determination are indispensable to enable comparative determinations. NOTE 2 The term moisture content when used with SRF can be misleading since these materials often contain varying amounts of volatile compounds (extractives) which can evaporate if determining moisture content by oven drying.

 

This document defines a method of determining bulk density of solid recovered fuels by the use of a standard measuring container. This method is applicable to all SRFs with a nominal top size of particle less than 1/3 of the container diameter specified in this document.

 

 

 

This document specifies common requirements for transportable liquid oxygen systems and specific requirements for base units. Base units are used as a store for liquid oxygen for recharging portable units. They may also, if fitted with a flow outlet and flow selector, be used as a source for the supply of oxygen direct to the patient.

 

This document specifies requirements for portable units which are part of a transportable liquid oxygen system. These are used as a supply source for oxygen therapy in home-care and in health-care facilities. Portable units are intended to be carried by patients whilst moving around and during their off-site activities and can be refilled from a base unit through a transfilling connector. Portable units are used without professional supervision.

 

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, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA. This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and 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.

 

This international standard defines a method of determining bulk density of solid recovered fuels by the use of a standard measuring container.