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This document provides structural and governance requirements of a register and its management. Register management processes include the establishment, management, operation and publication of a register. Specifically, these processes and their procedures facilitate: The following considerations are out of scope of this document:

 

ISO 13802:2015 specifies frequency and methods for the verification of pendulum impact-testing machines used for the Charpy impact test, Izod impact test, and tensile impact test described in ISO 179-1, ISO 180, and ISO 8256, respectively. Verification of instrumented impact machines is covered insofar as the geometrical and physical properties of instrumented machines are identical to non instrumented machines. The force/work verification of instrumented machines is not covered in this International Standard.

 

This document specifies requirements for and gives recommendations on the design, installation, alteration, testing, maintenance and operation of installations inside buildings conveying water intended for human consumption (hereafter referred to as potable water installations) within buildings and, for certain purposes, pipework outside buildings but within the premises (see Figure 1). It covers the system of pipelines, fittings and connected appliances installed for supplying potable water from the delivery point to the point of use.

 

This document specifies requirements for and gives recommendations on the design of potable water installations according to EN 806-1.

 

ISO 19135-1:2015 specifies procedures to be followed in establishing, maintaining, and publishing registers of unique, unambiguous, and permanent identifiers and meanings that are assigned to items of geographic information. In order to accomplish this purpose, ISO 19135-1:2015 specifies elements that are necessary to manage the registration of these items.

 

This document covers the design of PE and PP flexible packaging with respect to compatibility of the design with the collecting, sorting, and recycling processes. Packaging constituents and packaging components made of other materials than PE and PP are also covered by this document as they need to be evaluated on compatibility with polymer recycling.

 

This document covers the design of PS and XPS rigid packaging with respect to compatibility of the design with the collecting, sorting, and recycling processes. Packaging constituents and packaging components made of other materials than PS are also covered by this document as they need to be evaluated on compatibility with polymer recycling.

 

This document covers the design of EPS rigid packaging with respect to compatibility of the design with the collecting, sorting, and recycling processes. Packaging constituents and packaging components made of other materials than PS are also covered by this document as they need to be evaluated on compatibility with polymer recycling.

 

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.

 

This document is an input for a standard on the recyclability evaluation process of plastic packaging with respect to compatibility of the design with the collecting and sorting processes for the plastic used. This document covers any household plastic packaging where the main body is made of PET, PE, PP or PS material.

 

This document covers the design of PET rigid packaging (except bottles) with respect to compatibility of the design with the collecting, sorting, and recycling processes. Packaging constituents and packaging components made of other materials than PET are also covered by this standard as they need to be evaluated on compatibility with polymer recycling.

 

This document covers the design of PE and PP rigid packaging with respect to compatibility of the design with the collecting, sorting, and recycling processes. Packaging constituents and packaging components made of other materials than PE and PP are also covered by this standard as they need to be evaluated on compatibility with polymer recycling.

 

This document covers the design of PET bottles with respect to compatibility of the design with the collecting, sorting, and recycling processes. Packaging constituents and packaging components made of other materials than PET are also covered by this standard as they need to be evaluated on compatibility with polymer recycling.

 

This document provides a process that manages the identification of the level of compatibility of plastic packaging features with collection, sorting and recycling, describing the level of compatibility as fully, limited, and not recyclable. This standard covers any plastic packaging where the main body is made of plastic material. It targets to harmonize the design for recycling standard approach for each resin.

 

This document covers the design of PET pots and trays with respect to compatibility of the design with recycling processes. Packaging constituents and packaging components made of other materials than PET are also covered by this document as they need to be evaluated on compatibility with polymer recycling.

 

This document provides requirements for the evaluation process for PET Bottles with respect to compatibility of the design with recycling processes. Packaging components and ancillary elements made of other materials than PET are also covered by this document as they need to be evaluated for compatibility with the recycling processes.

 

This document covers recyclability evaluation process guidance for PS and XPS packaging with respect to compatibility of the design with recycling processes for the polymers used.

 

This document covers the design of EPS packaging with respect to compatibility of the design with recycling processes. Packaging constituents and packaging components made of other materials than EPS are also covered by this document as they need to be evaluated on compatibility with polymer recycling.