Normy

Obsah

ČSN EN ISO 10319 This document specifies an index test method for the determination of the tensile properties of geosynthetics (polymeric, glass and metallic), using a wide-width strip. This document is applicable to most geosynthetics, including woven geotextiles, nonwoven geotextiles, geocomposites, knitted geotextiles, geonets, geomats and metallic products. It is also applicable to geogrids and similar open-structure geotextiles, but specimen dimensions will possibly need to be altered. It is not applicable to polymeric or bituminous geosynthetic barriers, but it is applicable to clay geosynthetic barriers. This document specifies a tensile test method that covers the measurement of tensile force, elongation characteristics and includes procedures for the calculation of secant stiffness, maximum load per unit width and strain at maximum force. Singular points on the tensile force-extension curve are also indicated. Procedures for measuring the tensile properties of both conditioned and wet specimens are included in this document.

Obsah

ČSN EN ISO 13997 This document specifies a tomodynamometer cut test method and related calculations, for use on materials and assemblies designed for protective clothing, including gloves. The test determines resistance to cutting by sharp edges, such as knives, sheet metal parts, swarf, glass, bladed tools and castings. When this document is cited as a test method in a material or product requirement standard, that standard contains the necessary information to permit the application of this document to the particular product. This test does not provide data on the resistance to penetration by pointed objects such as needles and thorns, or the point of sharp-edged blades. The test described in this document is not considered suitable for testing materials made from chain mail and metal plates. The text of this document does not include provisions for the safeguard of the operator.

Obsah

ČSN EN ISO 11334-4 This document specifies requirements and test methods of walking sticks with three or more legs used as assistive products for walking, manipulated by one arm, without accessories, unless specified in the particular test procedure. This document also gives requirements related to safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling. The requirements and tests are based on every-day use of walking sticks with three or more legs as assistive products for walking for a maximum user mass as specified by the manufacturer. This document is for walking sticks with three or more legs specified for a user mass of no less than 35 kg. This document is not applicable to walking sticks with three or more legs with underarm or forearm support or with moving parts such as a universal joint.

Obsah

ČSN EN ISO 18562-3 This document specifies tests for the emissions of volatile organic substances from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests. NOTE - Gaseous emission of volatile organic substances includes emissions of volatile organic compounds, semi-volatile organic compounds and very volatile organic compounds. This document addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories, which is then conducted to the patient. This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE - Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series. This document is intended to be read in conjunction with ISO 18562-1.

Obsah

ČSN EN ISO 18562-4 This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024. This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas to the patient. This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE - Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device. This document does not address contact with drugs or anaesthetic agents. If a medical device or accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient.

Obsah

ČSN EN 17984-1 This document specifies the terms and definitions that apply to: - different types of assistance dogs; - the beneficiary and client services; - health and disabilities; - assistance dog service providers; - assistance dog training staff and related professionals; - the socialization and training processes; - conformity assessment, identification and registration; - accessibility.

Obsah

ČSN EN ISO 18562-2 NOTE - There is guidance or rationale for this Clause contained in Clause A.2. This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm diameter. This document does not address particles larger than 10 µm diameter. These particles are deposited in the nasal cavity. Additional information can be needed for medical devices or accessories that bypass the nose. This is outside the scope of this document but can be required by some authorities having jurisdiction. This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry. This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient. This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing. This document does not address biological evaluation of the particles that are deliberately released by a nebulizer (i.e. the therapeutic agent). This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series. Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE - Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 (all parts).

Obsah

ČSN ETSI EN 301 489-52 V1.3.1 The present document specifies the applicable test conditions, performance assessment, and performance criteria for Cellular Communication User Equipment (UE), including Customer Premise Equipment (CPE), Set Top Box (STB) containing cellular communication technologies, and the associated ancillary equipment in respect of ElectroMagnetic Compatibility (EMC) for equipment utilizing the technologies in table 1. Technical specifications related to the antenna port of radio equipment, radiated emissions from the enclosure port of radio equipment, and combinations of radio and associated ancillary equipment are not included in the present document. Such technical specifications are normally found in the relevant product standards for the effective use of the radio spectrum. NOTE 1 - The relationship between the present document and the essential requirements of article 3.1(b) of Directive 2014/53/EU [i.2] is given in annex A. NOTE 2 - The present document does not cover the radio base stations as specified in ETSI EN 301 489-50 [i.13]. Technical specifications related to conducted emission EMC requirements below 9 kHz on the AC mains port of radio equipment are not included in the present document. NOTE 3 - Such technical specifications are normally found in the relevant product family standards for AC mains powered equipment (e.g. EN 61000-3-2 [i.14] and EN 61000-3-3 [i.15]).

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ČSN EN ISO 20957-2 This document specifies safety requirements for stationary strength training equipment, in addition to the general safety requirements of ISO 20957-1:2013. This document is applicable to stationary strength training equipment with stacked weight resistance or alternative means of resistance, such as elastic cords, hydraulic, pneumatic, electrical, magnetic, springs and externally loaded weights (hereinafter referred to as stationary training equipment) with the classes H, S and I according to ISO 20957-1:2013.

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ČSN EN ISO 7499 This document specifies how to uniquely identify the integral features of a part by an integral feature indicator with a unique alpha-numerical label and how indication in technical product documentation (TPD) is done, where needed to improve human readability. The proportions and dimensions of graphical symbols for a simplified indication of repeated features are also specified.

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ČSN EN 17948 This document specifies the main content of maintenance management and the main activities for which maintenance management is responsible. This document is applicable to maintenance managers and as-set managers in the industry sector and for infrastructure and buildings in order to achieve the success factors of the organization.

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ČSN EN ISO 5114-1 Tento dokument poskytuje pokyn pro stanovení nejistot měření hladin akustického výkonu určených v souladu s ISO 3741, ISO 3743-1, ISO 3743-2, ISO 3744, ISO 3745, ISO 3746, ISO 3747 nebo v souladu se zkušebním předpisem pro hluk, který je založen na některé z těchto norem pro měření.