Toimialayhteisöt

 

This document specifies the cloud computing reference architecture (CCRA).

 

This document specifies a test method for the determination of gross beta activity concentration in non-saline waters. The method covers non-volatile radionuclides with maximum beta energies of approximately 0,3 MeV or higher. Measurement of low-energy beta emitters (e.g. 3H, 228Ra, 210Pb, 14C, 35S and 241Pu) and some gaseous or volatile radionuclides (e.g. radon and radioiodine) are not be included in the gross beta quantification using the test method described in this document. This test method is applicable to the analysis of raw and drinking waters with low amounts of total soluble salts in the water. Limit of detection depends on the performance characteristics (background count rate and counting efficiency) of the counter used. It is the laboratory’s responsibility to ensure the suitability of this method for the water samples tested. As this method requires sample preparation in laboratory facilities, it is not suited for rapid, in-the-field analysis.

 

ISO 14001 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability. ISO 14001 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties. Consistent with the organization's environmental policy, the intended outcomes of an environmental management system include: · enhancement of environmental performance; · fulfilment of compliance obligations; · achievement of environmental objectives. ISO 14001 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective. ISO 14001 does not state specific environmental performance criteria. ISO 14001 can be used in whole or in part to systematically improve environmental management. Claims of conformity to ISO 14001, however, are not acceptable unless all its requirements are incorporated into an organization's environmental management system and fulfilled without exclusion.   Note: This is a consolidated version, which means the amendment will be published as a new version. This approach was chosen to enhance readability and improve the overall user experience.

 

This document defines basic terms for district heating and cooling systems, including the components of sources, pipelines, substations, stations, and users. The Scope clause is a mandatory element of the text.For rules on the drafting of the Scope, refer to the ISO/IEC Directives, Part 2:2021, Clause 14.

 

This document specifies, principles and a process for the clinical evaluation of medical devices. This document specifies how to plan and perform clinical evaluation, including the collection, appraisal and analysis of data to assess the safety and, clinical performance or effectiveness, including clinical benefit(s) of medical devices, and to evaluate the acceptability of clinical risks when weighed against the clinical benefits achieved when the device under evaluation (DUE) is used as intended by the manufacturer. This includes the determination whether there is evidence for the assessment. This document also: — defines the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation on behalf of the manufacturer, — assists manufacturers, regulatory authorities and other stakeholders involved in the process or assessment of the clinical evaluation of medical devices and, — provides guidance on the scientific conduct of a clinical evaluation, thereby supporting the credibility of conclusions. This document does not apply to in vitro diagnostic medical devices. NOTE 1 National regulations can have additional or different requirements. NOTE 2 Some of the principles of this document can apply to actors other than manufacturers involved in clinical evidence generation.

 

This International Standard provides general guidance for the design of test rooms intended for the sensory analysis of products. It describes the requirements to set up a test room comprising a testing area, a preparation area, and an office, specifying those that are essential or those that are merely desirable. This International Standard is not specific for any product or test type. NOTE The test space can be similar for food and non-food products that are evaluated using sensory methods. However, the test rooms might need to be adapted for each specialized use. Modifications to the design are often needed for specific products and for specific types of testing. This is particularly true if the test rooms are to be used for the evaluation of non-food products. This standard can be applicable for quality control functions.

 

This document specifies the principal specifications of the thermoplastic water meter cabinets in terms of  the thickness of material, design drawing, dimensions and accessories incorporated into the construction of it for pipe sizes from 1/2” to 1 1/4” (from 12,7mm to 31,75 mm).

 

This document specifies a test method for the determination of the boiling water shrinkage of non-textured and textured multifilament yarns (made of polyester, polyamide, polypropylene, cellulose fibre, etc.). Only an automatic method is specified in this document. This document is applicable to manmade filament yarns and not applicable to partially oriented yarns.

 

 

This document specifies requirements and gives recommendations for the manufacture and processing of metallic materials for service in equipment used in oil and gas production in H2S-containing environments, where the failure can pose a risk to the functionality of the equipment, to the health and safety of the public and personnel or to the environment. It supplements, but does not replace, the materials specification requirements given in the appropriate design codes, standards, or regulations. This document addresses the metallurgical, manufacturing and quality assurance / control testing requirements, for carbon and low alloy steels, cast irons, corrosion-resistant alloys and other alloys selected in accordance with ISO 15156-2:202x, Annex A or Annex B. Materials selection is not addressed; material selection requirements, including permitted exclusions for specific categories of equipment, specific applications and specific environments are defined in ISO 15156-2. Qualification of materials, manufacturing processes and/or materials specifications that are not listed in this document, are also not addressed (see ISO 15156-3 for qualification and verification of alternative materials, material selection limits, manufacturing processes or materials specifications). Additive manufactured (AM) equipment and components are out of scope of this document.

 

This document specifies procedural instructions for qualification testing of thermal sprayers. It defines requirements, ranges of qualification, test conditions, acceptance requirements and certification for qualification testing of thermal spray performance. This document is applicable when the thermal sprayer’s qualification is required by this document, the purchaser, by inspection authorities or by other organizations. The thermal spraying processes referred to in this document include those spraying processes which are designated as manual or mechanized. The test for mechanised application includes the use of automatically controlled thermal spraying, e.g. robotics, scan units.

 

 

This part of ISO 17536 specifies general conditions, defines terms and establishes the basic principles for blowby oil aerosol separator performance tests by laboratory or engine and gravimetric or fractional test method. Conformance of a device to legislation is outside of the scope of this standard and the appropriate regulations must be consulted.

 

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment. Me equipment that measures a body temperature is inside the scope of this document. ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601-2-59[4]. 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+A1:2012, 7.2.13 and 8.4.1. NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.

 

ISO 14918:2018 specifies procedural instructions for qualification testing of thermal sprayers. It defines requirements, ranges of qualification, test conditions, acceptance requirements and certification for qualification testing of thermal spray performance. ISO 14918:2018 is applicable when the thermal sprayer's qualification is required by this document, the purchaser, by inspection authorities or by other organizations. The thermal spraying processes referred to in this document include those spraying processes which are designated as manual or mechanized. The test for mechanised application includes the use of automatically controlled thermal spraying, e.g. robotics, scan units.

 

This Part of this European Standard specifies the requirements for fabrication and installation of piping systems, including supports, designed in accordance with EN 13480-3:2017.

 

ISO 23146:2012 specifies a method for the determination of the fracture toughness of advanced technical ceramics. The procedure makes use of single-edge V-notched bars, which are loaded in four-point bending until failure. It is applicable to monolithic ceramics with a grain size or major microstructural feature size larger than about 1 µm. The use of ISO 23146:2012 for yttria tetragonal zirconia polycrystal material (Y-TZP) is not recommended. The method might also be unsuitable for some other very tough or soft ceramics in which a sharp crack does not form at the root of the V-notch.

 

This document specifies terminology, principles and a process for the clinical evaluation of medical devices. The process described in this document aims to assist manufacturers of medical devices to estimate the clinical risks associated with a medical device and evaluate the acceptability of those risks in the light of the clinical benefits achieved when the device is used as intended. The requirements of this document are applicable throughout the life cycle of a medical device. The process described in this document applies to the assessment of risks and benefits from clinical data obtained from the use of medical devices in humans. This document specifies general requirements intended to — verify the safety of medical devices when used in accordance with their instructions for use; — verify that the clinical performance or effectiveness of a medical device meet the claims of the manufacturer in relation to its intended use; — verify that there is sufficient clinical evidence to demonstrate the achievement of a positive benefit/risk balance when a medical device is used in the intended patient population in accordance with its intended use; — ensure the scientific conduct of a clinical evaluation and the credibility of conclusions drawn on the safety and performance of a medical device; — define the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation; and — assist manufacturers, clinicians, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Note 1 This standard can be used for regulatory purposes. Note 2 This document does not apply to in vitro diagnostic medical devices. However, there may be situations, dependent on the device and national or regional requirements, where sections and/or requirements of this document might be applicable.

 

This document describes the procedures to prepare plutonium sources and  to measure the activity ratio of 238Pu to (239Pu + 240Pu) by alpha spectrometry. The alpha spectrometry method is used for the determination of isotopic abundance of 238Pu in combination with isotope amount ratios determined by mass spectrometry and eliminates the possible isobaric interferences of 238U in the latter method. It is applied to the analysis of purified solutions of plutonium in 2 mol/l to 4 mol/l nitric acid containing 50 µg to 200 µg of plutonium per millilitre, as may result from the chemical treatment and purification preceding plutonium isotopic analysis by mass spectrometry. This document is applied to plutonium solutions free from 241Am and those containing less than 10 % of other non-volatile impurities relative to the plutonium content. Otherwise purification should be carried out in accordance with ISO 8299[1]. The methods provided in this document are intended for use in conjunction or in parallel with mass spectrometry for the isotopic analysis of plutonium in spent-fuel solutions or nuclear-grade plutonium products.