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ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices.

This document specifies the requirements for steel products used for industrial piping and supports. For some metallic materials other than steel, such as spheroidal graphite cast iron, aluminium, nickel, copper, titanium, requirements are or will be formulated in separate parts of this document. For metallic materials which are not covered by a harmonized material standard and are not likely to be in near future, specific rules are given in this part or the above cited parts of this document.

This document specifies the requirements for steel products used for unfired pressure vessels. For some metallic materials other than steel, such as spheroidal graphite cast iron, aluminium, nickel, copper, titanium, requirements are or will be formulated in separate parts of this document. For metallic materials which are not covered by a harmonized material standard and are not likely to be in near future, specific rules are given in this part or the above cited parts of this document.

This document specifies the characteristics of tab washers, in heat resisting steel, passivated, for maximum operating temperature 650 °C, for aerospace applications. Their use under hexagon head bolts is conditional upon the user accepting the possibility of some interference.

This calculation module applies to instantaneous domestic hot water heat recovery using a counter-flow heat exchanger between the drain water and the incoming domestic cold water. This module calculates the recovered heat, to be taken into account in the overall calculation procedure of the energy performance of the building. The scope of this document is to standardize the: - required inputs; - calculation methods; - required outputs; of the instantaneous heat recovery from domestic hot water drains. This document provides a calculation method for one calculation interval. This calculation is intended to be connected to the whole building calculation model and takes into account the external conditions and system controls that may influence the instantaneous heat recovery from domestic hot water drains. This document does not apply to storage heat recovery or the use of drain water as a source for heat pumps. This document does not apply to sizing or inspection of domestic hot water heat recovery devices. Table 1 shows the relative position of this document within the set of EPB standards in the context of the modular structure as set out in EN ISO 52000-1. NOTE 1 The same Table is found in CEN ISO/TR 52000-2, with, for each module, the numbers of the relevant EPB standards and accompanying technical reports that are published or in preparation. NOTE 2 The modules represent EPB standards, although one EPB standard might cover more than one module and one module might be covered by more than one EPB standard, for instance a simplified and a detailed method respectively. See also Clause 2 and Table A.1 and Table B.1.

This is a New Work ballot to re-activate a cancelled project. This document specifies principles, requirements, recommendations and other provisions for preparing and presenting instructions for the assembly of self-assembly products intended for a non-skilled target audience assembling a product without help from a trainer or supervisor. This document is applicable to instructions for: — supporting the assembly of a product that is supplied as a kit of components designed to be assembled into a specific item, which can have alternative assembly configurations (often described as “flatpack products”); — installing products supplied with components (e.g. screws) intended for attachment to existing products (e.g. a vehicle) or fixtures (e.g. a wall); — erecting or configuring products that incorporate structural elements requiring folding, locking or tensioning (e.g. child pushchairs, camping equipment); — supporting the assembly of a specific product intended to be assembled by a non-skilled assembler for their own use or for use by another individual (e.g. assembly of a toy by a parent for subsequent use by a child). This document does not apply to: — components or constructional material supplied in combinations and numbers specified by the customer; — multiple identical kits supplied in batches for professional assembly and commercial sale as an assembled product; — products intended for professional assembly only by someone skilled or trained in assembling such products or by a skilled person whose relevant technical education, training or experience enables them to perceive risks and avoid hazards in the assembly and use of a category of products (e.g. electrician, vehicle mechanic). This document is applicable to all parties involved in the preparation of instructions for self-assembly, including: — product suppliers; — hardware and software product and information designers; — technical communicators and technical illustrators; — testers and evaluators; — managers; — safety authorities. This document is supplementary to IEC/IEEE 82079-1, which specifies provisions applicable to the preparation of all information for use of products – including self-assembly and all other phases (such as operation, maintenance and disposal).

This standard describes the requirements to be satisfied by domain-specific reference architectures that address entities of interest such as software, systems, enterprises, missions, systems of systems, families of systems, products (goods or services), product lines, service lines, technologies and business domains. The proposed standard will be universally applicable to — organizations seeking sustained success through the implementation of architecture practices, — organizations and interested parties seeking to improve communication through a common understanding of the vocabulary and concepts used in reference architectures, — organizations performing conformity assessments against the requirements of reference- architecture-related standards and specifications, — organizations that serve as certification authorities that will benefit from the use of reference architectures, — organizations that need to mandate use of reference architectures, — providers of reference architectures, guidelines, training, education, evaluation or recommendations in architecture practice, — developers of reference-architecture standards, reference models, and related tools/technologies, — users of reference architectures. The application areas of this standard include, but are not limited to, the following: artificial intelligence (AI), machine learning (ML), Internet of Things (IoT), cloud computing, big data, smart cities, smart manufacturing, cybersecurity, digital twin, telecommunications, aerospace, defense, banking, finance, insurance, energy, automotive, logistics, hospitality, healthcare, supply chain, transportation, manufacturing, agriculture, production, and infrastructure. The proposed deliverable is part of the ISO 42000 architecture standards (e.g., 42010, 42020, 42030).

The requirements in this document govern the application of a set of explicit algebraic formulae for the calculation of specific characteristics of radiation heat flux from an open pool fire.

This document is an implementation of the general requirements provided in ISO 16730‑1 for the case of fire dynamics calculations involving a set of explicit algebraic formulae.

This document is arranged in the form of a template, where specific information relevant to the algebraic formulae is provided to satisfy the following types of general requirements:

a) description of physical phenomena addressed by the calculation method;

b) documentation of the calculation procedure and its scientific basis;

c) limitations of the calculation method;

d) input parameters for the calculation method; and

e) domain of applicability of the calculation method.

Examples of sets of algebraic formulae meeting the requirements of this document are provided in Annexes A and B. Annex A contains a set of algebraic formulae for radiation heat fluxes from a circular or near-circular open pool fire. Annex B contains formulae for configuration factors of a flame to a target.

This document specifies test methods for the determination of the technical characteristics of underlays under laminate floor coverings. It includes minimum performance requirements for the underlay-flooring system to give satisfactory service and to encourage the consumer to make an informed choice. It also specifies requirements for marking and packaging. Underlays pre-attached to the laminate flooring coverings are not covered by this document. Underlays for laminate floor coverings intended for use in electrostatically sensitive areas such as computer rooms, etc., are not covered by this document.

This document specifies engineering requirements for cybersecurity risk assessment regarding concept, product development, production, operation, maintenance and decommissioning of electrical and electronic (E/E) systems in Agricultural Machinery & Tractors, including their components and interfaces. A framework is defined that includes requirements for cybersecurity processes and a common language for communicating and managing cybersecurity risk.

This document sets the basic principles for determination of groundwater remediation target value for uranium in-situ leaching, the environmental investigation requirements for uranium in-situ leaching, groundwater remediation technology and economic-benefit analysis, and the procedure for determination of groundwater remediation target value This document is applicable to control and remediation of groundwater impact of uranium in-situ leaching.

This document specifies requirements to be met by a management system for records (MSR) in order to support an organization in the achievement of its mandate, mission, strategy and goals. It addresses the development and implementation of a records policy and objectives and gives information on measuring and monitoring performance.

An MSR can be established by an organization or across organizations that share business activities. Throughout this document, the term "organization" is not limited to one organization but also includes other organizational structures.

This document is applicable to any organization that wishes to:

— establish, implement, maintain and improve an MSR to support its business;

— ensure itself of conformity with its stated records policy;

— demonstrate conformity with this document by

undertaking a self-assessment and self-declaration, or

seeking confirmation of its self-declaration by a party external to the organization, or

seeking certification of its MSR by an external party.

This document specifies requirements for the design and installation of early suppression fast response (ESFR) and control mode specific application (CMSA) sprinklers in automatic sprinkler systems, in accordance with this standard and additionally the EN 12845 series of standards. This document does not cover all legislative requirements. NOTE In certain countries, specific national regulations can apply. Attention is drawn to the applicability or non-applicability for this document as specified by national responsible authorities.

ISO 8589 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. ISO 8589 is not specific for any product or test type. Although many of the general principles are similar, ISO 8589 does not address test facilities for the specialized examination of products in inspection or in-plant quality-control applications.

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 a chamber method with three options of test chambers for the determination of the formaldehyde emission from wood-based panels in terms of the steady-state concentration in a climate chamber under defined conditions, which relate to typical conditions in real-life. This chamber method can also be applied to the estimation of formaldehyde concentrations under various conditions in practice, by the use of mathematical models. This document can also be used for the testing of formaldehyde emissions of products other than wood-based panels.

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.

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.

The method is applicable to types of steel with niobium contents between 0,005 % (m/m) and 1,3 % (m/m). Specifies principle, reagents, apparatus, sampling, procedure, expression of results and test report. Annex A includes additional information on the international co-operative tests. Annex B gives a graphical representation of precision data.

This document provides trustworthiness requirements and guidance for data space participants in support of trusted data transactions. Specifically, it defines a set of foundational principles for trusted data transactions, and establishes general requirements and guidance that apply to all phases of a trusted data transaction, and specific requirements for each phase of a trusted data transaction. This document applies to all types of organizations participating in data spaces, regardless of their type or size.