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ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations. The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time. ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.

This document provides specifications for the production of unreinforced, reinforced and prestressed precast concrete products protected from adverse weather conditions during production, and made of compact light-, normal- and heavyweight concrete according to EN 206 with no appreciable amount of entrapped air other than entrained air. Concrete containing fibres for other than mechanical properties (steel, polymer or other fibres) is also covered. This document also covers clay, EPS, and lightweight formwork blocks for beam-and-blocks floor systems. It does not cover precast reinforced components of lightweight aggregate concrete with open structure nor glassfibre reinforced concrete. It can also be used to specify products for which there is no standard.

This document specifies the measurement method for the determination of total activity concentration of uranium isotopes in non-saline waters by extraction and liquid scintillation counting. This method covers the measurement of soluble uranium isotopes in water in activity concentrations between approximately 2·10−3 Bq/kg and 10 Bq/kg when analysing a 1 l test sample volume with a 60 000 s counting time with a typical alpha LSC instrument. The ratio 234U/238U can also be determined. This method has not been tested for the measurement of other uranium isotopes.

This Part of this European Standard specifies the requirements for inspection and testing of industrial piping as defined in EN 13480-1:2017 to be performed on individual spools or piping systems, including supports, designed in accordance with EN 13480-3:2017 and EN 13480-6:2017 (if applicable), and fabricated and installed in accordance with EN 13480-4:2017.

This document specifies a qualitative procedure to qualifying leather animal species of (fibrous) protein from leather by MALDI-TOF mass spectrometer (MS). The composition of other fibres can be measured by methods described in the ISO 1833 series. Both results are then combined to determine the whole composition of fibres (see Annex C as an example of mixtures of (fibrous) protein from leather and polyester). The method is based on a preliminary identification, by light microscopy, of all fibres in a blend on the basis of their morphology, according to ISO/TR 11827.

This standards shall provide specifications applicable to vulnerability handling processes, covering all relevant product categories, to be put in place by manufacturers of the products with digital elements. Those processes shall at least allow to: (a) identify and document vulnerabilities and components contained in the product, including by drawing up a software bill of materials in a commonly used and machinereadable format covering at the very least the top-level dependencies of the product; (b) in relation to the risks posed to the products with digital elements, address and remediate vulnerabilities without delay, including by providing security updates; where technically feasible, new security updates shall be provided separately from functionality updates; (c) apply effective and regular tests and reviews of the security of the product with digital elements; (d) once a security update has been made available, share and publicly disclose information about fixed vulnerabilities, including a description of the vulnerabilities, information allowing users to identify the product with digital elements affected, the impacts of the vulnerabilities, their severity and clear and accessible information helping users to remediate the vulnerabilities; in duly justified cases, where manufacturers consider the security risks of publication to outweigh the security benefits, they may delay making public information regarding a fixed vulnerability until after users have been given the possibility to apply the relevant patch; (e) put in place and enforce a policy on coordinated vulnerability disclosure; (f) take measures to facilitate the sharing of information about potential vulnerabilities in their product with digital elements as well as in third party components contained in that product, including by providing a standardised contact address for the reporting of the vulnerabilities discovered in the product with digital elements; (g) provide for mechanisms to securely distribute updates for products with digital elements to ensure that vulnerabilities are fixed or mitigated in a timely manner, and, where applicable for security updates, in an automatic manner; (h) ensure that, where security updates are available to address identified security issues, they are disseminated without delay and, unless otherwise agreed between manufacturer and business user in relation to a tailor-made product with digital elements, free of charge, accompanied by advisory messages providing users with the relevant information, including on potential action to be taken.

ISO 28706-2:2017 specifies a test method for the determination of the resistance of flat surfaces of vitreous and porcelain enamels to boiling acids, boiling neutral liquids, alkaline liquids and/or their vapours. This method allows the determination of the resistance of vitreous and porcelain enamels to the liquid and vapour phases of the corrosive medium simultaneously.

This document describes a test method for the determination of the resistance of vitreous and porcelain enamelled articles to attack by alkaline liquids at temperatures between 25 °C and 95 °C. The apparatus used is a cylindrical vessel with a volume-surface ratio 20:1 cm in which only one enamelled specimen is tested.

NOTE 1 The test method was initially set up for determination of the resistance of vitreous and porcelain enamels to a hot sodium hydroxide solution. Within the scope of this part of ISO 28706, the resistance of other alkaline liquids can be tested.

NOTE 2 This part of ISO 28706, which uses a cylindrical vessel, is generally used for tests carried out on vitreous and porcelain enamel coatings for the chemical industry

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.