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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.
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).
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 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 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.
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.
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.
ISO 28706-4:2016 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 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 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 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 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 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.
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.
ISO/IEC 22123-1:2023 defines terms used in the field of cloud computing.
This document specifies concepts used in the field of cloud computing. These concepts expand upon the cloud computing vocabulary defined in ISO/IEC 22123-1 and provide a foundation for other documents that are associated with cloud computing.
This document specifies the cloud computing reference architecture (CCRA).
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 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 a procedure for the determination of the dimensional changes and distortion out of plane likely to take place when textile floor coverings and tiles are subjected to varied water and heat conditions.
The method is applicable to all textile floor coverings and textile floor coverings in tile form.