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This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield…

This document describes the methods for determining the activity in becquerel (Bq) of gamma‑ray emitting radionuclides in test samples by gamma-ray spectrometry. The measurements are carried out in a testing laboratory following proper sample preparation. The test samples can be solid, liquid or gaseous. Applications include: — routine surveillance of radioactivity released from nuclear…

1 Scope This document defines a RESTful protocol for the provision and delivery of resources that are related to user interface adaptation based on context of use. This document addresses requirements and recommendations for the following services: — user-context service; — task-context service; — equipment-context service; — environment-context service; — resource service; — resource-…

1 Scope 1.1 This Standard applies to wiring devices rated 60 A or less and intended for use in accordance with CSA C22.1, Canadian Electrical Code, Part I, as follows: a) Class 2 power supply outlets (USB) installed on i) faceplates of an outlet box; ii) a yoke similar to an outlet box mounted receptacle; or iii) mounted on a wall as a self-contained device; and b) combination…

1 Scope 1.1 This Standard applies to line pressure regulators (see Clause 3, Definitions), constructed entirely of new, unused parts and materials, hereinafter referred to as regulator(s), either individual or in combination with overpressure protection devices, hereinafter referred to as device(s), intended for application in gas piping systems between the service regulator, or LP-gas 2 psi (…

1 Scope 1.1 This Standard describes the requirements, including quality system requirements, for the O&M of an HCF. It sets out specific requirements for a) buildings and architectural systems; b) site elements related to the building and its functions, including on-site access routes; c) on-site utilities; d) the building's mechanical, electrical, and information technology, and…

1 Scope This document defines the Application Programming Interface (API) and Service Provider Interface (SPI) for standard interfaces within a biometric system that support the provision of that biometric system using components from multiple vendors. It provides interworking between such components through adherence to this and to other International Standards. For use in a system that does…

1 Scope This document specifies processes for the management and operation of data centres. The primary focus of this document is the operational processes necessary to deliver the expected level of resilience, availability, risk management, risk mitigation, capacity planning, security and energy efficiency. The secondary focus is on management processes to align the actual and future demands…

1 Scope This document supports the interest of system users in having consistent, complete, accurate, and usable information. It addresses both available approaches to standardization: a) process standards, which specify the way that information products are to be acquired and supplied; and b) information product standards, which specify the characteristics and functional requirements of the…

1 Scope 1.1 This Standard covers vacuum waste-collection systems intended to extract and transport water, condensate from refrigerators, sanitary waste, greywater, or grease and specifies requirements for materials, construction, performance testing, and markings. 1.2 In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order…