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This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the…

This part of ISO 15027 specifies performance and safety requirements for abandonment suits in emergency situations in work and leisure activities to protect the body of a user against the effects of cold water immersion, such as cold shock and hypothermia, including head, hand and feet protection. 1DV D2 Modification by revising the first paragraph of clause 1 by replacing the text with: This…

1.1 These requirements cover submetering equipment and open and enclosed type current sensors intended for factory or field installation within the wiring space of enclosures for switches or overcurrent devices. Installation is in accordance with the National Electrical Code, ANSI/NFPA 70 and the Canadian Electrical Code (CE Code), CSA C22.1. These requirements also cover "Service…

IEC 60601-1-9:2007+A1:2013+A2:2020 The objective of this collateral standard is to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle: - product specification; - design; - manufacturing; - sales, logistics, installation; - use; - end of life management. This means protecting the environment and…

1 Scope This part of ISO 12402 specifies the safety requirements for lifejackets, performance level 100. It applies to lifejackets used by adults or children. 1DV DT Modification by revising the second sentence of clause 1 to add infants, as follows: It applies to lifejackets used by adults, children, or infants. 1DV.1 DR Addition to clause 1 as follows: 1DV.1.1 Where references are made…

This document sets out the principles and structure for data templates for construction objects. It is developed to support digital processes using machine-readable formats using a standard data structure to exchange information about any type of construction object, e.g. product, system, assembly, space, building etc., used in the inception, brief, design, production, operation and demolition of…

This document specifies the minimum requirements for airworthiness approval of air cargo pallets, nets and containers, generally designated as air cargo unit load devices (ULD). This document is intended to provide a uniform technical reference for air cargo unit load devices approval. As a prerequisite, it is presupposed that the applicable general civil aviation requirements and the aircraft…

alarms intended for protection in non-residential or ordinary (nonhazardous) areas. 1.2 Carbon monoxide alarms covered by these requirements are intended to respond to the presence of carbon monoxide from sources such as, but not limited to, exhaust from internal-combustion engines, abnormal operation of fuel-fired appliances, and fireplaces. Carbon monoxide alarms are intended to alarm at…

This document specifies the characteristics of reference measurement standards of radioactive surface contamination, traceable to national measurement standards, for the calibration of surface contamination monitors. This document relates to alpha-emitters, beta-emitters, and photon emitters of maximum photon energy not greater than 1,5 MeV. It does not describe the procedures involved in the use…

This document gives guidelines for pre-service-inspections (PSI) and in-service inspections (ISI) with mechanized ultrasonic test (UT) devices on components of the reactor coolant circuit of light water reactors. This document is also applicable on other components of nuclear installations. Mechanized ultrasonic inspections are carried out in order to enable an evaluation in case of — fault…