Rechercher

This document specifies: —     the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments; —     the general categorization of gas pathways based on the nature and duration…

This Standard specifies minimum requirements for the acceptable and responsible collection and use of contact tracing and monitoring data in the workplace. This Standard applies to the governance of current and future use of data that is created, collected, stored or controlled by contact tracing and monitoring solutions, and impacts the management processes and decisions relating to data…

This document describes a test method that covers the determination of fracture resistance of monolithic ceramics at room temperature by the indentation fracture (IF) method. This document is intended for use with dense monolithic ceramics and whisker- or particulate-reinforced ceramics which are regarded as macroscopically homogeneous. It does not include monolithic silicon nitride ceramics for…

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data…

ISO 18562-1:2017 specifies: - the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments; - the general categorization of gas pathways based on the nature and…

ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the…

Scope O80.0-1.1 This Standard sets forth requirements for materials, analysis of materials, and operational practices for pressure and thermal impregnation for the chemical preservation of wood. 1.2 The recommendations made in this Standard are based solely on the efficacy of the preservative in any specific application. As preservatives and their uses are regulated by government…

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data…

This document describes a test method that covers the determination of fracture resistance of monolithic ceramics at room temperature by the indentation fracture (IF) method. This document is intended for use with dense monolithic ceramics and whisker- or particulate-reinforced ceramics which are regarded as macroscopically homogeneous. It does not include monolithic silicon nitride ceramics for…