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Le présent document traite des questions de qualification de l’installation (IQ), de qualification opérationnelle (OQ), et de qualification des performances (PQ) directement associées au système de fabrication additive qui a une influence directe sur la consolidation du matériau. Les trois premiers éléments de validation du procédé, de cartographie du procédé, d’évaluation du risque, et de…

This document addresses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) issues directly related to the additive manufacturing system that has a direct influence on the consolidation of material. The first three elements of process validation, process mapping, risk assessment, and validation planning, are necessary pre-conditions to machine…

This document provides detailed and rigorous procedures for the independent performance testing of all forms of ship in-water cleaning (IWC), including on all types of biofouling (i.e. biofilms/microfouling and macrofouling), all external submerged surfaces (i.e. hull and niche areas), and both proactive and reactive IWC systems with or without the capture, processing, and disposal of debris.…

This document provides a summary of general guidance for the design of geosynthetics to fulfil the function of stabilization of granular layers in contact with natural soils, fills, asphalt or other materials. The concepts of the summarised guidance are based on installed materials, the installation process and on either the strength or deformation behaviour, or both, of geosynthetics. This…

This document establishes requirements and gives guidance on assurance case framework for healthcare delivery organizations (HDOs) and for health software and medical device manufacturers (MDMs) and can be used to support the communication and information transfer between all parties. An assurance case can be used to communicate information and knowledge about different risks to other roles. This…

This document specifies the following elements for cooperative telematics applications for regulated commercial freight vehicles directly communicating via a secure vehicle interface: a)       a framework for the provision of cooperative telematics application services for regulated commercial freight vehicles; b)       a description of the concept of operation, regulatory aspects and options and…

This document specifies the requirements for a secure interface for the provision of telematics applications for regulated commercial freight vehicles (TARV) application services data to jurisdictions and other relevant parties within the following scenarios: a)       a secure credential management system (SCMS) already exists for ITS data management and access in the location of the service…

This document analyses the processes of image-based systems to be used for tolling purposes, with the aim to identify their specific characteristics, and where these characteristics can be observed. The study intends to answer the following questions: a)       Which are the relevant characteristics of an image-based system used for electronic fee collection (EFC)? b)       How can these…

This document gives general information on the key steps for the preparation of candidate matrix reference materials (RMs) including the material specification, sourcing and selection of bulk material, and the processing of the material, which are important steps for the production of matrix RMs. The document provides information on the preparation of candidate RMs for laboratory staff who…

This document establishes requirements and gives guidance on assurance case framework for healthcare delivery organizations (HDOs) and for health software and medical device manufacturers (MDMs) and can be used to support the communication and information transfer between all parties. An assurance case can be used to communicate information and knowledge about different risks to other roles.…