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Scope Replacement: This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment: ? intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a…

Domaine d’application Remplacement: Le présent document s’applique à la sécurité de base et aux performances essentielles d’un ventilateur à haute fréquence (HFV) associé à ses accessoires, ci-après désignés par appareil EM: ? prévu pour une utilisation dans un environnement qui fournit des soins spécialisés aux patients dont l’état de santé peut mettre leur vie en danger et qui peuvent exiger…

Scope Replacement: This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: — intended for use with patients who can breathe spontaneously; and — intended for patients who would benefit from improved alveolar gas exchange…

Domaine d'application Remplacement: Le présent document s'applique à la sécurité de base et aux performances essentielles des équipements de thérapie respiratoire à haut débit, tels que définis en 201.3.220, ci-après également désignés par appareils EM ou systèmes EM, en association avec leurs accessoires: — destinés à être utilisés sur des patients qui peuvent respirer spontanément…

1 Scope This document establishes the general concepts and principles of IT security evaluation and specifies the general model of evaluation given by various parts of the standard which in its entirety is meant to be used as the basis for evaluation of security properties of IT products. This document provides an overview of all parts of the ISO/IEC 15408 series. It describes the various parts…

1 Scope This document defines the required structure and content of security functional components for the purpose of security evaluation. It includes a catalogue of functional components that meets the common security functionality requirements of many IT products.

1 Scope This document defines the assurance requirements of the ISO/IEC 15408 series. It includes the individual assurance components from which the evaluation assurance levels and other packages contained in ISO/IEC 15408-5 are composed, and the criteria for evaluation of Protection Profiles (PPs), PP-Configurations, PP-Modules, and Security Targets (STs).

Scope This document provides a standardized framework for specifying objective, repeatable and reproducible evaluation methods and evaluation activities.This document does not specify how to evaluate, adopt, or maintain evaluation methods and evaluation activities. These aspects are a matter for those originating the evaluation methods and evaluation activities in their particular area of…

1 Scope This document provides packages of security assurance and security functional requirements that have been identified as useful in support of common usage by stakeholders. EXAMPLE Examples of provided packages include the evaluation assurance levels (EAL) and the composed assurance packages (CAPs). This document presents: — evaluation assurance level (EAL) family of packages that…

Scope This document defines the minimum actions to be performed by an evaluator in order to conduct an ISO/IEC 15408 series evaluation, using the criteria and evaluation evidence defined in the ISO/IEC 15408 series.