Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential per...
Scope
IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by:
This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home…
Appareils électromédicaux — Partie 2-67 : Exigences particulières pour la sécurité de base et les pe...
Domaine d'application
L'IEC 60601-1:2005+AMD1:2012, 1.1 est remplacé par:
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un économiseur d'oxygène, désigné ci-après sous le terme d'appareil EM, ainsi que de ses accessoires prévus pour économiser le supplément d'oxygène en délivrant du gaz de manière intermittente et…
Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential per...
Scope
Replacement:
This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those…
Appareils électromédicaux — Partie 2-74 : Exigences particulières pour la sécurité de base et les pe...
Domaine d'application
Remplacement:
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un humidificateur, ci-après également désigné par appareil EM, associé à ses accessoires, dont la combinaison est ci-après désignée par système EM.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être raccordés à…
Appareils électromédicaux — Partie 2-90 : Exigences particulières pour la sécurité de base et les pe...
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…
Information security, cybersecurity and privacy protection — Evaluation criteria for IT security — P...
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…
Information security, cybersecurity and privacy protection — Evaluation criteria for IT security — P...
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.
Information security, cybersecurity and privacy protection — Evaluation criteria for IT security — P...
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).
Information security, cybersecurity and privacy protection — Evaluation criteria for IT security — P...
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…
Information security, cybersecurity and privacy protection — Evaluation criteria for IT security — P...
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…