1 Domaine d’application
1.1
Cette norme vise le retraitement sécuritaire, efficace et fiable des dispositifs médicaux réutilisables à
chaque étape du déroulement des travaux de retraitement, y compris
a) l’établissement d’un SGQ applicable à un SRDM, y compris :
i) les indicateurs de performance clés;
ii) les politiques et les modes opératoires;
iii) la documentation;
iv) les rôles et…
Fabrication additive — Conception — Exigences, lignes directrices et recommandations
Le présent document donne les exigences, les lignes directrices et les recommandations relatives à l'utilisation de la fabrication additive (FA) dans la conception des produits.
Il est applicable lors de la conception de tous les types de produits, dispositifs, systèmes, composants ou pièces devant être manufacturés par tout type de système FA. Le présent document aide à déterminer les…
Guidance on the selection of the appropriate means of ventilation based on the intended patient, use...
ISO TR 21954:2018 This document considers and identifies criteria about the intended patient, intended use environment, and intended operator across the spectrum of the types of ventilation-related equipment as listed below:
— gas-powered resuscitator as specified in ISO 10651-5[1] [1];
— operator-powered resuscitator as specified in ISO 10651-4[2];
— ventilator for critical care as specified…
Guidance on the selection of the appropriate means of ventilation based on the intended patient, use...
This document considers and identifies criteria about the intended patient, intended use environment, and intended operator across the spectrum of the types of ventilation-related equipment as listed below:
— gas-powered resuscitator as specified in ISO 10651-5[1] [1];
— operator-powered resuscitator as specified in ISO 10651-4[2];
— ventilator for critical care as…
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential per...
ISO 80601-2-79:2018 This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator; and
— intended for use…
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential per...
ISO 80601-2-80:2018 This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator;
— intended for use…
Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential per...
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator; and
— intended for…
Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential per...
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator;
— intended for…
Tests on electric and optical fibre cables under fire conditions - Part 3-25: Test for vertical flam...
IEC 60332-2-25:2018 covers category D for methods of test for the assessment of vertical flame spread of vertically mounted bunched wires or cables, electrical or optical, under defined conditions. This document relates only to small cables of overall diameter 12 mm or smaller and cross-section of 35 mm2 or smaller installed on the test ladder to achieve a nominal total volume of non-metallic…
Essais des câbles électriques et des câbles à fibres optiques soumis au feu - Partie 3-25: Essai de ...
L’IEC 60332-2-25:2018 couvre la catégorie D pour les méthodes d'essai pour l'évaluation de la propagation verticale de la flamme des fils ou câbles, électriques ou optiques, disposés en nappes en position verticale, dans des conditions définie. Le présent document ne concerne que les petits câbles de diamètre extérieur inférieur ou égal à 12 mm et de section inférieure ou égale à 35 mm2…