Health Care and Medical Devices

This document specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use.

This document provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection.

This International Standard specifies basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia.

This International Standard specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.

Amendment.

This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing therapy-equipment.

This Standard provides management requirements for facilities that collect, process, store, and use human blood components for transfusion. It addresses issues of safety, efficacy, and quality for recipients, safety of donors, management of blood components, and safety of facility personnel and others who are exposed to or potentially affected by blood components

Cette norme traite des exigences en matière de gestion pour les établissements qui prélèvent, traitent, entreposent et utilisent les produits sanguins labiles humains à des fins de transfusion. Elle aborde les questions touchant l’innocuité, l’efficacité et la qualité de ces produits pour les receveurs, la sécurité des donneurs, la gestion des produits sanguins labiles et la sécurité du personnel de l’établissement et de toute autre personne exposée aux produits sanguins labiles ou susceptible d’en subir les effets.