This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.The requirements in this document take priority over the requirements in ISO 18190.This document does not cover oral appliances.NOTE This document has been prepared to address the relevant essential principles [14] and labelling principles [15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.
Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!
Request your free, no-obligation live demo
I discover COBAZ