Standards Development

Scope

This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. It 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). Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the typical elements of this document together with the sleep apnoea breathing therapy equipment of ISO 80601 -2-70 that form a sleep apnoea breathing system. This document does not cover oral appliances. NOTE This document has been prepared to address the relevant essential principles and labelling principles guidances of the International Medical Devices Regulators Forum (IMDRF).

Purpose

Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep. The awareness of the risks associated with sleep apnoea has grown significantly in recent years. As a result, the use of sleep apnoea breathing therapy equipment has become common. This document covers basic safety and essential performance requirements for masks and other application accessories needed to protect patients during use of this equipment. Millions of patients worldwide use these devic es every night. Perhaps as much as 10% of the world's population suffers from sleep apnoea. These devices are the application accessories for 80601-2-70 medical electrical equipment.

This is not a standard in parts.

This is not a horizontal standard.