Scope

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 with PATIENTS who have VENTILATORY IMPAIRMENT, the most fragile of these PATIENTS, would not likely experience injury with the loss of this artificial ventilation; and — not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 PATIENTS with mild to moderate chronic obstructive pulmonary disease (COPD). .

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	SC 3