BS EN ISO 17510-1:2009 Sleep apnoea breathing therapy. Sleep apnoea breathing therapy equipment
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.
BS EN ISO 17510-1 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.
BS EN ISO 17510-1 applies to equipment intended for use with adults and children, but excludes equipment intended for use with neonates.
Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510.
ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient.
Contents of BS EN ISO 17510-1:
Foreword
Introduction
Scope
Normative references
Terms and definitions
Requirements
Classification and designation
Marking, labelling and packaging
Power input
Basic safety categories
Removable protective means
Environmental conditions
Not used
Not used
General
Requirements related to classification
Limitation of voltage and/or energy
Enclosures and protective covers
Separation
Protective earthing, functional earthing and potential equalization
Continuous leakage currents and patient auxiliary currents
Dielectric strength
Mechanical strength
Moving parts