BS EN ISO 17510-1:2007 specifies requirements for equipment intended for sleep apnoea breathing therapy fordomiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions. It applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates.
BS EN ISO 17510-1:2007 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient.
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 17510-1:2007 covers basic safety and essential performance requirements needed to protect patients in the use of this equipment.
BS EN ISO 17510-1:2007 is based on IEC 60601-1:1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic document for the safety of medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. It also contains certain requirements for reliable operation to ensure safety. The General Standard has associated Collateral Standards and Particular Standards. The Collateral Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment, such as medical electrical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc.
The Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc.