BS EN ISO 17510-1:2007 - Sleep apnoea breathing therapy. Sleep apnoea breathing therapy equipment – BSI British Standards

BS EN ISO 17510-1:2007

Sleep apnoea breathing therapy. Sleep apnoea breathing therapy equipment

Status : Revised, Withdrawn   Published : November 2007 Replaced By : BS EN ISO 17510-1:2009

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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.

Standard NumberBS EN ISO 17510-1:2007
TitleSleep apnoea breathing therapy. Sleep apnoea breathing therapy equipment
StatusRevised, Withdrawn
Publication Date30 November 2007
Withdrawn Date30 April 2009
Normative References(Required to achieve compliance to this standard)IEC 60529, IEC 60601-1-2:2007, IEC 60601-1-8:2006, ISO 11135, ISO 17665, IEC 60601-1:1988, ISO 32:1977, ISO 4871, ISO 9170-1:2017, IEC 60079-4:1975/AMD 1:1995, ISO 15223-1:2007, ISO 17664:2004, IEC 61672, ISO 23328-1, ISO 8185:2007, IEC 60079-4:1975, ISO 17510-2:2007, ISO 14971:2007, IEC 60601-1-1:2000, IEC 60601-1:1988/AMD 1:1991, ISO 5356-1, ISO 23328-2, ISO 4135:2001, IEC 60601-1:1988/AMD 2:1995, ISO/TR 16142:2006, IEC 60601-1-6, ISO 5359, ISO 14937, ISO 5356-2, ISO 11137, ISO 3744:1994
Informative References(Provided for Information)ISO 10651-2, ISO 10651-4, DIN 45681, 93/42/EEC, ISO 10651-6, ISO 10651-3, NFPA 53, ISO 9360, IEC 60601-1-4, IEC 60601-2-12
Replaced ByBS EN ISO 17510-1:2009
ReplacesBS EN ISO 17510-1:2002
International RelationshipsEN ISO 17510-1:2007,ISO 17510-1:2007
DescriptorsInhalation therapy equipment, Flow measurement, Respiratory system, Medical breathing apparatus, Safety measures, Fire resistance, Marking, Medical equipment, Air, Labels, Mechanical testing, Instructions for use, Electrical testing
Title in FrenchThérapie respiratoire de l'apnée du sommeil. Équipement de thérapie respiratoire de l'apnée du sommeil
Title in GermanSchlafapnoe-Atemtherapie. Schlafapnoe-Atemtherapiegeräte
ISBN978 0 580 55213 7
File Size877 KB

*To ask about withdrawn titles contact the
Customer Relations, +44 345 086 9001
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