BS EN ISO 17510-2:2007 - Sleep apnoea breathing therapy. Masks and application accessories – BSI British Standards

BS EN ISO 17510-2:2007

Sleep apnoea breathing therapy. Masks and application accessories

Status : Revised, Withdrawn   Published : November 2007 Replaced By : BS EN ISO 17510-2:2009

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BS EN ISO 17510-2 applies to masks, their fixing and to the accessories used to connect a 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, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear.

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 17510-2 covers basic safety and essential performance requirements needed to protect patients during use of this equipment.

BS EN ISO 17510-2 does not cover oral appliances.

BS EN ISO 17510-2 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 all 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 17510-2:2007
TitleSleep apnoea breathing therapy. Masks and application accessories
StatusRevised, Withdrawn
Publication Date30 November 2007
Withdrawn Date30 April 2009
Normative References(Required to achieve compliance to this standard)ISO 3744:1994, ISO 4135:2001, ISO 4871, ISO 5356-1, ISO 5356-2, ISO 10993, ISO 14937, ISO 14971:2007, ISO 15223-1:2007, ISO 17510-1:2007, ISO 17664:2004, ISO 23328-1, ISO 23328-2, IEC 60601-1:1988, IEC 60601-1-1:2000, IEC 61672-1
Informative References(Provided for Information)ISO/TR 16142, AAMI TIR No. 12-1994, ASTM F1246-91, 93/42/EEC
Replaced ByBS EN ISO 17510-2:2009
ReplacesBS EN ISO 17510-2:2003
International RelationshipsEN ISO 17510-2:2007,ISO 17510-2:2007
Draft Superseded By06/30127484 DC
DescriptorsMedical breathing apparatus, Medical equipment, Respiratory system, Inhalation therapy equipment, Oxygen masks, Air, Flow, Valves, Tubing (medical), Safety measures, Instructions for use
ICS11.040.10
Title in FrenchThérapie respiratoire de l'apnée du sommeil. Masques et accessoires d'application
Title in GermanSchlafapnoe-Atemtherapie. Masken und Anwendungszubehör
CommitteeCH/121/5
ISBN978 0 580 54927 4
PublisherBSI
FormatA4
DeliveryNo
Pages42
File Size1.013 MB
Price£214.00


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