BS EN ISO 17510-1:2009
Sleep apnoea breathing therapy. Sleep apnoea breathing therapy equipment

Standard No.

BS EN ISO 17510-1:2009

Release Date

2009

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 17510-1:2009

Replace

08/30192505 DC:2008 BS EN ISO 17510-1:2007

Scope

IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment (add at the end of the Subclause 1.1): This part of ISO 17510 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. This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates. Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510. This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including: ⎯ ISO 10651-2:2004; ⎯ ISO 10651-3:1997; ⎯ ISO 10651-4:2002; ⎯ ISO 10651-5:2006; ⎯ ISO 10651-6:2004. This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12. 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. See also Figure AA.1.

BS EN ISO 17510-1:2009 Referenced Document

• IEC 60079 Explosive atmospheres - ALL PARTS*， 2018-01-08 Update
• ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices AMENDMENT 1: Revision of Annex E, Single batch release*， 2014-01-01 Update
• ISO 11137 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Technical Corrigendum 1
• ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices*， 2009-10-01 Update
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• ISO 17510-2:2007 Sleep apnoea breathing therapy - Part 2: Masks and application accessories
• ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
• ISO 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices*， 2024-03-01 Update
• ISO 23328-1 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
• ISO 23328-2 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
• ISO 32 Gas cylinders for medical use; Marking for identification of content
• ISO 3744:1994 Acoustics - Determination of sound power levels of noise sources using sound pressure - Engineering method in an essentially free field over a reflecting plane
• ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
• ISO 4871 Acoustics - Declaration and verification of noise emission values of machinery and equipment
• ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets*， 2015-03-01 Update
• ISO 5356-2 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors AMENDMENT 1*， 2012-01-01 Update
• ISO 5359 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases AMENDMENT 1*， 2014-01-01 Update
• ISO 8185:2007 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems
• ISO 9170-1 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum*， 2017-07-01 Update
• ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

BS EN ISO 17510-1:2009 history

• 2020 BS EN ISO 80601-2-70:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
• 2009 BS EN ISO 17510-1:2009 Sleep apnoea breathing therapy. Sleep apnoea breathing therapy equipment