This part of ISO 17510 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.
EN ISO 17510-2:2009 Referenced Document
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*, 2019-11-26 Update
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
EN ISO 17510-2:2009 history
2009EN ISO 17510-2:2009 Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
2003EN ISO 17510-2:2003 Sleep apnoea breathing therapy Part 2: Masks and application accessories ISO 17510-2:2003