ISO 17510:2015
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

Standard No.

ISO 17510:2015

Release Date

2015

Published By

International Organization for Standardization (ISO)

Latest

ISO 17510:2015

Scope

This International Standard applies to masks and their accessories used to connect 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 for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear). Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the typical elements of this International Standard together with the sleep apnoea breathing therapy equipment of ISO 80601-2-70 that form a sleep apnoea breathing system. This International Standard does not cover oral appliances.

ISO 17510:2015 Referenced Document

• IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 14937:2009 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
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• ISO 17510-1:2007 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
• ISO 17510-2:2007 Sleep apnoea breathing therapy - Part 2: Masks and application accessories
• ISO 1766 Textile floor coverings - Determination of thickness of pile above the substrate
• ISO 3744:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane
• ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
• ISO 4871:1996 Acoustics - Declaration and verification of noise emission values of machinery and equipment
• ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors
• 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

ISO 17510:2015 history

• 2015 ISO 17510:2015 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories