ISO 17510-2:2007
Sleep apnoea breathing therapy - Part 2: Masks and application accessories

Standard No.

ISO 17510-2:2007

Release Date

2007

Published By

International Organization for Standardization (ISO)

Latest

ISO 17510-2:2007

Scope

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. Sleep apnoea breathing therapy equipment is covered by ISO 17510-1. See Figure A.1 for typical elements of the two parts of ISO 17510. This part of ISO 17510 does not cover oral appliances.

ISO 17510-2:2007 Referenced Document

• IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems
• IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
• IEC 61672-1 Electroacoustics - Sound level meters - Part 1: Specifications*， 2013-09-01 Update
• 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 17510-1:2007 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
• ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
• 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 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 17510-2:2007 history

• 2007 ISO 17510-2:2007 Sleep apnoea breathing therapy - Part 2: Masks and application accessories
• 2003 ISO 17510-2:2003 Sleep apnoea breathing therapy - Part 2: Masks and application accessories