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  • ISO 17510-1:2007

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  20-09-2018

    Language(s):  English, French, Russian

    Published date:  25-09-2007

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 17510-1:2007 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.

    ISO 17510-1:2007 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 ISO 17510-1:2007.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/FDIS 17510-1. (10/2007)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    CSA Z17510.2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
    DIN EN ISO 17510-2:2009-07 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
    I.S. EN ISO 17510-2:2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
    16/30295446 DC : 0 BS ISO 19223 - LUNG VENTILATORS AND RELATED EQUIPMENT - VOCABULARY AND SEMANTICS
    UNI EN ISO 17510-2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
    ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
    ISO 17510-2:2007 Sleep apnoea breathing therapy Part 2: Masks and application accessories
    EN ISO 17510-2:2009 Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
    BS EN ISO 17510-2:2009 Sleep apnoea breathing therapy Masks and application accessories

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 4871:1996 Acoustics — Declaration and verification of noise emission values of machinery and equipment
    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 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
    ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
    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
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 10651-3:1997 Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    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 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 9360-2:2001 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
    IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    DIN 45681:2005-03 ACOUSTICS - DETERMINATION OF TONAL COMPONENTS OF NOISE AND DETERMINATION OF A TONE ADJUSTMENT FOR THE ASSESSMENT OF NOISE IMMISSIONS
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 17510-2:2007 Sleep apnoea breathing therapy Part 2: Masks and application accessories
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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