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    Dispositivos médicos. Terapia respiratoria para la apnea del sueño. Máscaras y accesorios de aplicación.

    Object and field of application

    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.

    General information

    Committee Code
    EN 
    Committee Name
    Endoso 
    Sector
    Salud 
    ICS
    11.040.10  
    Correspondences
    ISO 17510:2015  
    Organism
     
    Edition
    Approval Date
    2020-04-06 
    Number of Pages
    40 
    State
    Vigente 

    Standards Reference
    ISO 3744:2010, ISO 4135:2001, ISO 4871:1996, ISO 5356 1:2015, ISO 5356 2:2012, ISO 10993 1:2009, ISO 14937:2009, ISO 15223 1:2012, ISO 17664:2004, ISO 23328 1:2003, ISO 23328 2:2002, ISO 80601 2-70:2015, IEC 60601-1:2005+A1:2012, IEC 61672-1:2013.

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