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

Objeto y campo de aplicación

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.

Información general

Código del comité
CTP 
Nombre del comité
INTECO 
Sector
Salud 
ICS
11.040.10  
Correspondencias
ISO 17510:2015  
Organismos
 
Edición
Fecha de aprobación
2020-04-06 
Número de páginas
40 
Estado
Vigente 

Normas de Referencia
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.