DATOSPIR TOUCH User’s Manual 56
511-B00-MU2 • REV. 1 .09
Electromagnetic Compatibility EMC – Healthcare Environment
(EN 60601-1-2:2015)
Biocompatibility: Biological evaluation of medical devices.
(EN ISO 10993-1: 2009+AC: 2010)
Usability (EN 60601-1-6:2010+A1:2015)
Usability (EN 62366:2008+A1:2015)
Spirometers for forced spiratory volumes measurement
(EN ISO 26782:2009+AC:2009)
Spirometers for peak spiratory flow (EN ISO 23747:2015)
Software of medical devices (EN 62304:2006+AC:2008+A1:2015)
Pulsioximetry (EN ISO 80601-2-61:2011)
Vibration and temperature: (Series EN 60721:1995 and Series
EN 60068:1999)
Documentation and information (EN 1041:2008,
EN ISO15223-1:2016, EN 980:2008)
Waste disposal according to WEEE Directive 2012/19/UE.
Electronic Device: 2011/65/EU Rohs Directive (starting on
July 22nd, 2014)
Spirometry standards
in force
ATS/ ERS Standards:
1.
Miller MR, Crapo R, Hankinson J, et al. General
considerations for lung function testing. Eur Respir J 2005;
26:153–161.
2. Miller MR, Hankinson J, Brusasco V, et al. Standardisation
of spirometry. Eur Respir J .2005; 26: 319–338.
3. V. Brusasco, R. Crapo and G. Viegi. Standardisation of the
measurement of lung volumen Eur Respir J 2005; 26:
511-522
SEPAR: Sanchis et al Normativa para la espirometría forzada.
Recomendaciones SEPAR núm. 1. Arch Bronconeumol 1989;
25: 132-142.
NLHEP: Ferguson et al. Office Spirometry for Lung
Health Assessment in Adults. Chest 2000; 117:1146-1161.