Applicable Directives And Standards - Sibelmed DATOSPIR AIRA Manual De Uso

DATOSPIR
· User's Manual

6. APPLICABLE DIRECTIVES AND STANDARDS

• European Directive of Medical Devices 93/42/CEE
• ROHS Directive 2011/65/EU
• Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE).
• Regulation EC 1272/2008 on classification, labeling and packaging of substances and
mixtures (REACH)
• Regulation EU 207/2012 about electronic instructions
• Quality System (EN ISO 13485:2012+AC:2012, EN ISO 9001:2008)
• Risk Management (EN ISO 14971:2012)
• Safety of medical equipment (EN 60601-1:2006+AC:2010+A11:2011+A1:2013+AC:2014)
• Electromagnetic Compatibility (EN 60601-1-2:2015)
• Bluetooh 2.1 Class II (EN 300328 v2.1.1:2016)
• Biocompatibility: Biological evaluation of medical devices (EN ISO 10993-1:2009+AC:2010)
• Usability (EN 60601-1-6:2010+A1:2015 and EN 62366:2008+A1:2015)
• Medical Device software (EN 62304:2006+AC:2008+A1:2015)
• Documentation and information (EN 1041:2008, EN ISO 15223-1:2016)
• Spirometers for measuring forced expiratory volumes (EN ISO 26782:2009+AC:2009)
• Spirometers for peak expiratory flow (EN ISO 23747:2015)
Spirometry Recommendations
• ATS / ERS:
Miller MR et al. General considerations for lung function testing. Eur Respir J 2005;26:153-161.
Miller MR et al. Standardization of spirometry. Eur Respir J. 2005;26:319-338.
• SEPAR: García-Rio F et al. SEPAR regulations. Spirometry. Arch Bronconeumol
2013;49(9):388-401.
• NLHEP: Ferguson et al. Office Spirometry for Lung Health Assessment in Adults. Chest 2000;117:1146-1161.
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