Applicable Directives And Standards - Sibelmed Somnibel Pro Manuel D'utilisateur

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6. APPLICABLE DIRECTIVES AND STANDARDS

• European directive concerning medical devices 93/42/EEC
• Rohs Directive: 2011/65/EU.
• Waste disposal according to WEEE Directive 2012/19/UE.
• Regulation EC 1272/2008 on classification, labeling and packaging of substances and mixtures (REACH).
• Packaging and packaging waste directive 94/62/ EC modified by 2004/12/EC
• Batteries waste directive 2006/66/EC modified by 2013/56/EU.
• Quality (EN ISO 13485:2016+AC:2018, EN ISO 9001:2015)
• Risk management (EN ISO 14971:2012)
• Safety Medical devices (EN 60601-1:2006+AC:2010+A1:2013+AC:2014)
• Safety Medical devices – Batteries (EN 62133:2013).
• Safety Medical devices – Home use (EN 60601-1-11:2015).
• Electro-magnetic Compatibility (EN 60601-1-2:2015; home and healthcare environment)
• 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)
• Software of medical devices (EN 62304:2006+AC:2008+A1:2015)
• Documentation and information (EN 1041:2008 and EN ISO 15223-1:2016)
EN 20
534-80P-MUM_Rev.1.08