Applicable Directives And Standards - Sibelmed S-BASIC Mode D'emploi

S-BASIC User's manual
EN 13

5. APPLICABLE DIRECTIVES AND STANDARDS

• Medical device regulation (EU) 2017/745
• RoHs Directive 2011/65/UE (RD 219/2013)
• Directive 2012/19/UE on Waste from electrical and electronic equipment
(WEEE) (RD 110/2015)
• Audiometry: Allows compliance with standards ISO 8253-1 and ANSI S3.1
depending on environmental conditions.
• Quality: Sibel Quality System (EN ISO 9001:2015 e EN ISO
13485:2016+AC:2018)
• Safety: EN 60601-1:2006+AC:2010 + A1:2013, EN 60601-1-6:2010 +
A1:2015; EN 62366:2008 + A1:2015
• Risk Management: EN ISO 14971:2019
• Information provided by the manufacturer: EN 1041:2008+A1:2013
• Symbols used: EN 15223-1:2016
• Acoustic isolation: EN ISO 11957:2009
501-800-MUM · Rev 2.04