Applicable Directives And Standards - Sibelmed S-PREMIUM Manual Del Usuario

Frequency D'p
(octave third)
f dB
Hz
100 18,5
125 24,2
160 16,6
200 22,5
250 31,4
315 23,5
400 23,6
500 31,9
630 33,6
800 33,7
1000 34,4
1250 34,9
1600 34,6
2000 33,4
2500 35,7
3150 36,9
4000 39,3
5000 41,2
6300 42,1
8000 43,6
10000 43,4
Test performed according to EN ISO 11957:2009

4. APPLICABLE DIRECTIVES AND STANDARDS

• European Medical Devices Directive 93/42/CEE
• RoHs Directive 2011/65/UE
• Directive 2002/96/EC on waste of electrical and electronic equipment (WEEE)
• Audiometry: Allows the fulfillment of ISO 8253-1 and ANSI S3.1 depending
on surrounding conditions
• Quality: Sibel's Quality Sistem (EN ISO 9001:2015 and EN ISO
13485:2016+AC:2016)
• 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 14971:2012
• Information provided by the manufacturer: EN 1041:2008
• Symbols used: EN 15223-1:2016
• Acoustic insulation: EN ISO 11957:2009
S-PREMIUM User's manual
501-900-MUM · Rev 1.01
EN 10