Agency Compliance Appendix
6 - 14 0070-10-0699-02 Accutorr V Operating Instructions
6.6 Agency Compliance
This monitor is designed to comply with the following agency standards:
Safety, IEC EN 60601-1:1990 +A1:1993 + A2:1995
+A13:1996 / IEC 60601-1:1988 +A1:1991
+A2:1995
Safety, UL UL 60601-1:2003
Safety, Canada CAN/CSA C22.2 No. 601.1-M90 (R2005)
Safety, collateral EN 60601-1-1:2001 / IEC 60601-1-1:2000
Multifunction EN 60601-2-49:2001 / IEC 60601-2-49:2001
SpO
2
particular ISO 9919:2005
NIBP, particular EN 60601-2-30:2000 / IEC 60601-2-30:1999
NIBP, IEC EN 1060-1:1995 +A1:2002
NIBP, supplementary EN 1060-3:1997 +A1:2005
NIBP, USA ANSI/ AAMI SP-10:1992 + A1:1996
Programmable EN 60601-1-4:1996 +A1:1999
IEC 60601-1-4:1996 +A1:1999
Temperature ASTM E1112-00:2006
Biological ISO 10993-1:2003
Risk EN 14971:2000 +A1:2007
Acoustics EN 60601-1-8:2006
Random Vibe EN 60068-2-64:1994 / IEC 60068-2-64:1993
+Corr.1:1993
Shock EN 60068-2-27:1993 /IEC 60068-2-27:1987
Ingress EN 60529:1991 +A1:2000
Shipping ISTA Procedure 2A:2008
Drop and Impact ECRI PB 296892:1979
EMC EN 60601-1-2:2001 +A1:2004/IEC 60601-1-
2:2007 +A1:2004
Radiated and Conducted Emissions EN 55011:2007 +A2:2007
Sinusoidal Vibration IEC 60068-2-6:1995
Usability IEC 60601-1-6:2004
Clinical Thermometers Part 3: Performance
of Compact Electrical Thermometers (non-
predictive and predictive) with maximum
device
EN 12470-3:2000
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