User & Service Manual
Xltek® Trex HD Amplifier
9
CAN /CSA-C22.2 No. 60601-1: 08(R2013) +
C2:2011
ANSI/AAMI ES60601-1:2005/(R)2012 +
C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1:2005 + C1:2006 and C2:2007,
Third Edition
CENELEC EN 60601-1:2006 + A1:2013
Medical electrical equipment
– Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-6:2010, Edition 3.0
Medical electrical equipment
– Part 1-6: General
requirements for basic safety and essential performance
– Collateral standard: Usability
IEC 62366:2007, Edition 1.0
Medical devices
– Application of usability engineering to
medical devices
IEC 60601-2-26:2012, Edition 3
CENELEC EN 60601-2-26L2003, Edition 2
Medical electrical equipment
– Part 2-26: Particular
requirements for the safety of electroencephalographs
EN ISO 80601-2-61:2011, Edition 1
Medical electrical equipment
– Part 2-61: Particular
requirements for basic safety and essential performance
of pulse oximeter equipment
Table 2 - EMC Standard of Compliance and Normative References
IEC 60601-1-2, Edition 4.0, February
1, 2014
Medical electrical equipment
– Part 1-2: General requirements
for basic safety and essential performance
– collateral standard:
electromagnetic compatibility
– requirements and tests
IEC 61000-4-2:2008, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-2: Testing and
Measurement Techniques - Electrostatic Discharge Immunity
Test
IEC 61000-4-3 ed 3.0 with
A1:2007+A2:2010
Electromagnetic Compatibility (EMC) Part 4-3: Testing and
Measurement Techniques - Radiated, Radio-frequency,
Electromagnetic Field Immunity Test
IEC 61000-4-4:2012, ed 3.0
Electromagnetic Compatibility (EMC) Part 4-4: Testing and
Measurement Techniques - Electrical Fast Transient/Burst
Immunity Test
IEC 61000-4-5:2014, ed 3.0
Electromagnetic Compatibility (EMC) Part 4-5: Testing and
Measurement Techniques - Surge Immunity Test
IEC 61000-4-6 ed 2.0 with A1:2004 +
A2:2006
Electromagnetic Compatibility (EMC) Part 4-6: Testing and
Measurement Techniques - Immunity to Conducted
Disturbances, Induced by Radio-frequency Fields
IEC 61000-4-8:2009, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-8: Testing and
Measurement Techniques - Power Frequency Magnetic Field
Immunity Test
IEC 61000-4-11:2004, ed 2.0
Electromagnetic Compatibility (EMC) Part 4-11: Testing and
Measurement Techniques - Voltage Dips, Short Interruptions
and Voltage Variations Immunity Tests
IEC 61000-3-2:2014, ed 4.0
Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits for
