Trex™ HD Monitoring Amplifier
User & Service Manual
8
Table 1 - Safety Standard of Compliance and Normative
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
CAN/CSA C22.2 No 601.1-M90
UL 60601-1:2003
IEC 60601-1:1988 + A1:1991 + A2:1995
Medical Electrical Equipment Part 1: General
Requirements for Safety
IEC 60601-2-26:2012, Edition 3
CENELEC EN 60601-2-26 L2003, Edition 2
CAN/CSA C22.2 No. 60601-2-26-04
IEC 60601-2-26: 2002
Medical Electrical Equipment - Part 2-26: Particular
Requirements for the Safety of Electroencephalographs
CAN/CSA C22.2 No. 60601-1-4-02
IEC 60601-1-4: 1996 + A1: 1999
Medical Electrical Equipment - Part 1-4: General
Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems
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
IEC 60601-1-6:2010, Edition 3.0
CAN/CSA C22.2 No. 60601-1-6-05
IEC 60601-1-6: 2004
Medical Electrical Equipment - Part 1-6: General
requirements for safety - Collateral Standard: Usability
IEC 62366:2007, Edition 1.0
Medical devices – Application of usability engineering to
medical devices
IEC 60601-1-11:2010, Edition 1.0
Medical electrical equipment – Part 1-11: General
requirements for basic safety and essential performance
– Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems
used in the home healthcare environment
CAN/CSA C22.2 No. 60601-1-1-02
IEC 60601-1-1: 2000
Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety
Requirements for Medical Electrical Systems