59
IEC 60601-1-2:2001+A1:2004
11 EN 60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements
for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
IEC 60601-1-2:2007 (Modified)
12 EN 60601-1-4:1996+A1:1999 Medical electrical equipment -- Part 1-4: General requirements
for safety - Collateral standard: Programmable electrical
medical systems
IEC 60601-1-4:1996 +A1:1999
13 EN 60601-1-6:2004 Medical electrical equipment -- Part 1-6: General requirements
for safety - Collateral standard: Usability
IEC 60601-1-6:2004
14 EN 60601-1-6:2007 Medical electrical equipment -- Part 1-6: General requirements
for basic safety and essential performance - Collateral
Standard: Usability
IEC 60601-1-6:2006
15 EN 60601-1-8:2004+A1:2006 Medical electrical equipment -- Part 1-8: General requirements
for safety - Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and
medical electrical systems
IEC 60601-1-8:2003 +A1:2006
16 EN 60601-1-8:2007 Medical electrical equipment -- Part 1-8: General requirements
for basic safety and essential performance - Collateral
Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical
systems
IEC 60601-1-8:2006
17 EN 60601-2-25:1995+A1:1999 Medical electrical equipment -- Part 2-25: Particular
requirements for the safety of electrocardiographs
IEC 60601-2-25:1993+A1:1999
18
EN 60601-2-51:2003 Medical electrical equipment -- Part 2-51: Particular
requirements for safety, including essential performance, of
recording and analyzing single channel and multichannel
electrocardiographs IEC 60601-2-51:2003
19 EN 62304:2006 Medical device software - Software life-cycle processes
IEC 62304:2006
20 EN 62366:2008 Medical devices - Application of usability engineering to
medical devices IEC 62366:2007
21 MEDDEV.2.7.1 Evaluation of clinical data: A guide for manufacturers and
notified bodies
22 MEDDEV 2.12-1 rev 5 Guidelines on a medical devices vigilance system
A warning label indicates conditions or practices that could lead to injury to patients or
operators
A note label indicates conditions or practices that could damage the equipment)
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