T E C H N I C A L S P E C I F I C A T I O N S
MyLab
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Standards
Table 9-3: Standards
Standard
Title
IEC 60601-1:2012 (Ed.3.1)
EN 60601-1:2006 + CORR. 1
(2006) + CORR. 2 (2007) +
AMD. 1 (2015)
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
CAN/CSA C22.2 No. 60601-1:08
CAN/CSA C22.2 No. 60601-1.14
Medical Electrical Equipment - Part 1: General
Requirements for Safety
ANSI/AAMI ES60601-1: 2005 +
A2:2010
Medical Electrical Equipment - Part 1: General
Requirements for Safety
IEC 60601-1-2:2014 (Ed.4)
EN 60601-1-2:2015 (Ed.4)
Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral Standard:
Electromagnetic compatibility - Requirements and
tests
IEC 60601-1-6:2010 + A1:2013
(Ed. 3.1)
EN 60601-1-6:2010 + A1:2015
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance – Collateral standard: Usability
IEC 60601-2-37:2007 (Ed. 2.1) +
A1:2015
EN 60601-2-37:2008
Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment
IEC 61157:2007 (Ed. 2.1)
+A1:2013
Standard means for the reporting of the acoustic
output of medical diagnostic ultrasonic equipment
IEC 62304
EN 62304
Medical device software - Software life cycle
processes
IEC 62366:2007 + A1:2014 (Ed.
1.1)
EN 62366:2008
Application of Usability Engineering to Medical
Devices
EN ISO 10993-1:2009
Biological evaluation of medical devices -
Evaluation and testing
EN ISO 14971:2012
Medical equipment - Application of risk
management to medical devices.
ISO 15223-1
Medical devices - Symbols to be used with medical
device labels, labelling and information to be
supplied - Part 1: General Requirements
AIUM/NEMA UD-2:2004
(R2009)
Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment.
Summary of Contents for MyLabOmega
Page 1: ...Rev 04 July 2019 MyLabOmega GETTING STARTED 350035100...
Page 2: ...MyLab G E T T I N G S T A R T E D ii...
Page 5: ...MyLab G E T T I N G S T A R T E D v GETTING STARTED EC Declaration of Conformity...
Page 6: ...MyLab G E T T I N G S T A R T E D vi RED Declaration of Conformity...
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Page 14: ...I N D E X MyLab G E T T I N G S T A R T E D xiv...
Page 26: ...I N T R O D U C T I O N MyLab G E T T I N G S T A R T E D 1 12...
Page 52: ...S Y S T E M O V E R V I E W MyLab G E T T I N G S T A R T E D 3 18...
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