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ANSI/AAMI/IEC 60601-1-12:2016 (PDF)

Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
$137.00
$243.00
$243.00
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ANSI/AAMI/IEC 60601-1-2:2014

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
$192.00
$339.00
$339.00
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ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012

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.
$476.00
$840.00
$840.00
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ANSI/AAMI/IEC 60601-2-16:2012

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.
$137.00
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$243.00
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ANSI/AAMI/IEC 60601-2-16:2012 Red-Line (PDF)

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$267.00
$267.00
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ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
$114.00
$200.00
$200.00
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ANSI/AAMI/IEC 60601-2-2:2017 (PDF)

Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
$137.00
$243.00
$243.00
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ANSI/AAMI/IEC 60601-2-20:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
$130.00
$228.00
$228.00
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ANSI/AAMI/IEC 60601-2-21:2009/(R)2014 & A1:2016

Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
$114.00
$200.00
$200.00
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ANSI/AAMI/IEC 60601-2-25:2011/(R)2016

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
$192.00
$339.00
$339.00
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ANSI/AAMI/IEC 60601-2-27:2011/(R)2016

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
$137.00
$243.00
$243.00
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
$160.00
$282.00
$282.00
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version)

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
$160.00
$282.00
$282.00
Available for Immediate Download

ANSI/AAMI/IEC 60601-2-47:2012/(R)2016

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
$137.00
$243.00
$243.00

ANSI/AAMI/IEC 60601-2-50:2009/(R)2014 & A1:2016

Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
$93.00
$162.00
$162.00
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ANSI/AAMI/IEC 62304: 2006 & A1:2016 (Redline) (PDF)

Medical device software—Software life cycle processes
$160.00
$282.00
$282.00
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ANSI/AAMI/IEC 62304:2006 & A1:2016 (PDF)

$137.00
$243.00
$243.00
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ANSI/AAMI/IEC 62366-1:2015 (PDF)

Medical Devices Part 1: Application of Usability Engineering to Medical Devices
$130.00
$228.00
$228.00
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ANSI/AAMI/IEC 80001-1 • Successfully Launching an 80001-1-Based Program

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network. This approach not only identifies the activities necessary to maintain key properties of the network (safety, effectiveness, and security), it also identifies the roles that are needed and the collaboration necessary between a healthcare delivery organization and its networked technology suppliers.
$0.00
$85.00
$85.00
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ANSI/AAMI/IEC 80001-1:2010 (GS Kit Version)

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities, Getting Started kit version.
$44.00
$94.00
$94.00