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ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD)

This standard incorporates Amendment 1 with changes highlighted in the text.
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AAMI/IEC TIR60878:2015

Graphical symbols for electrical equipment in medical practice.



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AAMI/IEC TIR60878:2015 (PDF Format)

Graphical symbols for electrical equipment in medical practice.



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AAMI/IEC TIR62366-2: 2016

Medical devices—Part 2: Guidance on the application of usability engineering to medical devices.
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AAMI/IEC TIR62366-2: 2016 (PDF Version)

Medical devices—Part 2: Guidance on the application of usability engineering to medical devices.
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AAMI/IEC TIR80001-2-8:2016 (PDF)

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AAMI/IEC TIR80002-3: 2016 (PDF Version)

Technical Information Report Medical device software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
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ANSI/ AAMI/IEC 62304:2006/ A1:2015 (PDF)

Medical device software— Software life cycle processes.

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ANSI/AAMI ES60601-1:2005/A1:2012

ANSI/AAMI ES60601-1:2005/A1:2012 & C1:2009/(R)2012 & A2:2010/(R)2012
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ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)

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.
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ANSI/AAMI NS4:2013

Transcutaneous electrical nerve stimulators
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ANSI/AAMI/IEC 60601-1-12:2016 (PDF Version)

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.
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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.
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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.
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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.
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ANSI/AAMI/IEC 60601-2-16:2012 Red-Line (PDF Format)

New! Includes Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment and Red-Line format of document showing changes between the current and 2008 version in red and strikethrough. PDF format.

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ANSI/AAMI/IEC 60601-2-19:2009

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ANSI/AAMI/IEC 60601-2-19:2009/A1:2016 (PDF)

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ANSI/AAMI/IEC 60601-2-2:2009

Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
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