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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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$1,060.00
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AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
$93.00
$162.00
$162.00
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AAMI TIR57:2016/(R)2019

Principles for medical device security—Risk management
$168.00
$282.00
$282.00
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AAMI TIR60:2014/(R)2019

Common mode rejection in ECG monitoring
$74.00
$131.00
$131.00
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AAMI/IEC TIR60878:2015

Graphic symbols for electrical equipment in medical practice
$246.00
$436.00
$436.00

AAMI/IEC TIR61289:2011

High frequency surgical equipment - Operation and maintenance.
$93.00
$162.00
$162.00

AAMI/IEC TIR62296:2009

Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
$133.00
$222.00
$222.00

AAMI/IEC TIR62354:2015

General testing procedures for medical electrical equipment
$260.00
$458.00
$458.00

AAMI/IEC TIR62366-2:2016

Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices.
$160.00
$282.00
$282.00

AAMI/IEC TIR80001-2-3:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
$130.00
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$228.00

AAMI/IEC TIR80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations.
$93.00
$162.00
$162.00

AAMI/IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems
$114.00
$200.00
$200.00

AAMI/IEC TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
$74.00
$131.00
$131.00

AAMI/IEC TIR80001-2-6:2014 (PDF)

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AAMI/IEC TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
$160.00
$282.00
$282.00

AAMI/IEC TIR80001-2-8:2016 (PDF)

$137.00
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$243.00
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AAMI/IEC TIR80002-1:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
$129.00
$243.00
$243.00

AAMI/IEC TIR80002-3:2016

Technical Information Report Medical Device Software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
$114.00
$200.00
$200.00

AAMI/ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
$111.00
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$194.00
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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.
$192.00
$339.00
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