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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 60601-2-4:2010/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
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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)

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$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.
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$85.00
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ANSI/AAMI/IEC 80001-1:2010

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.
$109.00
$192.00
$192.00
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ANSI/AAMI/IEC 80601-2-30:2018

Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
$137.00
$243.00
$243.00
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ANSI/AAMI/IEC 80601-2-58:2014

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
$93.00
$162.00
$162.00
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ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 (PDF)

Amendment 1 to Medical Electrical Equipment Part 2-58
$74.00
$131.00
$131.00

AAMI/IEC TIR80001-2-1:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.
$137.00
$243.00
$243.00
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AAMI/IEC TIR80001-2-2:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls.
$137.00
$243.00
$243.00

ANSI/AAMI/ISO 10993-1:2018

Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
$137.00
$243.00
$243.00
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ANSI/AAMI/ISO 10993-10:2010/(R)2014

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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$243.00
$243.00
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ANSI/AAMI/ISO 10993-11:2017

Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
$114.00
$200.00
$200.00
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ANSI/AAMI/ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
$93.00
$162.00
$162.00
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ANSI/AAMI/ISO 10993-13-2010/(R)2014

Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices.
$65.00
$114.00
$114.00
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ANSI/AAMI/ISO 10993-15:2000/(R)2011

Biological evaluation of medical devices, Part 15: Identification and quantification of degradation products from metals and alloys.
$74.00
$131.00
$131.00
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