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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 TIR11:2005/(R)2015

Selection and use of protective apparel and surgical drapes in health care facilities
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$104.00
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$183.00
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AAMI TIR21:2017 (PDF)

Systems used to forecast remaining pacemaker battery service life
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AAMI TIR44:2012

Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
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AAMI TIR49:2013

Design of training and instructional materials for medical devices used in non-clinical environments
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AAMI TIR60:2014

Common mode rejection in ECG monitoring
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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
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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
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$117.00
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$222.00
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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$67.00
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$119.00
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ANSI/AAMI BF64:2012

Leukocyte reduction filters.
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$67.00
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$119.00
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ANSI/AAMI BF7:2012

Blood transfusion micro-filters.
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$67.00
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$119.00
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
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$67.00
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$119.00
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ANSI/AAMI EC12:2000/(R)2015

Disposable ECG electrodes
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$84.00
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$148.00
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ANSI/AAMI EC53:2013

ECG cables and leadwires.
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$67.00
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ANSI/AAMI EC57:2012

Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms.
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ANSI/AAMI ES60601-1:2005/(R)2012 (Travel Edition)

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$579.00
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$973.00
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ANSI/AAMI ES60601-1:2005/A1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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$146.00
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$258.00
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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.
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$310.00
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ANSI/AAMI NS28:1988/(R)2015 (PDF)

Intracranial pressure monitoring devices
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ANSI/AAMI NS4:2013/(R)2017 (PDF)

Transcutaneous electrical nerve stimulators
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$119.00
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