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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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AAMI TIR21:2017/(R)2020

Systems used to forecast remaining pacemaker battery service life
$137.00
$243.00
$243.00
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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
$93.00
$162.00
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AAMI TIR49:2013/(R)2020

Design of training and instructional materials for medical devices used in non-clinical environments
$130.00
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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 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 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

ANSI/AAMI 2700-1:2019

Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
$114.00
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
$74.00
$131.00
$131.00

ANSI/AAMI EC12:2000/(R)2015

Disposable ECG electrodes
$74.00
$131.00
$131.00

ANSI/AAMI EC53:2013 (PDF)

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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)

$622.00
$1,060.00
$1,060.00

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

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
$170.00
$282.00
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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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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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ANSI/AAMI PB70:2012

ANSI/AAMI PB70 provides manufacturers with a consistent basis for creating device labeling claims regarding barrier efficacy against liquid-borne microorganisms. Through labeling requirements, the standard is also intended to assist end-users in selecting the appropriate protective apparel and drapes to inhibit the transfer of microorganisms associated with blood, body fluids, and other potentially infectious materials.
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ANSI/AAMI PB70:2012 Red-Line (PDF)

$110.00
$195.00
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