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AAMI 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
AAMI 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

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AAMI ANSI/AAMI 2700-2-1:2022
Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
AAMI ANSI/AAMI 2700-2-1:2022

Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging

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AAMI ANSI/AAMI BE83:2006/(R)2011
Biological evaluation of medical devices—Part 18: Chemical characterization of materials
AAMI ANSI/AAMI BE83:2006/(R)2011

Biological evaluation of medical devices—Part 18: Chemical characterization of materials

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AAMI ANSI/AAMI BP22:1994/(R)2016
Blood Pressure Transducers
AAMI ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers

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AAMI ANSI/AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
AAMI ANSI/AAMI CI86:2017

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting

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AAMI ANSI/AAMI CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
AAMI ANSI/AAMI CN27:2021

General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications

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AAMI ANSI/AAMI EC12:2000/(R)2020
Disposable ECG electrodes
AAMI ANSI/AAMI EC12:2000/(R)2020

Disposable ECG electrodes

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AAMI ANSI/AAMI EC53:2013/(R)2020
ECG trunk cables and patient leadwires
AAMI ANSI/AAMI EC53:2013/(R)2020

ECG trunk cables and patient leadwires

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AAMI ANSI/AAMI EC57:2012/(R)2020
Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
AAMI ANSI/AAMI EC57:2012/(R)2020

Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

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AAMI ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 & A2:2021 Redline
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
AAMI ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 & A2:2021 Redline

Medical electrical equipment—Part 1: General requirements for basic safety and essential performance

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AAMI ANSI/AAMI HA60601-1-11:2015/A1:2021
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, Amendment 1
AAMI ANSI/AAMI HA60601-1-11:2015/A1:2021

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, Amendment 1

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AAMI ANSI/AAMI HE75:2025 PDF Preview
AAMI ANSI/AAMI HE75:2025

Human factors engineering—Design of medical devices

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AAMI ANSI/AAMI 60601-1-2:2014/A1:2021
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1
AAMI ANSI/AAMI 60601-1-2:2014/A1:2021

Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1

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AAMI ANSI/AAMI 60601-1-8:2006/A2:2021
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, Amend. 2
AAMI ANSI/AAMI 60601-1-8:2006/A2:2021

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, Amend. 2

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AAMI ANSI/AAMI 60601-2-16:2018
Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
AAMI ANSI/AAMI 60601-2-16:2018

Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

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AAMI ANSI/AAMI 60601-2-2:2017
Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
AAMI ANSI/AAMI 60601-2-2:2017

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

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AAMI ANSI/AAMI 60601-2-25:2011/(R)2016
Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
AAMI ANSI/AAMI 60601-2-25:2011/(R)2016

Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

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AAMI ANSI/AAMI 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
AAMI ANSI/AAMI 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

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AAMI ANSI/AAMI 62304:2006 & A1:2016 (Redline)
Medical device software—Software life cycle processes
AAMI ANSI/AAMI 62304:2006 & A1:2016 (Redline)

Medical device software—Software life cycle processes

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AAMI ANSI/AAMI 62366-1:2015/(R)2021+AMD1:2020 (Consolidated Text) PDF Preview
AAMI ANSI/AAMI 62366-1:2015/(R)2021+AMD1:2020 (Consolidated Text)

Medical devices—Part 1: Application of usability engineering to medical devices + Amendment 1

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AAMI ANSI/AAMI 80001-1:2010
Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.
AAMI ANSI/AAMI 80001-1:2010

Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.

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AAMI ANSI/AAMI 80601-2-30:2018
Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
AAMI ANSI/AAMI 80601-2-30:2018

Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers

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AAMI ANSI/TIR62354:2015
General testing procedures for medical electrical equipment
AAMI ANSI/TIR62354:2015

General testing procedures for medical electrical equipment

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AAMI ANSI/AAMI/ISO 10993-1:2018
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
AAMI ANSI/AAMI/ISO 10993-1:2018

Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

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AAMI ANSI/AAMI/ISO 10993-10:2010/(R)2014
Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
AAMI 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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