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AAMI TIR55:2014/(R)2017 (PDF)

Human factors engineering for processing medical devices
$93.00
$162.00
$162.00
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AAMI TIR56:2013/(R)2016 (PDF)


Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
$93.00
$162.00
$162.00
Available for Immediate Download

AAMI TIR57: Principles for Medical Device Security--Risk Management Webinar

This webinar, led by the co-chairs of the committee who developed TIR57, outlines the document and its application to your business. TIR57 provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971.
$119.00
$199.00
$199.00
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AAMI TIR57:2016/(R)2019

Principles for medical device security—Risk management
$168.00
$282.00
$282.00
Available for Immediate Download

AAMI TIR61:2014/(R)2019

Generating reports for human factors design validation results for external cardiac defibrillator
$74.00
$131.00
$131.00
Available for Immediate Download

AAMI TIR62:2014/(R)2019

Generating reports for the purpose of submitting defibrillation waveform data for evaluation
$65.00
$114.00
$114.00
Available for Immediate Download

AAMI TIR66:2017/(R)2020

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
$114.00
$200.00
$200.00
Available for Immediate Download

AAMI TIR67:2018 (PDF)

Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
$137.00
$243.00
$243.00
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AAMI TIR68:2018 (PDF)

Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
$0.00
$0.00
$0.00
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AAMI TIR69:2017/(R)2020

Risk management of radio-frequency wireless coexistence for medical devices and systems
$137.00
$243.00
$243.00
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AAMI TIR71:2017/(R)2020

Guidance for logging of alarm system data
$74.00
$131.00
$131.00
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AAMI TIR75:2019

Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
$114.00
$200.00
$200.00
Available for Immediate Download

AAMI TIR97:2019

Principles for medical device security—Postmarket risk management for device manufacturers
$137.00
$243.00
$243.00
Available for Immediate Download

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 TIR80001-2-5:2014

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)

$74.00
$131.00
$131.00
Available for Immediate Download

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
$243.00
$243.00
Available for Immediate Download