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AAMI TIR52:2014/(R)2017 (PDF)

Environmental monitoring for terminally sterilized healthcare products
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AAMI TIR55:2014/(R)2017 (PDF)

Human factors engineering for processing medical devices
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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
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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.
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AAMI TIR57:2016

Principles for Medical Device Security - Risk Management
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AAMI TIR58:2014

Water testing methodologies
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AAMI TIR60:2014

Common mode rejection in ECG monitoring
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AAMI TIR61:2014

Generating reports for human factors design validation results for external cardiac defibrillators
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AAMI TIR62:2014

Generating reports for the purpose of submitting defibrillation waveform data for evaluation
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AAMI TIR66:2017

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
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AAMI TIR67:2018 (PDF)

Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
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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
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AAMI TIR69:2017

Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
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AAMI TIR72:2017 (PDF)

Dialysis fluid chemical composition
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AAMI TIR74:2016

Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
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AAMI TIR77:2018 (PDF)

Sorbent-based regenerative hemodialysis systems
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AAMI/IEC TIR60878:2015

Graphic symbols for electrical equipment in medical practice
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AAMI/IEC TIR62366-2:2016

Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices.
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