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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/(R)2019

Principles for medical devices security—Risk management
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AAMI TIR61:2014/(R)2019

Generating reports for human factors design validation results for external cardiac defibrillator
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AAMI TIR62:2014/(R)2019

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 TIR75:2019

Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
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AAMI TIR97:2019

Principles for medical device security—Postmarket risk management for device manufacturers
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AAMI/IEC TIR62354:2015

General testing procedures for medical electrical equipment
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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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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
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AAMI/IEC TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
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AAMI/IEC TIR80001-2-6:2014 (PDF)

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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 TIR80001-2-8:2016 (PDF)

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AAMI/ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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