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AAMI TIR39:2009/(R)2017 (PDF)

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
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AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
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$126.00
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$221.00
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$221.00
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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
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$90.00
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$157.00
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AAMI TIR45:2012, Guidance on the use of AGILE practices Webinar

This webinar archive provides detailed information about AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software and its recommendations for complying with international standards and FDA guidance documents when using AGILE practices to develop medical device software.
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$119.00
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$199.00
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AAMI TIR45:2012/(R)2018

Guidance on the use of AGILE practices in the development of medical device software
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$129.00 - $133.00
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$229.00 - $236.00
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$229.00 - $236.00
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AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
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$155.00
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$274.00
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AAMI TIR50:2014/(R)2017 (PDF)

Post-market surveillance of use error management
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$111.00
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$194.00
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$194.00
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AAMI TIR51:2014/(R)2017 (PDF)

Human factors engineering - Guidance for contextual inquiry
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$72.00
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AAMI TIR55:2014/(R)2017 (PDF)

Human factors engineering for processing medical devices
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$90.00
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$157.00
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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
AAMI Member:
$90.00
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$157.00
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$157.00
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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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$119.00
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$199.00
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AAMI TIR57:2016

Principles for Medical Device Security - Risk Management
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$163.00
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$274.00
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$274.00
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AAMI TIR63: 2014/(R)2017 (PDF)

Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
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$63.00
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$111.00
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AAMI TIR65:2015

Sustainability of medical devices-Elements of a responsible product life cycle
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$126.00
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$221.00
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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
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$90.00
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$157.00
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$157.00
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AAMI TIR69:2017

Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
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$133.00
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$236.00
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$236.00
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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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$111.00
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$194.00
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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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$72.00
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AAMI/IEC TIR80001-2-6:2014 (PDF)

AAMI Member:
$72.00
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$127.00
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$127.00
Available for Immediate Download
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