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2010 Human Factors Horizons

Human factors engineering is concerned with understanding the interactions among humans and other elements of a system. How can the principles of human factors be used to improve the design, use, and management of medical devices? How can we reduce medical errors and increase patient safety by improving the interface between healthcare practitioners and medical technology?
AAMI Member:
$22.00
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$36.00
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A Comprehensive Overview of the Current FDA Guidances and International Standards for Medical Device Software (Webinar On Demand)

With the extensive and rapidly evolving use of software in today’s medical devices, it is important for industry professionals to understand the implications of regulatory requirements for medical device software and to be aware of the many guidances and standards that are available to industry on this important topic.
AAMI Member:
$315.00
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$415.00
Available for Immediate Download
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AAMI TIR12:2010

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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$125.00
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$222.00
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AAMI TIR12:2010 Red-line (PDF Format)

Includes Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and red-line format of document showing changes between the current and 2004 version in red and strikethrough, PDF format.

To preview this file click here.
AAMI Member:
$135.00
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$230.00
Available for Immediate Download
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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
AAMI Member:
$125.00
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$222.00
Available for Immediate Download
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AAMI TIR36:2007

Validation of software for regulated processes
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$146.00
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$258.00
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AAMI TIR49:2013

Design of training and instructional materials for medical devices used in non-clinical environments
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$104.00
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$183.00
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AAMI TIR59:2017 (PDF)

Integrating human factors into design controls
AAMI Member:
$104.00
List Price:
$183.00
Available for Immediate Download
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AAMI TIR65:2015

Sustainability of medical devices-Elements of a responsible product life cycle
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$118.00
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$208.00
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AAMI/ISO TIR14969:2004

Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003
AAMI Member:
$125.00
List Price:
$222.00
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AAMI/ISO TIR22442-4:2011/(R)2016

Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes.
AAMI Member:
$84.00
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$148.00
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AAMI/ISO TIR23810:2012/(R)2015

Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup.
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$104.00
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$183.00
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AAMI/ISO TIR80002-2:2017 (PDF)

Medical device software—Part 2: Validation of software for medical device quality systems
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$146.00
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$258.00
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An FMEA Trifecta: sFMEA, dFMEA, & pFMEA (Webinar On Demand)

If you perform a System-Level Failure Mode & Effects Analysis (sFMEA), a Design FMEA (dFMEA), and a Process FMEA (pFMEA), then they can be linked to become a robust risk-analysis tool set. Linking these three tools can be considered a trifecta* • a safe bet on risk mitigation. A successful trifecta is great cause for celebration • risk and product managers can finally rest easy!
AAMI Member:
$315.00
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$415.00
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Anatomy and Physiology

This anatomy and physiology courses were designed to familiarize today's biomedical technician with the basic human body systems and their functions. A thorough understanding of how these systems function will assist greatly in troubleshooting various medical instruments designed to diagnose and monitor them. The level of detail in these courses is on par with what a biomedical technician would need to know, but without the same exhaustive detail that would be necessary for a medical professional. This course was developed using a proved, accredited curriculum and would be a benefit to more experienced BMETs as well as those new in the field. Three discs total 203 minutes.
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$316.00
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$390.00
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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$67.00
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$119.00
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
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$67.00
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$119.00
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ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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$146.00
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$258.00
Available for Immediate Download
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ANSI/AAMI HE75:2013

Human Factors Engineering - Design of Medical Devices
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$221.00 - $312.00
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$390.00 - $551.00
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ANSI/AAMI ST40:2004/(R)2010

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities.
AAMI Member:
$111.00
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$185.00 - $195.00
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