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AAMI/ISO TIR16142-1:2016

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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$133.00
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$236.00
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$236.00
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ANSI/AAMI/ISO 16142-2:2017 (PDF)

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
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$133.00
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$236.00
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$236.00
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ANSI/AAMI/ISO 25539-3:2011/(R)2015

Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters.
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$151.00 - $155.00
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$251.00 - $274.00
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$251.00 - $274.00
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ANSI/AAMI/ISO 5361:2012

Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors
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$133.00
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$236.00
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$236.00
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ANSI/AAMI/ISO 80601-2-35:2009 (PDF)

ANSI/AAMI/ISO 80601-2-35:2009, Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
AAMI Member:
$129.00
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$229.00
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$229.00
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ANSI/AAMI/ISO 81060-1:2007/(R)2013

Non invasive sphygmomanometers - Part 1: Requirements and test methods for nonautomated measurement type.
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$126.00
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$221.00
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$221.00
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Applying Human Factors Engineering to Legacy Medical Devices

ANSI/AAMI/IEC 62366 calls for manufacturers to implement a rigorous HFE program in conjunction with developing medical devices for which they will seek regulatory approval; an approval that hinges on compliance with IEC standards. However, most legacy medical devices were not developed with a focus on HFE. Consequently, manufacturers are struggling to understand how much HFE is enough when reassessing the use-safety of legacy devices that they have little interest in modifying based on retrospective HFE analyses.
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$135.00
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$225.00
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$225.00
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Biological Evaluation of Medical Devices: Application of ANSI/AAMI/ISO 10993 Parts 1 and 17

This webinar addresses two parts of the international standard ANSI/AAMI/ISO 10993, Biological evaluation of medical devices and its application for manufacturers, researchers, laboratories, and regulators involved in development, testing, or approval of medical devices.
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$149.00
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$249.00
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$249.00
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Electrical Safety Manual - 2015 Edition

A Comprehensive Guide to Electrical Safety Standards for Healthcare Facilities
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$135.00
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$223.00
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$223.00
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Electrical Safety Manual - 2015 Edition Set

Get Print and PDF copies of A Comprehensive Guide to Electrical Safety Standards for Healthcare Facilities
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$209.00
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$350.00
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$350.00
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Endoscope Reprocessing Video

The Endoscope Reprocessing: Critical Training Steps to Promote Patient Safety video comes on a DVD. This 30-minute instructional video includes info on how endoscopes work, correct handling, guidance on reprocessing, and much more.
AAMI Member:
$132.00
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$220.00
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$220.00
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Ensuring Water and Dialysate Quality for Acute Hemodialysis

This webinar will help you understand potential risks to patient safety from water and dialysate for acute hemodialysis services provided in thousands of hospitals across the United States.
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$15.00
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$20.00
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$20.00
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eSubscription: HTM Collection

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Description Individual user access. The updated collection consisting of detailed and practical resources written by and expressly for biomedical equipment technicians, clinical engineers, and other healthcare technology professionals offers guidance on topics ranging from preparing for a Joint Commission survey to troubleshooting and maintaining equipment. Includes: ANSI/AAMI EQ56:2013, ANSI/AAMI EQ89:2015, AAMI TIR18:2010, AAMI TIR21:2017, AAMI/IEC TIR62354:2015, Electrical Safety Manual, CHTM Study Guide, and related publications and articles.
AAMI Member:
$635.00
List Price:
$885.00
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$885.00


FDA Final Guidance for Infusion Pumps: Total Product Life Cycle and Safety Assurance Cases

The FDA recently released the final guidance for Infusion Pumps Total Product Life Cycle. With the final guidance, FDA lays out further details and clarification on safety assurance cases compared to the April 2010 draft guidance.
AAMI Member:
$119.00
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$199.00
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$199.00
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Future Horizons/AAMI's 40th Anniversary Book Combo

Explore the past and future of the medical technology field with this special offer from AAMI. 40 Years of People, Progress, and Patient Safety chronicles AAMI's history, and with it the development of the field, from medical device regulation to certification and standards development. Future Horizons: The Next 40 Years in Medical Technology looks ahead with a series of articles on what's next in healthcare technology.

Together, these publications are an invaluable reference tool for students, educators, and anyone interested in the evolution of this unique field.
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$39.00
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$65.00
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$65.00
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Getting Started With Cybersecurity Risk Management (Webinar On Demand)

Using examples, this webinar will illustrates how cybersecurity risk analysis can be performed by device manufacturers in leveraging safety risk analysis practices, how the cybersecurity risk analysis results can be documented to meet the premarket submission requirements and to communicate with other stakeholders, and what special considerations should be given for cybersecurity risk management compared with safety risk management.
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$119.00
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$199.00
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$199.00
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Hemodialysis Horizons

This special magazine frames important issues affecting the hemodialysis field and that contribute to the safety of patients around the world. Articles examine: · The current status and future directions of hemodialysis machine technology · Reimbursement issues · Home hemodialysis · Preparedness after the Gulf Coast hurricane · Sodium bicarbonate mixing considerations · Neglected safety aspects in hemodialysis machines and their related problems · Developing a QC/QA program for water purification and distribution · High quality dialysate: Its Importance to the Dialysis Patient · Computers in hemodialysis facilities
AAMI Member:
$22.00
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$36.00
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$36.00
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Horizons 2010 Fall: 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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$36.00
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Horizons 2011 Spring: Improving Medical Alarm Systems

This issue focuses exclusively on improving medical device alarm systems, which warn of danger by alerting caregivers to critical medical information. Today, by and large, medical alarms don’t work well. Too many devices sound too many alarms and are wrong too often. Why is that, and what can be done about it? This special issue examines how to improve the safety and effectiveness of such systems.
AAMI Member:
$22.00
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$36.00
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$36.00
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Horizons 2012 Spring: Sterilization and Reprocessing

Spring 2012 Horizons: Sterilization and Reprocessing

There is increasing concern that inadequately reprocessed devices are responsible for a host of hospital-acquired infections. “Sterilization and Reprocessing--A Matter of Patient Safety” offers the latest practices, expert advice, and practical tips from manufacturers, regulators, clinicians, sterile processing experts, and other healthcare technology professionals.
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
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