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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
$137.00
$243.00
$243.00

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
$137.00
$243.00
$243.00
Available for Immediate Download

ANSI/AAMI/ISO 25539-3:2011/(R)2015

Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters.
$160.00
$282.00
$282.00
Available for Immediate Download

ANSI/AAMI/ISO 81060-1:2007/(R)2013

Non invasive sphygmomanometers - Part 1: Requirements and test methods for nonautomated measurement type.
$130.00
$228.00
$228.00

ANSI/AAMI/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
$247.00
$414.00
$414.00
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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.
$135.00
$225.00
$225.00
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Electrical Safety Manual - 2015 Edition

A Comprehensive Guide to Electrical Safety Standards for Healthcare Facilities
$139.00
$230.00
$230.00
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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
$215.00
$361.00
$361.00

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.
$136.00
$227.00
$227.00

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.
$15.00
$20.00
$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.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$635.00
List Price:
$885.00
Your Price:
$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.
$119.00
$199.00
$199.00
Available for Immediate Download

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.
$119.00
$199.00
$199.00
Available for Immediate Download

HTMLIVE! Webinar: Using HTM Data to Drive High Reliability Healthcare

In this special HTM Week Webinar, HTM representatives from the Department of Veterans Affairs (VA) will present approaches to reduce variability of data and business processes across 170 medical centers. VA will share how it’s using data to improve patient safety, monitor/benchmark program performance, strategically plan for new medical technology, and manage medical equipment cybersecurity. VA will preview a works-in-progress model to project HTM resource/staffing needs.
$0.00
$25.00
$25.00
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HTMLIVE! Webinar: Your AEM Program: Patient Safety, Standards Compliance, and Less PM

An AEM program, done well, can save a lot of PM time (and time equals money). However, compliance with CMS and Joint Commission requirements can be intimidating. In this webinar, we'll look at what's really required and how to put together a safe and effective AEM program.
$0.00
$25.00
$25.00
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Industrial Sterilization: Research from the Field

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance.
$70.00
$116.00
$116.00

Industrial Sterilization: Research from the Field (PDF)

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance. PDF format.
$70.00
$116.00
$116.00
Available for Immediate Download

Introduction to Updated IEC 62366 - Parts 1 & 2

In 2015, the International Electrotechnical Commission (IEC) is expected to release an updated version of IEC 62366:2007, Medical devices -- Application of usability engineering to medical devices. The updated version will have two parts. Part 1 will focus on medical device’s use-safety, describing usability engineering (aka human factors engineering) activities and end-products that will be the basis of future compliance assessments. Part 2 will have more of a tutorial nature, complementing Part 1 by describing best practices in the usability engineering of medical devices.
$135.00
$225.00
$225.00
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Machine Learning AI in Medical Devices

Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance
$0.00
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$0.00
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Medical Device Risk Management and Safety Assurance Cases

The FDA recently reported that class I recalls have increased from an average of 25 per year before 2008 to 50 in 2011 and 57 in 2012 (1). A class I recall is a situation in which there is a reasonable probability that use, or exposure to, a medical device will cause serious adverse health consequences or death. As the complexity and sophistication of medical technology and health care infrastructure continue to increase, assuring proper identification and adequate risk controls of these potential recall situations (i.e. hazardous situations) prior to the device being placed on the market is becoming more and more critical and challenging. How effective are the existing medical device risk management practices in assuring proper identification and controls of risks? Are there any gaps and opportunities? How can these gaps be addressed? What is FDA’s view on this issue?
$119.00
$199.00
$199.00
Available for Immediate Download