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80001 TIRs - Set of 4

The set of all four TIRs to aid users in applying 80001-1, application of risk management for IT networks incorporating medical devices. This set includes 80001-2-1:2012, 80001-2-2:2012, 80001-2-3:2012, and 80001-2-4:2012.
AAMI Member:
$234.00
List Price:
$413.00
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AAMI 2016 Session: Robotic Surgery: Unique Hazards and Training Development (Webinar On Demand)

Even if you couldn't make it to AAMI 2016 in Tampa, you don't have to miss all of the great education opportunities that took place.
AAMI Member:
$39.00
List Price:
$59.00
Available for Immediate Download
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AAMI TIR57: Principles for Medical Device Security--Risk Management (Webinar On Demand)

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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$315.00
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$415.00
Available for Immediate Download
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AAMI TIR57:2016

Principles for Medical Device Security - Risk Management
AAMI Member:
$153.00
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$258.00
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AAMI TIR69:2017

Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
AAMI Member:
$125.00
List Price:
$222.00
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AAMI/IEC TIR80001-2-1:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.
AAMI Member:
$125.00
List Price:
$222.00
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AAMI/IEC TIR80001-2-2:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls.
AAMI Member:
$125.00
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$222.00
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AAMI/IEC TIR80001-2-3:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
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$118.00
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$208.00
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AAMI/IEC TIR80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations.
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$84.00
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$148.00
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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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$104.00
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$183.00
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AAMI/IEC TIR80001-2-8:2016 (PDF)

AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
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AAMI/IEC TIR80002-1:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
AAMI Member:
$117.00
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$222.00
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AAMI/ISO TIR24971:2013/(R)2016

Medical devices - Guidance on the application of ISO 14971.
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$67.00
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$119.00
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Alarms Part I: The Joint Commission’s National Patient Safety Goal on Alarm Management: How Do We Get Started? (Webinar On Demand)

Clinical alarms are a high-frequency, high-risk patient safety hazard for all hospitals. This is the first of a series of seven webinars on alarms. By the end of the series, healthcare delivery organization alarm management teams will be prepared to comply with The Joint Commission’s (TJC) new National Patient Safety Goal (NPSG) on Alarm Management. This first webinar will set the stage for the series and outline the complexity of issues related to alarm systems and the events that have led to the spotlight on alarm systems and alarm fatigue. It will cover the overall scope of TJC's NPSG, the timeline for meeting the requirements, and how the series will help the participant start to meet the NPSG.
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$0.00
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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!
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$315.00
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$415.00
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ANSI/AAMI ST91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities - What You Need to Know (Webinar On Demand)

With heightened public concern about cleanliness and decontamination, endoscopes and endoscope reprocessing are in the news seemingly every day. Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among the healthcare facilities responsible for cleaning, sterilizing, or disinfecting the devices.
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$79.00
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$99.00
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ANSI/AAMI SW87:2012

Application of Quality Management System concepts to Medical Device Data Systems (MDDS).
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$84.00
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$148.00
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ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012

MEDICAL ELECTRICAL EQUIPMENT - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
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$435.00
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$769.00
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ANSI/AAMI/IEC 62366-1:2015 (PDF)

Medical Devices Part 1: Application of Usability Engineering to Medical Devices
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$118.00
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$208.00
Available for Immediate Download
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ANSI/AAMI/IEC 80001-1:2010 (GS Kit Version)

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities, Getting Start kit version.
AAMI Member:
$40.00
List Price:
$85.00
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