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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.
$256.00
$451.00
$451.00

A Practicum for Healthcare Technology Management

Just revised, this textbook is the go to resource for new and seasoned biomedical professionals. It covers everything from The Joint Commission accreditation process and managing medical device safety to human factors engineering and evidence-based medical equipment maintenance management. Based on Les Atles' best-selling "A Practicum for Biomedical Engineering and Technology Management" and written by experts in the profession.
$180.00
$301.00
$301.00

A Practicum for Healthcare Technology Management (Set)

This is a set of the PDF and hard back version.
Just revised, this textbook is the go to resource for new and seasoned biomedical professionals. It covers everything from The Joint Commission accreditation process and managing medical device safety to human factors engineering and evidence-based medical equipment maintenance management. Based on Les Atles' best-selling "A Practicum for Biomedical Engineering and Technology Management" and written by experts in the profession.

To preview this file click here.
$261.00
$441.00
$441.00

AAMI HIT1000-3(PS):2019

Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
$0.00
$21.00
$21.00
Available for Immediate Download

AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
$160.00
$282.00
$282.00
Available for Immediate Download

AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
$137.00
$243.00
$243.00
Available for Immediate Download

AAMI TIR50:2014/(R)2017 (PDF)

Post-market surveillance of use error management
$114.00
$200.00
$200.00
Available for Immediate Download

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.
$119.00
$199.00
$199.00
Available for Immediate Download

AAMI TIR57:2016/(R)2019

Principles for medical device security—Risk management
$168.00
$282.00
$282.00
Available for Immediate Download

AAMI TIR63: 2014/(R)2017 (PDF)

Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
$65.00
$114.00
$114.00
Available for Immediate Download

AAMI TIR69:2017/(R)2020

Risk management of radio-frequency wireless coexistence for medical devices and systems
$137.00
$243.00
$243.00
Available for Immediate Download

AAMI TIR97:2019

Principles for medical device security—Postmarket risk management for device manufacturers
$137.00
$243.00
$243.00
Available for Immediate Download

AAMI/IEC TIR80001-2-3:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
$130.00
$228.00
$228.00

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.
$93.00
$162.00
$162.00

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
$114.00
$200.00
$200.00

AAMI/IEC TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
$74.00
$131.00
$131.00

AAMI/IEC TIR80001-2-8:2016 (PDF)

$137.00
$243.00
$243.00
Available for Immediate Download

AAMI/IEC TIR80002-1:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
$129.00
$243.00
$243.00

AAMI/ISO 13485:2016, A Practical Guide

Medical Devices—A Practical Guide, Advice from ISO/TC 210
$96.00
$134.00
$134.00
Available for Immediate Download

AAMI/ISO TIR24971:2020

Medical devices—Guidance on the application of ISO 14971
$160.00
$282.00
$282.00
Available for Immediate Download