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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

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 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 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 TIR24971:2020

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

AAMI/ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
$111.00
$194.00
$194.00
Available for Immediate Download

AAMI's Acquistion Guide for Clinical Technology Equipment

In the not-so-distant past, acquisition of clinical technology equipment largely meant acquiring stand-alone medical devices. For healthcare organizations, acquisition decisions and processes rested with a limited group of participants, and the processes they used varied widely across healthcare organizations. Acquisition of today's clinical technology equipment should be different. We have a better understanding of how systems interact within a larger, diverse ecosystem of people, practices, environments, and organizations. Acquisition strategies and processes should take all of this into account, lowering the risks attendant to these investments while helping organizations provide the best possible care. Objectives: In this webinar, we will review the end-to-end acquisition process and identify resources available to HTM and other healthcare professionals that will enhance their ability to support their organization's acquisition process in a more strategic and effective manner. Finally, we will highlight where and how HTM professionals can make the most impact in their organization's acquisition process. Audience: The webinar should be immediately applicable to HTM supervisors, managers, directors, and other management roles. Staff (individual contributors) may also find this session helpful in becoming stronger contributors to the HTM department's success. Those individuals seeking to advance into management roles will find the session useful in developing perspective and skills that will support career growth.
$0.00
$25.00
$25.00
Available for Immediate Download

ANSI/AAMI ST67:2019

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
$74.00
$131.00
$131.00
Available for Immediate Download

ANSI/AAMI ST91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities - What You Need to Know

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.
$20.00
$35.00
$35.00
Available for Immediate Download

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.
$476.00
$840.00
$840.00
Available for Immediate Download

ANSI/AAMI/IEC 62366-1:2015 (PDF)

Medical Devices Part 1: Application of Usability Engineering to Medical Devices
$130.00
$228.00
$228.00
Available for Immediate Download

ANSI/AAMI/IEC 80001-1 • Successfully Launching an 80001-1-Based Program

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network. This approach not only identifies the activities necessary to maintain key properties of the network (safety, effectiveness, and security), it also identifies the roles that are needed and the collaboration necessary between a healthcare delivery organization and its networked technology suppliers.
$0.00
$85.00
$85.00
Available for Immediate Download