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

$137.00
$243.00
$243.00
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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
$129.00
$243.00
$243.00

AAMI/IEC TIR80002-3:2016

Technical Information Report Medical Device Software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
$114.00
$200.00
$200.00

AAMI/ISO 13485:2016, A Practical Guide

Medical Devices—A Practical Guide, Advice from ISO/TC 210
$96.00
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$134.00
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AAMI/ISO TIR10974:2018 (PDF)

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
$171.00
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$302.00
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AAMI/ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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$282.00
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AAMI/ISO TIR17665-2:2009/(R)2016 (PDF)

Sterilization of health care products - Moist Heat - Part 2: Guidance on the application of AAMI/ISO 17665-1
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$243.00
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AAMI/ISO TIR17665-3:2014/(R)2016

Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization
$137.00
$243.00
$243.00

AAMI/ISO TIR22442-4:2011/(R)2016

Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes.
$93.00
$162.00
$162.00

AAMI/ISO TIR23810:2012/(R)2015

Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup.
$114.00
$200.00
$200.00

AAMI/ISO TIR24971:2020

Medical devices—Guidance on the application of ISO 14971
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$282.00
$282.00
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AAMI/ISO TIR80002-2:2017 (PDF)

Medical device software—Part 2: Validation of software for medical device quality systems
$160.00
$282.00
$282.00
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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
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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.
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$25.00
$25.00
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Acquisition Guide for Clinical Technology Equipment

$64.00
$99.00
$99.00

Acquisition Guide for Clinical Technology Equipment

$64.00
$99.00
$99.00
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ANSI/AAMI 2700-1:2019

Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
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$200.00
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ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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$282.00
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ANSI/AAMI EC53:2013 (PDF)

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$131.00
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ANSI/AAMI EQ93:2019

Medical equipment management—Vocabulary used in medical equipment programs
$65.00
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$114.00
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