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AAMI/IEC TIR62366-2:2016

Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices.
$160.00
$282.00
$282.00

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 TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
$160.00
$282.00
$282.00

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 TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
$160.00
$282.00
$282.00
Available for Immediate Download

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
$137.00
$243.00
$243.00
Available for Immediate Download

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'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

Acquisition Guide for Clinical Technology Equipment

$64.00
$99.00
$99.00

Acquisition Guide for Clinical Technology Equipment

$64.00
$99.00
$99.00
Available for Immediate Download

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
$114.00
$200.00
$200.00
Available for Immediate Download

ANSI/AAMI RD47:2020

Reprocessing of hemodialyzers
$137.00
$243.00
$243.00
Available for Immediate Download

ANSI/AAMI ST40:2004/(R)2018 (PDF)

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
$130.00
$228.00
$228.00
Available for Immediate Download

ANSI/AAMI ST41:2008/(R)2018 (PDF)

Ethylene oxide sterilization in health care facilities: Safety and effectiveness
$169.00
$298.00
$298.00
Available for Immediate Download

ANSI/AAMI ST58:2013/(R)2018 (PDF)

Chemical sterilization and high-level disinfection in health care facilities
$160.00
$282.00
$282.00
Available for Immediate Download

ANSI/AAMI ST65:2008/(R)2018 (PDF)

Processing of reusable surgical textiles for use in health care facilities
$137.00
$243.00
$243.00
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 ST79:2017

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
$357.00
$408.00
$408.00
Available for Immediate Download