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AAMI/IEC TIR62366-2:2016

Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices.
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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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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
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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
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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)
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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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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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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
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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.
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Acquisition Guide for Clinical Technology Equipment

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Acquisition Guide for Clinical Technology Equipment

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ANSI/AAMI 13959:2014

Water for hemodialysis and related therapies.
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ANSI/AAMI 26722:2014

Water treatment equipment for hemodialysis and related therapies.
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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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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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ANSI/AAMI RD47:2008/(R)2013

Reprocessing of hemodialyzers.
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ANSI/AAMI ST40:2004/(R)2018 (PDF)

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
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ANSI/AAMI ST41:2008/(R)2018 (PDF)

Ethylene oxide sterilization in health care facilities: Safety and effectiveness
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ANSI/AAMI ST58:2013/(R)2018 (PDF)

Chemical sterilization and high-level disinfection in health care facilities
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ANSI/AAMI ST65:2008/(R)2018 (PDF)

Processing of reusable surgical textiles for use in health care facilities
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