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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 TIR10974:2018 (PDF)

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
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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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AAMI/ISO TIR23810:2012/(R)2015

Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup.
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AAMI/ISO TIR80002-2:2017 (PDF)

Medical device software—Part 2: Validation of software for medical device quality systems
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ANSI/AAMI 26722:2014

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

Autologous transfusion devices.
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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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ANSI/AAMI EC53:2013 (PDF)

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ANSI/AAMI HE75:2009/(R)2018 (PDF)

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ANSI/AAMI NS28:1988/(R)2015 (PDF)

Intracranial pressure monitoring devices
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ANSI/AAMI ST15883-1:2009/(R)2014 &A1:2014&A2:2012 (PDF)

(Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors—Part 1: General requirements, terms and definitions and tests
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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 ST77:2013/(R)2018 (PDF)

Containment devices for reusable medical device sterilization
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ANSI/AAMI/ IEC 60601- 2-20:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
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