AAMI

AAMI TIR42:2021

Evaluation of particulate associated with vascular medical devices
standard by Association for the Advancement of Medical Instrumentation, 03/31/2021

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AAMI TIR12:2020

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 09/17/2020

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Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical Devices

Book by Association for the Advancement of Medical Instrumentation, 2021

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AAMI PC76:2021

Active implantable medical devices – Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
standard by Association for the Advancement of Medical Instrumentation, 04/01/2021

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AAMI TIR105:2020

Risk management guidance for combination products
standard by Association for the Advancement of Medical Instrumentation, 09/10/2020

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AAMI HIT1000-4 (PS):2020

Safety and effectiveness of health IT software and systems – Part 4: Application of human factors engineering
standard by Association for the Advancement of Medical Instrumentation, 07/07/2020

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AAMI MP80601-2-49:2020

Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
standard by Association for the Advancement of Medical Instrumentation, 03/24/2020

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AAMI RT3: 2020

Radiation therapy machine characterization
standard by Association for the Advancement of Medical Instrumentation, 02/21/2020

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AAMI ST67:2019

Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
standard by Association for the Advancement of Medical Instrumentation, 07/29/2019

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AAMI RD47:2020

Reprocessing of hemodialyzers
standard by Association for the Advancement of Medical Instrumentation, 01/23/2020

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