AAMI

AAMI TIR76:2021

Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
standard by Association for the Advancement of Medical Instrumentation, 03/31/2021

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AAMI CR510:2021

Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 09/24/2021

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AAMI ST44 : 2002

Resistometers used for characterizing the performance of biological and chemical indicators
standard by Association for the Advancement of Medical Instrumentation,

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AAMI TIR 101:2021

Fluid delivery performance testing for infusion pumps
standard by Association for the Advancement of Medical Instrumentation, 10/15/2021

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AAMI TIR43:2021

Ultrapure dialysis fluid for hemodialysis and related therapies
standard by Association for the Advancement of Medical Instrumentation, 02/26/2021

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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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