AAMI TIR12:2020Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturersstandard by Association for the Advancement of Medical Instrumentation, 09/17/2020
AAMI TIR105:2020Risk management guidance for combination productsstandard by Association for the Advancement of Medical Instrumentation, 09/10/2020
Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical DevicesBook by Association for the Advancement of Medical Instrumentation, 2021
AAMI HIT1000-4 (PS):2020Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineeringstandard by Association for the Advancement of Medical Instrumentation, 07/07/2020
AAMI MP80601-2-49:2020Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitorsstandard by Association for the Advancement of Medical Instrumentation, 03/24/2020
AAMI RT3: 2020Radiation therapy machine characterizationstandard by Association for the Advancement of Medical Instrumentation, 02/21/2020
AAMI RD47:2020Reprocessing of hemodialyzersstandard by Association for the Advancement of Medical Instrumentation, 01/23/2020
AAMI CR500:2019Basic Introduction to the IEC 60601 Seriesstandard by Association for the Advancement of Medical Instrumentation, 12/18/2019
AAMI ST72:2019Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)standard by Association for the Advancement of Medical Instrumentation, 11/01/2019
AAMI TIR102:2019U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systemsstandard by Association for the Advancement of Medical Instrumentation, 08/30/2019
AAMI TIR97:2019Principles for medical device security - Postmarket risk management for device manufacturersstandard by Association for the Advancement of Medical Instrumentation, 09/27/2019
AAMI ST67:2019Sterilization 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