AAMI

Association for the Advancement of Medical Instrumentation 1988 – 2024

Showing 65–80 of 342 results

AAMI 60601 1 2 2021
ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021, Medical electrical equipment—Part 1-2: General requirements for basic safety and essential…

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AAMI 60601 1 8 2021
ANSI/AAMI/ IEC 60601-1-8:2006 & A1: 2013 & A2:2021, Medical electrical equipment—Part 1-8: General requirements for…

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AAMI 2800 1 2022
ANSI/AAMI/UL 2800-1:2022, Standard for Medical Device Interoperability Published By Publication Date Number of Pages AAMI…

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AAMI 2800 1 3 2022
ANSI/AAMI/UL 2800-1-3:2022, Standard for Interoperable Item Integration Life Cycle Published By Publication Date Number of…

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AAMI 2800 1 2 2022
ANSI/AAMI/UL 2800-1-2:2022, Standard for Interoperable Item Development Life Cycle Published By Publication Date Number of…

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AAMI 2800 1 1 2022
ANSI/AAMI/UL 2800-1-1:2022, Standard for Risk Concerns for Interoperable Medical Products Published By Publication Date Number…

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AAMI TIR100 2021
AAMI TIR100:2021, End-to-end microbiological quality and sterility assurance Published By Publication Date Number of Pages…

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AAMI CR34971 2022
AAMI CR34971:2022 AAMI Consensus Report: Guidance on the Application of ISO 14971 to Artificial Intelligence…

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AAMI ST91 2021
ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities Published By Publication Date…

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AAMI TIR48 2015 RA2021
AAMI TIR48:2015/(R)2021 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP…

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AAMI TIR43 2021
AAMI TIR43:2021, Ultrapure dialysis fluid for hemodialysis and related therapies Published By Publication Date Number…

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AAMI TIR42 2021
AAMI TIR42:2021, Evaluation of particulae associated with vascular medical devices Published By Publication Date Number…

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AAMI TIR20416 2020
AAMI/ISO TIR20416:2020, Medical devices-Post-market surveillance for manufacturers Published By Publication Date Number of Pages AAMI…

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AAMI TIR12 2020
AAMI TIR12:2020, Designing, testing, and labeling medical devices intended for processing by health care facilities:…

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AAMI TIR105 2020
AAMI TIR105:2020 Risk management guidance for combination products Published By Publication Date Number of Pages…

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AAMI PC76 2021
ANSI/AAMI PC76:2021, Active implantable medical devices-Requirements and test protocols for safety of patients with pacemakers…

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