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AAMI TIR12:2020(R2023)
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Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
Hardcopy , PDF
English
07-09-2023
This document provides guidance to medical device manufacturers, who are required to provide instructions that detail the processing steps from pre-treatment at the point of use through the terminal process and storage to accompany reusable and single-use medical devices that are processed by a health care facility prior to clinical use.
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