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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
This technical information report (TIR) 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. In addition, greater detail is provided about the processes and resources that a health care facility can have for processing devices. This should provide further assistance to medical device manufacturers (MDMs) in developing their processing instructions.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
