Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

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]


ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS