Historical

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]

Others Also Bought
A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devi ...
Comprehensive guide to steam sterilization and sterility assurance in health care facilities (contains amendme ...
Cleaning validation of health care products - Requirements for development and validation of a cleaning process ...
Included in Packages
This standard is not included in any packages.
Document History
Amendments & Corrections
We have no amendments or corrections for this standard.