The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Validating a cleaning procedure starts with selecting an appropriate artificial test soil that is representative of the worst-case challenges that are expected in clinical use for the device being evaluated[1],[2]. Various artificial test soils exist that have been developed to...
Getting a fever, is something that all of us have experienced. However, when we use medicines or medical devices, we need them to improve our health—they should not cause a fever. One of the culprits of fevers is the presence...
Simulated use is defined as “use that mimics the intended use of the medical device”[1]. In guidance documents such as the AAMI TIR12:2020[2] or AAMI TIR30:2011[3] simulated use testing often refers to test soil selection, specifying that “the test soil...
Instructions for use (IFU) documents can come in many different shapes and sizes and looking at these documents, the term “pre-cleaning” may pop up several times at different stages of the reprocessing instructions. Instructions are sometimes termed pre-cleaning when explaining...
ISO17664:2017[1] states that, where applicable, the following information with regards to the cleaning agent(s) should be included in the IFU; the “identification and concentration of chemicals required” and the “contact time of any cleaning agent used.” It also states that...
