1. Turnaround time: to be determined upon study parameters
2. Sample Requirements: at least 3 samples (non-sterile)
ISO 11737-1 & USP <61>
The scope of the study included determining the bioburden of the test article according to ISO 11737-1:2018 Sterilization of healthcare products – Microbiological methods – Part 1: Determination of a population of microorganisms on products. The aim of the study is to determine the bioburden of the medical device.
Bioburden of test items is assessed by removing microorganisms from test item surface followed by their culturing and enumeration.