Manual Cleaning Validation
1. Turnaround time: to be determined upon study parameters
2. Sample Requirements: at least 5 samples
AAMI TIR12 & ANSI/AAMI ST98 (AAMI TIR30)
& ISO 15883 & ISO 17664 & ASTM 2314 & FDA guidance
Cleaning validation services are used to validate manufacturer’s IFU (instructions for use). This includes soiling, cleaning, and post-processing effectiveness testing. A successful validation is required to assure a device can be properly cleaned after clinical use. Methodology involves soiling the medical device with an appropriate test soil and cleaning the device according to the manufacturer’s IFU. The total surface area of medical devices required for end-point calculations. Visual inspection of medical devices is performed and exhaustive recovery of residual soil components. Residual analysis can include protein contamination or total organic carbon contamination (TOC) or endotoxin to quantitatively determine.