Medical Device Testing - Sterility/Endotoxin/Bioburden

• USP <71>
• USP <161>
• ANSI/AAMI/ISO 11737-1
• ANSI/AAMI/ISO 11737-2
• AAMI TIR27
  

Whether you sterilize by steam or irradiation we can ensure your medical device is sterile and endotoxin (pyrogen) free.  We can also help you set up a qualification program to measure the bioburden. 

USP <161> states “The requirements apply to sterile and nonpyrogenic assemblies or devices in contact directly or indirectly with the cardiovascular system, the lymphatic system, or cerebrospinal fluid.”  Among those listed in the USP are sterile adhesive tape, absorbent gauze, surgical sutures for veterinary use, and other medical devices. 

For more items that may be on the list to test for sterility and/or endotoxin contact our microbiology department.