As biological and tissue products and combination products become more prevalent, new questions are often asked related to microbiology that are different from those asked for traditional medical devices. As these questions become more common, additional guidance is necessary for the industry. Much of this additional guidance will be added to the new version of the ISO bioburden standard, 11737-1. Some of this information must be added due to the lack of microbiological expertise in the industry. However, when the information is added it will not be easily understandable to non-microbiologists, meaning that some understanding must be present to fully appreciate it.
Presenter: Martell Winters