The Bacteriostasis and Fungistasis (B&F) test is also known as the Sterility Suitability test. The test is performed on a sterile...

What is Sterile? According to ISO11737-1 , an item or product is considered sterile when it is free from viable microorganisms. Viable...

The safety and effectiveness of medical devices are non-negotiable in the healthcare industry. Sterilization validation stands as a...

ISO 10993 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the biological...

ISO 11137 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the...

ISO 11135:2014 is an international standard that provides guidelines for the sterilization of medical devices using ethylene oxide (EtO)....

What is Bioburden Testing? Bioburden is the population of viable microorganisms in or on a product, water, or raw material. Bioburden...

What is Bioburden? Bioburden is the population of viable microorganisms present on or in a product. The bioburden of a product can come...

What is endotoxin? Endotoxin is a type of toxin that is produced by gram-negative bacteria. It can also be introduced into the body...

What Is Bioburden Testing Bioburden is the population of viable microorganisms in or on a product, water, or raw material. Bioburden test...

Ethylene Oxide Sterilization For Medical Device Ethylene Oxide (EO or EtO) is used to sterilize medical devices. Ethylene oxide gas...

ISO 10993-7 is a standard developed by the International Organization for Standardization (ISO) that outlines the requirements for...