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 test determines the number of these microorganisms present, reported as colony forming units (CFU). The test usually involves an extraction step to remove the microorganisms followed by an enumeration or culturing technique to quantify the extracted organisms. Click here to learn more on Bioburden Testing. What is Bacterial Endotoxin Test? B

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...

ISO 17025:2017 requires that a decision rule should be applied to any statement of conformity to a specification or standard in a 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...