Medical Device

What is the Difference Between Bioburden and Endotoxin Test?

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

Bioburden Recovery Efficiency

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

Endotoxin Test for Medical Device

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

Bacteriostasis and Fungistasis for Medical Device

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

Bioburden Test for Medical Device

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

Sterility Test for Medical Device

Sterility can be described as a condition where the presence of viable microorganisms is totally nil. A sterility test can be used to...

Ethylene Oxide Residual Analysis

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

ISO 10993-7 -Categories of Medical Devices

The ISO 10993-7 document groups medical devices into 3 major categories depending on the duration of contact with the patient. A) Limited...

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