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Ethylene oxide gas (EO) is a flammable and colorless gas commonly used in medical device sterilization. Its permitted maximum residual levels are set by a range of international and local organizations, including the International Organization for Standardization (i.e., ISO 10993-7:2008) and Japanese Industrial Standards (i.e., JIS T 0993-7:2012). 1.Biological Effect: Physical and/or Chemical information […]

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Building a Pre-clinical Study Report for Biocompatibility Testing

The “Big Three” in Biocompatibility: Key Tests for Medical Devices

Cytotoxicity Testing via MEM Elution: Ensuring Medical Device Biocompatibility

AMES Bacterial Reverse Mutation Test and its Role in Biocompatibility Evaluation

Testing Methods: A Comprehensive Look at In Vitro and In Vivo Approaches

The Significance of Biological Risk Assessment (BRA) in Biocompatibility Testing

Understanding MTT in Cytotoxicity Testing for Biocompatibility Assessment of Medical Devices

What GLP Certification means in Medical Device Testing

The Crucial Role of Biological Evaluation Plan (BEP) in Biocompatibility Testing

Ensuring Your Medical Device Meets the Highest Standards: Why and When to Test

Navigating the Path to Success: Selecting the Right Medical Device Testing Laboratory

EO & ECH Residual Test

Hemocompatibilty