Microbial and chemical testing of medical devices
1. Testing Object:
Medical Devices
2. Testing Items:
1. Microbial enumeration tests 2. Bioburden 3. Total bacterial colonies
4. Total fungal colonies5. Sterility Test 6. Bacterial Endotoxin Test
7. Ethylene Oxide Residuals 8. Ethylene chlorohydrin residuals 9. Particles
10. Biological Monitoring of Ethylene Oxide Sterilization
11. Spore count of biological indicators

Testing standards and regulations:
Microbiological and chemical testing of medical devices

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