Standard: ISO 11737-2 – “Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process”
Method: Direct immersion – method of choice for medical devices because the device is in direct contact with test media throughout the incubation period.
Requirements:
- Test method validation (Bacteriostasis and Fungistasis) shell be performed for each medical device or product family
- For validation purpose 6 sterile devices
- For routine analysis sterile medical devices [exp. 10 devices]
- Testing of nonsterile medical devices on demand
