Table of Contents
How to do Biological Evaluation (according to ISO 10993-1: 2009)
This is how biological evaluation was performed previously:
- Identify device contact nature
- Identify contact time
- Performed test as indicated in standard
How to do Biological Evaluation (according to ISO 10993-1: 2018)
This is how biological evaluation should performed to comply to the latest standard:
- Generate a Biological Evaluation Plan
- Identify the hazards, risk
- Identify the mitigation plans
- Perform material characterization
- Testing (define test sample and extraction condition) and further risk assessments
- Conclude in Biological Evaluation Report (BER) the device is safe
