ERA conducts all the tests required by EU product legislation for the manufacturers with its partner;

• Biomechanical tests of orthopedic implants (static strength, compression-pull, fatigue, torsion and abrasion tests).
• Biocompatibility tests (in-vitro cytotoxicity, genotoxicity, blood compatibility, irritation, sensitization, acute systemic toxicity, subchronic toxicity tests according to ISO 10993 series standards).
• Validation tests (ISO 11607-2 packaging validation, ISO 14644 series clean room validation, etc).
• Biological and bench tests (ISO 11737-x bioburden and sterility tests, performance tests conducted according to the medical device standards).
• Electrical safety and electromagnetic compatibility tests for active medical devices (EN 60601-1 and EN 61010-1 general electrical safety tests, EN 61010-1 general electrical safety tests, EN 60601-1-2 and EN 61326 electromagnetic compatibility, EN 60601-2 series special medical devices safety tests, etc).