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Evaluation of products requirements toward medical device with respective norms.
| Entry | Tasks in medical device development | Norms |
|---|---|---|
| 1 | Chemical characterization of materials, degradation products, toxico-kinetics, sample preparation, sterilization, and residues. Preclinical studies (in vitro and in vivo testing) | ISO 10993 |
| 2 | Risk assessment (identification of hazards, design and production, and clinical usage risks) | ISO 14971 |
| 3 | Clinical safety, performance, and evidence | SG5/N2R8 |
