Polymer device, attributes affecting performance

ISO 10993 testing is intended to evaluate materials such as metals and polymers that essentially do not interact directly with the human immune system. However, the presence of an antibody on the device surface introduces the potential for cross-species reactions that may not be indicative of performance in humans. These interactions may affect some or all ISO 10993 in vivo tests. For example, the duration of chronic toxicity testing may be limited based on induction of immune responses or carcinogenicity studies may not be appropriate based on the specific product attributes of the antibody. 

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