Which standard provides guidance specifically on biocompatibility for materials used in medical devices?

The standard that provides guidance specifically on biocompatibility for materials used in medical devices is ISO 10993. This standard outlines the evaluation and testing of the biocompatibility of medical device materials to ensure they do not cause adverse biological reactions when in contact with the body. It includes a series of tests that assess different aspects of biocompatibility, such as cytotoxicity, irritation, and sensitization, facilitating regulatory compliance and safety assessments for medical devices.

ISO 14155 pertains to the good clinical practice for clinical investigations of medical devices, focusing on how research should be conducted ethically and scientifically rather than on material biocompatibility. ISO 13485 covers quality management systems for medical devices, ensuring organizations maintain the necessary processes for the design, production, and servicing of medical devices but does not specifically address material biocompatibility. ISO 980 relates to the classification of medical devices but is not focused on biocompatibility. Thus, ISO 10993 is the appropriate standard for addressing the biocompatibility of materials used in medical devices.