Which standard guides biocompatibility assessment for implanted medical devices?

• A. ISO 10993.
• B. ISO 14001.
• C. IEC 60601.
• D. ISO 13485.

Answer: (A)

Biocompatibility assessment for implanted medical devices is guided by ISO 10993. This standard provides a structured framework for evaluating how device materials interact with the human body, and it helps teams decide which biological tests are needed based on how the device will contact tissue and for how long. The testing typically covers cytotoxicity, sensitization, systemic toxicity, irritation or intracutaneous reactions, and implantation studies, along with chemical characterization when necessary, all aimed at identifying any adverse biological responses before clinical use. Other standards serve different purposes—ISO 14001 relates to environmental management; IEC 60601 focuses on electrical safety and performance of medical devices; ISO 13485 specifies quality management system requirements for manufacturers—but for the specific process of evaluating biocompatibility, ISO 10993 is the standard you’d follow.