June 10, 2025 – A specialized workshop on practical requirements for biocompatibility testing in accordance with ISO 10993 was held today at Hall 35 of the Iran Health Exhibition, focusing on evaluating the biocompatibility and incompatibility of materials within the human body.

Dr. Mohammad Taghi Borjian, PhD in Biotechnology and CEO of Nikoo Pharmed Arya, explained that materials are classified as biocompatible or non-biocompatible. Biocompatible materials include bioactive and non-degradable types such as bioactive ceramics (e.g., bio-glass), calcium-phosphate ceramics for tissue engineering, bioactive polymers, coated metals like bioactive-coated metallic implants, as well as metals, polymers, and ceramics such as hydroxyapatite.

Non-biocompatible or toxic materials—often degradable and inactive—include polymers like polylactic acid (PLA) and polyglycolic acid (PGA) used in sutures and drug delivery, composites, proteins such as collagen and gelatin for uterine repair and tissue engineering, ceramics like alumina and zirconia for artificial joints and teeth, and metals like pure titanium and certain alloys with no biological response, as well as other polymers.

Highlighting the importance of ISO 10993, Dr. Borjian noted that this standard is a key requirement for medical materials testing. According to ISO 10993, biocompatibility tests are categorized into three groups: physical and chemical, in-vitro, and in-vivo.

Physical and chemical tests include assessments of strength, stability, ethylene oxide residue, and substance release. In-vitro tests cover cytotoxicity, cell adhesion, blood compatibility, genetic toxicity, and endotoxin testing. In-vivo tests evaluate irritation, sensitization, implantation, systemic toxicity, pyrogenicity, and carcinogenicity.

He concluded that the results of these tests determine whether materials are biocompatible or non-biocompatible within the body, a critical factor for the safety and proper function of medical equipment.