Biocompatibility Testing for Medical Devices (ISO 10993)

TÜV SÜD is globally recognized for its quality and safety as a comprehensive third-party testing provider. We provide a vast range of medical device testing solutions required to test for biocompatibility of medical devices. With extensive experience with all types of medical devices and market requirements, we help manufacturers and suppliers independently meet global regulatory standards.

We offer a complete biocompatibility testing for medical devices through our state-of-the-art laboratories. Our high standards of data and quality reporting address the testing needs of small and large-scale manufacturers. We minimize your time-to-market.

Our experts are recognized as authorities in their fields. They possess the technical, clinical and regulatory expertise required to thoroughly evaluate biocompatibility of medical devices to ensure the devices’ suitability across global markets. Their collective expertise makes TÜV SÜD a trusted partner of choice for companies of all sizes, from Small and Medium Enterprises (SMEs) to Multinational Companies (MNCs). We meet your project timelines with predictability and diligence. 

TÜV SÜD provides the following biocompatibility tests to help manufacturers meet biocompatibility testing requirements of the International Organisation for Standardisation (ISO), and American Society for Testing and Materials (ASTM). 

• Cytotoxicity: ISO 10993-5 – Cytotoxicity tests are conducted to evaluate the general toxicity level of the medical device or material on cell culture through in vitro elution and agarose overlay methods. 
• Genotoxicity: ISO 10993-3 – Genotoxicity tests are required to identify the presence of toxins that can impact the genetic material of cells. Following the ISO requirements, we examine: 
  • Gene mutation through the bacterial mutagenicity test/bacterial reverse mutation assay 
  • Chromosomal damages via in vitro chromosomal aberration assay through mouse lymphoma assay
  • DNA damage through in vitro chromosomal aberrations assay and in vitro/in vivo erythrocyte micronucleus test 
• Hemocompatibility: ISO 10993-4 & ASTM – Hemocompatibility tests help evaluate the effects of blood-contacting medical devices on blood and blood components. These include hematology and thrombosis tests. 
• Irritation: ISO 10993-10 – Irritation testing assesses the medical device for skin irritability through primary skin, ocular and intracutaneous reactivity tests and in vitro skin irritation tests. 
• Sensitisation: ISO 10993-10 – Sensitisation tests are conducted to evaluate possible adverse cutaneous reactions of the immune system to the medical device through and in vitro testing methods. 
• Systemic Effects of Systemic Toxicity and Pyrogenicity: ISO 10993-11 and ASTM – Acute to chronic systemic toxicity tests assess effects of medical devices in vivo. Pyrogenicity tests are carried out to test for material-mediated fever-causing compounds called pyrogens that impact patients when they come in contact with the medical device. 
• Implantation: ISO 10993-6 – Implantation tests evaluate the effects of medical devices on the surrounding living tissue at both macroscopic and microscopic levels. 
• Chemical Characterisation: ISO 10993-18 – Chemical characterisation is required to identify the quantities of extractables and leachables that migrate from a medical device when it is used or challenged. 
• Toxicological Risk Assessment: ISO 10993-17 – A toxicological risk assessment of extractables and leachables helps quantify associated risks based on exposure and safe intake. 
• Sterility Testing: ISO 11737 series – Bioburden testing, as part of sterility testing, helps to determine the population of microorganisms on a medical device that has not been sterilised. 
• Sterile Barrier System: ISO 11607 & EN 868 series – Sterile barrier tests are required for the validation of a medical device’s packaging system to ensure the device maintains its sterility and aseptic quality before use. 
• Transporation studies
• Aging studies