| Type of test | Testing Body | RESULT |
| Toxicological tests | ||
| Product biological assessment | Head Testing Centre of Hygiene Research Institute, Novosibirsk |
Ceramic components are non-toxic, sterile, pyrogen-free, hemolytically neutral, and have no skin irritating effect. No sensitizing effect was found Meet all the requirements for medical devices |
| Characteristics determination of material degradation | Head Testing Centre of Hygiene Research Institute, Novosibirsk | Samples after testing do not show degradation traces |
| Toxicological tests of medical product | Head Testing Centre of Hygiene Research Institute, Novosibirsk |
Meet all the requirements for medical devices |
| Toxicological tests of medical product |
Laboratory of Cancer Research Center for Quality Control, Moscow |
According to sanitary, chemical, cytotactic, irritant, toxic, genotoxic indicators, and the results of the implant test, product meet the requirements for medical devices. Confirmed sterility of the product |
| Toxicological tests of medical product | Medical Technology Research and Testing Institute of Federal Service for Surveillance in Healthcare, Moscow | Comply with safety requirements |
| Technical tests | ||
| Friction pair durability tests | National Medical Research Center of Traumatology and Orthopedics N.N.Priorova, Moscow | The durability of the product has been confirmed for at least 10 years |
| Strength characteristics | Zimmer Biomet UK, Swindonm | No signs of wear Samples tested exceeded the minimum requirements for ceramic hip heads |
| Torque determination of friction pair with polyethylene lining | CITOproject, Moscow | The test results confirm the stated durability of the product. There are no signs of wear |
| Femoral head determination wear and tear for a full torque testing cycle of a friction pair with lining | CITOproject, Moscow | The test results confirm the stated durability of the product. There are no signs of wear |
| Compliance testing | Testing Center «Medi-Technological Agency», Moscow | The medical device fully compliant with regulations |
| Static compression tests | Testing laboratory of the Research Center, Novosibirsk Akademcity | The maximum load values exceed the established requirements |
| Clinical tests | ||
| Clinical tests | Novosibirsk Research Institute of Traumatology and Orthopedics Y.L. Tsivyan | Fully complies with all regulatory, technical and operational requirements announced by manufacturer for intended purpose and usage, quality, effectiveness and safety to use in clinical practice |
| Clinical tests | National Medical Research Center of Traumatology and Orthopedics N.N.Priorova, Moscow | Complies with all regulatory, technical and operational requirements and can be recommended for registration and subsequent use in medical institutions |
