The biomechanical testing laboratory of Cetim, a Technological Institute of Mechanics labeled Carnot, can now count on new Cofrac accreditations for its tests on implants, and thus offers manufacturers the guarantee of the high level of reliability of its results. Already accredited for testing dental and hip implants, the biomechanics laboratory is now adding several knee and spine implants. It is now the first laboratory in France to benefit from accreditations for fatigue tests on tibial bases and to benefit from a flex2 type flexible range.
In detail, the extension of the scope of accreditation of the Cetim biomechanical testing laboratory (No. 1.1006) for implant tests now includes tests according to NF ISO 7206-10, ASTM F2077, and ASTM F3292 and NF ISO 14879-1 standards on intervertebral cages, femoral heads and tibial bases (a first in France), in addition to femoral bases of hip prostheses and dental implants.
In addition to this extension, the laboratory now benefits from a flexible Flex2-type scope, which allows it, between two Cofrac evaluations, to self-accredit in its already accredited field of activity. Concretely, this recognition of its ability to master test methods and processes will allow it to adapt more quickly to the needs of tests under Cofrac accreditation. Here again, Cetim is the first biomechanics laboratory to benefit from it in France.
The scope of accreditation No. 1.1006 of the biomechanics laboratory for mechanical tests on implants, and those of the other Cofrac accreditations of cetim entities are available on www.cofrac.fr and can be consulted on www.cetim.fr.
Significant material investments
The Cetim biomechanical testing laboratory, based on its Saint-Etienne site, is a laboratory dedicated to the mechanical characterization of orthopedic implants (static, wear, fatigue, cleanliness). His team works mainly on joint prostheses (hip, knee, shoulder, ankle, wrist, elbow, spine ...) but also on other implantable medical devices (dental, vascular and trauma). Objective: to design the most biocompatible, durable and functional prosthesis possible.
For several years, Cetim has acquired new hydraulic characterization machines on orthopedic implants and has developed multi-station test benches for dedicated applications. This equipment complements other existing means of characterization, including a machine for measuring the surface topography without contact, a clean room for the cleanliness of the parts, and finally devices for characterizing the assemblies, an investment of € 2.5 million.
Support for manufacturers from the creation to the approval of the implant
Implantable medical devices stand out from other mechanical products by a very high level of requirement in terms of functional and biological biocompatibility and this, for a better osseointegration. Cetim intervenes from the creation of the device until its placing on the market, accompanying manufacturers throughout the design and approval process. Placing on the market remains long and difficult for manufacturers to obtain, hence the importance of surrounding themselves with certified partners to support them, especially since May 2021, with the entry into force of the new European Regulation 2017/745 imposing additional requirements to strengthen pre- and post-market technical files. Among them, the obligation to set up clinical evaluations and investigations to ensure their effectiveness and safety of use, the transparency of data or the strengthening of the procedures for empowering the notified bodies in charge of issuing CE marking certificates and post-marketing market surveillance.
More generally, Cetim supports medical device manufacturers since the design of new designs, the work on raw materials (study of tribological (friction), mechanical properties, corrosion, wear between components, the use of new materials such as composites), surface engineering, the study of longevity by modeling mechanical stresses, the study of new production and shaping processes (additiv manufacturing e), the development of cleaning processes compatible with sterilization requirements, the search for associated control systems such as tomography, up to the definition of test means to ensure a level of post-production quality for qualification for approval (CE marking, FDA ...). Cetim is working on multiphysical tests with the development of programmable simulators to test new designs. It also accompanies manufacturers during production monitoring, for example to improve the durability of implants and increase their performance.