The biomechanical testing laboratory at Cetim, the Carnot-accredited Institut technologique de mécanique, can now count on new Cofrac accreditations for its implant testing, offering manufacturers a guarantee of the high level of reliability of its results. Already accredited for testing dental and hip implants, the biomechanics laboratory has now added several knee and spine implants to its list of accreditations. It is now the first laboratory in France to be accredited for fatigue testing on tibial bases, and to benefit from a flexible Flex2-type scope.
In detail, the extension of Cetim's biomechanical testing laboratory's scope of accreditation (N°1.1006) for implant testing now includes testing to standards NF ISO 7206-10, ASTM F2077, and ASTM F3292 and NF ISO 14879-1 on intervertebral cages, femoral heads and tibial bases (a first in France), in addition to femoral bases for hip prostheses and dental implants.
In addition to this extension, the laboratory now benefits from a flexible Flex2 scope, which authorizes it, between two Cofrac assessments, to self-accredit within its already accredited field of activity. In concrete terms, this recognition of its ability to master testing methods and processes will enable it to adapt more rapidly to the needs of Cofrac-accredited testing. Once again, Cetim is the first biomechanics laboratory in France to benefit from this accreditation.
The scope of accreditation N° 1.1006 of the biomechanics laboratory for mechanical tests on implants, and those of the other Cofrac accreditations of Cetim's entities are available on www.cofrac.fr and can be consulted on www.cetim.fr.
Major investments in equipment
Cetim's biomechanical testing laboratory, based at its Saint-Etienne site, is dedicated to the mechanical characterization of orthopedic implants (statics, wear, fatigue, cleanliness). Its team works mainly on joint prostheses (hip, knee, shoulder, ankle, wrist, elbow, spine...) but also on other implantable medical devices (dental, vascular and trauma). The aim is to design the most biocompatible, durable and functional prosthesis possible.
Several years ago, Cetim acquired new hydraulic characterization machines for orthopedic implants, and developed multi-station test benches for dedicated applications. This equipment complements other existing characterization resources, notably a machine for non-contact surface topography measurement, a clean room for part cleanliness, and assembly characterization devices, representing an investment of €2.5m.
Support for manufacturers from design to implant approval
Implantable medical devices differ from other mechanical products in that their functional and biological biocompatibility must meet the highest standards, in order to ensure better osseointegration. Cetim is involved from the creation of the device right through to market launch, supporting manufacturers throughout the design and approval process. Marketing remains a long and difficult process for manufacturers, hence the importance of surrounding themselves with certified partners to support them, all the more so 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 dossiers. Among them, the obligation to set up clinical evaluations and investigations to ensure their efficacy and safety of use, data transparency or even the strengthening of accreditation procedures for notified bodies in charge of issuing CE marking certificates and post-market surveillance.
More generally, Cetim supports medical device manufacturers from the conception of new designs, work on raw materials (study of tribological properties (friction), mechanical properties, corrosion, wear between components, use of new materials such as composites), surface engineering, study of longevity by modeling mechanical constraints, the study of new production and shaping processes (additive manufacturing), the development of cleaning processes compatible with sterilization requirements, research into associated control systems such as tomography, right through to the definition of testing resources to ensure a level of post-production quality for qualification with a view to homologation (CE marking, FDA, etc.).). In particular, Cetim works on multiphysics testing, developing programmable simulators to test new designs. It also supports manufacturers during production monitoring, for example to improve the durability of implants and enhance their performance.
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