Medical

The R&D pole dedicated to medical devices (DM) is made up of more than a dozen engineers, doctors and technicians.

We offer under ISO 13485 certification the benefits of:

• Custom Formulation (composite materials, adhesives and bio-adhesives, biocompatible coatings, wire for 3d printing, materials for spinning,…)
• Functionalization to measure
• Technical advice/support for the development of medical devices

We work in B2B collaboration on customer specifications or through national and European projects (fled, FP7, H2020,…).

Recoll offers a wide range of mechanical tests in static or fatigue (traction, compression, shear, torsion, rotation,…) on the implants of the rachis, hip, knee,… Most of these tests are accredited ISO 17025 by COFRAC.

Here is a non-exhaustive table of the standards we are testing:

The Recoll Laboratories also implement the main test methods of the standard NF en ISO 11607-1 in order to validate the performance of sterile packagings, in particular:

• Visual inspection of the seals following ATM F1886
• The tests of manual peelability and resistance of the following seals in 868-5,
• The following coloured liquid integrity tests ASTMF1929
• Vacuum or pressure integrity tests following ASTM D3078 and ASTM F2096
• The accelerated ageing tests according to ASTM F1980,
• The transport simulation tests according to the ISTA and ASTM D4169 standards (conditioning according to ASTM D4332, free fall following ASTMD5276, vibration according to ASTM D4728,…).

In addition, Recoll proposes the chemical characterization of materials according to the ISO 10993 ‐ 18 standard.

The finished, packaged and sterilized product tests proposed by Recoll following this standard include:

• The search for metallic and mineral elements by ICP-OES spectroscopy (quantitative multi-elemental analysis),
• The search for organic elements (additives, contaminants, residues of manufacture,…) by chromatography type GCMS or LC-MSMS when these additives are in the form of trace
• The search for ionic species (anions and cations) and weak acids by ionic chromatography…

These tests can be supplemented by the physico-chemical characterization of the materials:

• Thermal properties (Fusion, Crystallineness,…) of materials by Calorimetry (DSC)
• Identification of materials by spectroscopy (FTIR, UV), NMR or ICP
• Identification of impurities, residual monomers, HCT (total hydrocarbons) by chromatography (GC/MS, HPLC)
• Determination of organic carbon total COT
• Chemical properties of materials (GPC)

Recoll proposes a new test in the field of medical devices: corrosion analysis According to the ASTM F2129 standard. This test method deals with the realization of cyclic potentiodynamic polarization measurements to determine the susceptibility to corrosion of small implantable devices.

The company Recoll Manufacturing specializes in the machining of high precision technical parts (turning, milling, filming,…) through the realization of implantable DM (orthopedics, rachis, dental, Cardiac,…). For more information, we invite you to visit the website of our subsidiary Recoll Manufacturing:
https://www.rescoll-mfg.com/

We are:

• ISO 9001 and ISO 13485 certified for the design and manufacture of medical devices
• Accredited ISO 17025 by COFRAC (French Accreditation Committee) on programme No. 136 (Tests and analyses on medical devices)

Our new premises and materials are managed by a highly qualified customer service oriented staff.