Medical devices: new accreditations for RESCOLL

Accreditation for ISO 10993-12 and ISO 10993-18 standards (2020)

RESCOLL has successfully obtained the accreditation for the biocompatibility standards ISO 10993-12 and ISO 10993-18 (2020 version) related to the chemical characterization of materials used in medical devices.

These standards describe a methodology related to the extraction of materials as well as a set of analysis techniques allowing to quantify the elements released by a medical device. This essential step is the entry point for the biological risk assessment. of medical devices.

This extension of accreditation completes our analyses on medical devices according to the ISO 17025 standard for cleaning validations (ISO 19227 standard).

• HCT/COT analysis according to standards according to NF EN 1484 and NF EN ISO 9377-2
• Analysis by ICP or ion chromatography for the measurement of inorganic pollutants
• Physico-chemical characterization of raw materials

For many years, RESCOLL has been a major actor in the evaluation of medical devices thanks to its analysis service and its expertise applied to the physicochemical and morphological properties of materials, biocompatibility and cleaning validations.

RESCOLL also conducts stability studies, packaging validation and mechanical tests on materials and implants.

A large number of these tests are carried out according to the ISO 17025 standard.

Whether you need QC confirmation of raw materials, to qualify new suppliers or to verify a suspect batch, our team of chemists and polymer scientists can help you confirm the purity and composition of your raw materials. Our characterization tests on resins and elastomers include:

• Compositional analysis – Residual solvents
• Elemental Analysis / Trace Metals – Thermodynamic Properties (DSC DMA)
• Molecular weight (GPC) / crosslinking / crystallinity – Particle size characterization

Analysis of treatment baths, process and contamination expertise

The treatment baths, washing products can also be subject to monitoring or analysis:

• Determination of oxalic acid in 5% solution by ion chromatography.
• Dosing of NaOH and Na2SiO3 mixtures
• Determination of the composition of a bath of tartaric acid, nitric acid and NaF by ion chromatography
• Expertise in stains, deposits or contamination during the process

Validation of medical device packaging

RESCOLL laboratories implement the main test methods according to the ISO 11607-1 Standard in order to validate the performance of sterile packaging, in particular:

• visual inspection of seals according to ASTM F1886
• manual peelability and seal strength tests according to EN 868-5,
• Coloured liquid integrity tests according to ASTM F1929
• Integrity tests under vacuum or pressure under water according to ASTM D3078 and ASTM F2096
• Accelerated aging tests according to ASTM F1980,
• transport simulation tests according to ISTA and ASTM D4169 standards (packaging according to ASTM D4332, free fall according to ASTM D5276, vibration according to ASTM D4728, …).

Mechanical tests on implants and materials

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

For more information, please contact our sales department:

• download: rescoll-medical 2020
• or contact: commercial@rescoll.fr

dispositifs médicaux • DM