EN ISO 13485 certified

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Marle Orthopaedics Manufacturing

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  5. Testing equipment
Medical risk management

Testing tools and facilities to guarantee quality and safety

Marle plants integrate a comprehensive set of testing tools that is constantly updated and renewed, to guarantee the higher quality achievable.

Implant inspection in Marle's laboratoriesLaboratory analyses

Our laboratory is equipped with the apparatus suitable for performing various metallographic inspections on orthopaedic implants and instrumentation such as examinations and expert evaluations.

Laboratory analyses

  • Grain size (per ASTM E112, E930, E1181, NF EN ISO 643)
  • Inclusion content (ASTM E45 and ISO 4967)
  • Delta Ferrite content (AMS 2315 and ASTM E562)
  • Titanium alloy structures (NF ISO 20160 and ETTC2)
  • Depth of Alpha-Case layer and contaminated layers (P3TF19 and NF EN 2003-009)
  • Control of flow lines (ASTM E340).

We ensure that test samples are prepared in line with recognized standardized (ASTM E3) methods and machine them on our CNC machines.
Our mechanical testing apparatus is also used for material characterization:

  • Tensile mechanical properties for metallic alloys up to 50 kN (ISO 6892-1 and ASTM E8/E8M)
  • Hardness of metallic alloys: HRC, HV30, HBW2,5/187,5 (NF EN ISO 6508-1, 6507-1, 6506-1, ASTM E18, E92, E10)
  • Micro hardness of metallic alloys: HV0, 2 (NF EN ISO 6507-1 and ASTM E384)
  • Determination of adhesion resistance of hydroxyapatite coatings
  • Determination of porosity rate and thickness of hydroxyapatite coatings

All tests above are accredited in accordance with ISO 17025 by COFRAC.

ilac mra logo

ACCREDITATION N° 1-2417

Scope available on www.cofrac.fr

COFRAC is signatory of the international recognition agreements ILAC (International Laboratory Accreditation) and IAF (International Accreditation Forum) through EA (European cooperation for Accreditation) for the concerned tests.

Metallurgic analysis (corrosion, fracture surface, various defects...) realized excluding accreditation.

Laboratory Materials of ATS

  • Tensile mechanical properties for Nitrogen stainless steel and Cobalt-Chrome-Molybdenum alloy up to 50kN (ISO 6892-1 and ASTM E8/E8M)
  • Hardness of Nitrogen stainless steel: HRC (NF EN ISO 6508-1, ASTM E18) and Cobalt-Chrome-Molybdenum alloy HBW2,5/187,5 (NF EN ISO 6506-1, E10).

All tests above are accredited in accordance with ISO 17025 by COFRAC.

ilac mra logo

ACCREDITATION N° 1-6518

Scope available on www.cofrac.fr

COFRAC is signatory of the international recognition agreements ILAC (International Laboratory Accreditation) and IAF (International Accreditation Forum) through EA (European cooperation for Accreditation) for the concerned tests.

Metallurgical analysis (grain size, inclusion rating, corrosion, fracture surface, various defects…) realized excluding accreditation.

Dimensional inspection

At each stage of production our Quality Control Department checks and validates product dimensions in accordance with drawing requirements and carries out statistical analyses in line with your specifications (product capability, process).

  • Profile projectors with calculator (evaluation of freeform contours, teeth tracking, dimensional measurements)
  • Automated air gage for taper inspection
  • 3D (CMM) measuring machines (automatic scanning and probing, CAD programme comparison, mapping of freeform surfaces)

 

 

  • Quality
  • Testing equipment
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BSI Assurance Mark ISO 13485MD 559928

News

  • Marle at the Elysée to present its Made in France product

    Elysee Palace Our site Etablissements Maurice Marle in Nogent (52800) was selected from 1750 candidates to represent the department of Haute-Marne, during the Great Exhibition of Made in France. >>

  • Marle to exhibit for the first time in China!

    COA 2019 logo Marle Group to exhibit for the first time in China, for the 14th Annual Congress of Chinese Orthopaedic Association, in Shanghai, from 15th to 17th November 2019. >>

  • A new shareholder to accompany Marle Group development

    Logo Dentressangle DENTRESSANGLE, the family-investment holding company, has entered into exclusive negotiations to acquire a majority stake in MARLE. >>

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