Material Analysis

The quality requirements on materials for medical products are particularly high. Accordingly, it is imperative that quality is assured in the form of regular material controls. Even minimum changes to the alloy composition, an increase in oxygen concentration in the bulk, or unfavorable structure formations can seriously impair the mechanical properties or corrosion resistance of implants, for example. In a worst-case scenario, this can lead to medical damage incurred by patients.

SGS INSTITUT FRESENIUS avails of a wide range of analytical methods for supporting you when controlling your products. We offer chemical analysis, material analysis, and surface analysis from a single source. Interdisciplinary cooperation by experienced chemists, physicists and material scientists provides you with the best possible results and findings.

Information On:

  • Chemical composition of the bulk material and contamination analysis
  • Metallographic appraisal of the structure (grain size distribution, pores, phase distribution)
  • Analysis of light elements and by-elements (C, N, O, H, S)
  • Tests for determining soluble substances in plastics, e.g. plasticizers, residual monomers
  • Analysis of production-related residue: organic contamination, particles
  • Analysis of corrosion resistance
  • Media compatibility tests
  • Inspections of mechanical parameters:
    • Hardness according to Vickers
    • Component strength (< 2.5 kN)

Our Methods

  • Preparation of material samples using sections or FIB
  • Light microscopy and REM/EDX
  • Carrier gas hot extraction (TGHE) for determining lightweight elements
  • F-OES or RFA: examination of alloy components and synchronization with the database
  • ICP-OES/MS for analysis of contamination
  • XPS, ToF-SIMS for surface analyses of production-related residue or functional layers
  • Tensile and compressive strength up to 2.5 kN
  • Hardness measurements according to Vickers

Standard Excerpt

Accredited to:

DIN EN ISO 643
Steels - Micrographic determination of the apparent grain size
DIN EN ISO 1463
Metallic and oxide coatings - Measurement of coating thickness - Microscopical method
DIN EN ISO 6507-1
Metallic materials - Vickers hardness test - Part 1: Test method

Based on:

ASTM E112
Standard test methods for determining average grain size
DIN EN ISO 5832-1
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
DIN EN ISO 5832-2
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)
DIN EN ISO 5832-3
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy (ISO 5832-3:2016)
ISO 20160
Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars

Contact

SGS INSTITUT FRESENIUS GmbH
Königsbrücker Landstr. 161
01109 Dresden

t +49 351 8841-200
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