Biokompatibility (ISO 10993)

In RMS Foundation we can offer you the following services in the area of biocompatibilty testing:

Leachables & Extractables (ISO 10993)

Description: Inorganic and organic leachables and extractables of medical devices or their components are quantified by inductively coupled plasma mass spectrometry (ICP-MS) or gas chromatography coupled with mass spectrometry (GC-MS) after extraction in a temperature-controlled incubation shaker according to ISO 10993.
Standard(s):
  • ISO 10993
  • ICH Q3D (R2)
Newsletter:
  • Cleanliness of medical devices (NL-16)
  • Fourier transform infrared microscopy (FTIR microscopy) (NL-21)
  • ISO 10993: Biological Evaluation of Medical Devices (NL-25)
  • Chemical analysis by ICP-MS (inductively coupled plasma mass spectrometry) (NL-27)
  • Testing of technical cleanliness according to VDA 19 Part 1 (NL-28)
  • Determination of the cleanliness of medical devices (NL-31)
  • Particle analysis: How to characterise particles generated under dynamic loading of medical devices (NL-34)
  • TOC/TIC/TN: Quantitative analysis of dissolved organic and/or inorganic carbon as well as nitrogen (NL-36)
Equipment: ICP-MS, GC-MS, TOC, TIC, TN, FT-IR, SEM/EDX

 

 

Validation of the reprocessing of medical devices

Description: Reprocessing of reusable medical devices means in particular cleaning, disinfection, functional testing, packaging, sterilization and storage. The effectiveness of the manufacturer's reprocessing instructions is tested in a worst-case scenario using the TOC/TN test to quantify residual proteins. If necessary, the appropriate number of reprocessing cycles over the lifetime of a medical device can be determined.
Standard(s):  
Newsletter:
  • Cleanliness of medical devices (NL-16)
  • ISO 10993: Biological Evaluation of Medical Devices (NL-25)
  • Testing of technical cleanliness according to VDA 19 Part 1 (NL-28)
  • Determination of the cleanliness of medical devices (NL-31)
  • Particle analysis: How to characterise particles generated under dynamic loading of medical devices (NL-34)
  • TOC/TIC/TN: Quantitative analysis of dissolved organic and/or inorganic carbon as well as nitrogen (NL-36)
Equipment:

 

 

Washing, sterilization and cleaning test for medical devices

Description: Verification and validation of the use requirements of medical devices with regard to washing, sterilization, cleaning, handling and aging. Investigation of parameters such as residual dirt levels, material aging, susceptibility to stress cracking, corrosion or functionality according to standard methods or customer requirements.
Standard(s):  
Newsletter:
  • Cleanliness of medical devices (NL-16)
  • Fourier transform infrared microscopy (FTIR microscopy) (NL-21)
  • Testing of technical cleanliness according to VDA 19 Part 1 (NL-28)
  • Determination of the cleanliness of medical devices (NL-31)
  • Particle analysis: How to characterise particles generated under dynamic loading of medical devices (NL-34)
  • TOC/TIC/TN: Quantitative analysis of dissolved organic and/or inorganic carbon as well as nitrogen (NL-36)
Equipment:

 

 

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