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
Newsletter:  
Equipment: ICP-MS, GC-MS, TOC, TIC, TN, FT-IR

 

 

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 BCA 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): Guideline from DGKH, DGSV and AKI
Newsletter:  
Equipment:
  • Miele Professional washer-disinfector G 7836 CD
  • Autoclave Tuttnauer Elara 10
  • Biotek ELx808 absorption reader
  • TOC, TIC, TN

 

 

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): ISO 10993
Newsletter:  
Equipment:
  • Autoclave Tuttnauer Elara 10
  • Laboratory Rinsing Machine G7783 MIELABOR
  • Drying Cabinet WTB Binder
  • Miele Professional Washer-Disinfector G 7836 CD

 

 

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