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parts2clean, 22 - 24 October 2019
Homepage>Exhibitors & Products >Laboratory Analysis - Medical Devices

Laboratory Analysis - Medical Devices

Logo CleanControlling

Exhibitor

CleanControlling

Exhibitor details
Exhibitor details
Logo Laboratory Analysis - Medical Devices
Logo Laboratory Analysis - Medical Devices

Product description

BIOLOGICAL TESTS
In-vitro cytotoxicity test as per DIN EN ISO 10993-5
Determination of bioburden including validation as per DIN EN ISO 11737-1
Endotoxin test (LAL test) as per USP 85/ Ph. Eur. 2.6.14
Sterility test as per DIN EN ISO 11737-2
Evaluation of contact plates for microbiological environment monitoring

PARTICULATE TESTS
Particulate contamination testing using an optical particle counter (OPC) based on USP 788 or microscopic evaluation based on ISO 16232 or USP 788.

FURTHER TESTS
Chemical analyses, e.g. GC-MS, LC-MS , TOC , THC , ICP-MS/Headspace-GC-MS
In vitro pyrogen test (IPT)
Testing of the product surface, e.g. REM/EDX, XPS

VALIDATION OF REPROCESSING AND STERILIZATION PROCESSES
Tests within the validation of information in processing instructions provided by the medical device manufacturer for reprocessing and sterilization processes acc.
DIN EN ISO 17664 and ISO 17665-1 for
manual or automated processing of medical devices
steam sterilization of medical devices

VALIDATION OF FINAL CLEANING PROCESS
Tests within the validation of the final cleaning of medical devices:
In-vitro cytotoxicity test acc. DIN EN ISO 10993-5
Examination of particulate contamination based on USP 788
TOC and THC determination
Determination of bioburden acc. DIN EN ISO 11737-1
Endotoxin test (LAL test)

BIOCOMPATIBILITY OF MEDICAL DEVICES
Tests to determine biocompatibility of medical devices according to the amendment of DIN EN ISO 10993-1:
In-vitro cytotoxicity test acc. DIN EN ISO 10993-5
Sample preparation for biological and chemical evaluation of medical devices acc. DIN EN ISO 10993-12
Chemical characterization acc. DIN EN ISO 10993-18: GC-MS / THC / ICP-MS / LC-MS / Headspace-GC-MS
Toxicological short evaluation
Toxicological / biological evaluation of chemical analysis of medical devices according to DIN EN ISO 10993-17

Hall 9, Stand B56

(Main stand)

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