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SGS SERCOVAM Cestas
BP 10 - 33611 CESTAS - FRANCE
T +33 (0) 5 57 97 02 33
F +33 (0) 5 57 83 53 73
SGS SERCOVAM Etupes
BP 61059 - 25460 ETUPES - FRANCE
T +33 (0) 3 81 32 24 30
F +33 (0) 3 81 32 22 62
TESTS ON MEDICAL DEVICES - IMPLANTS
BIOCOMPATIBILITY TESTS AND ANALYSIS OF TOC / HTC
SGS SERCOVAM can test biocompatibility of medical devices according to: • ISO 10993-12 (ISO10993-12): Biological evaluation of medical devices -part 12: sample preparation and reference materials • ISO 10993-17 (ISO10993-17): Biological evaluation of medical devices - part 17: establishment of allowable limits for leachable substances • ISO 10993-18 (ISO10933-18) : Biological evaluation of medical devices - part 18: chemical characterization of materials In addition to these measures, analyzes of TOC and HCT may be performed to validate the cleaning of implants: • Analysis of Total Organic Carbon (TOC) according to NFEN 1484 (NFEN1484): Waters analysis- Guidelines for the determination of total organic carbon (TOC) and dissolved organic carbon (DOC) • Analysis of Carbonic Total hydrocarbons (HTC) according to NFENISO 9377-2 (NFENISO9377-2) Water quality- Determination of hydrocarbon oil index- Part 2 : method using solvent extraction and gas chromatography • Requirements according to XP S94-091 (XPS94-091): Implants for surgery- Validation of the cleaning of orthopedic implants before final conditioning.