Physico-Chemistry – Medical Devices
- Extraction of Total Organic Carbon (TOC) from medical devices (orthopedic implants) in accordance with NF ISO 19227, then determination in accordance with European Pharmacopoeia chapter 2.2.44. and monographs 0008 and 0169 (USP-NF <643> equivalent),
- Determination of ethylene oxide sterilization residues (ethylene oxide, ethylene hydrochloride and ethylene glycol) in accordance with NF EN ISO 10993-7,
- Extraction of total hydrocarbons (IHCT) from medical devices (orthopedic implants) in accordance with NF ISO 19227, then assay according to NF EN ISO 9377-2,
- Extraction of Inorganic Contaminants (CIT) on medical devices (orthopedic implants) according to NF ISO 19227, then assessment of inorganic contamination by indirect method (conductivity measurement) according to
- European Pharmacopoeia chapter 2. 2.38.,
- Extraction of detergent residues from medical devices, then determination by conductivity or Total Organic
- Carbon (TOC) analysis,
- Extraction of particles (subvisible particles) from medical devices (orthopedic implants) in accordance with NF
- ISO 19227, then determination in accordance with European Pharmacopoeia chapter 2.9.19., methods 1 and 2 (USP-NF <788> equivalent),
- Extraction and particle counting in accordance with IEST-STD-CC1246E,
- Particle counting on infusion devices for medical use in accordance with ISO 8536-4, Annex A,
- Particle counting on surgical implants – active implantable medical devices in accordance with NF EN 45502-1 and ISO 14708-1,
- Particle counting on preassembled sterilized pre-fillable syringes in accordance with NF ISO 11040-6,
- Particle counting on plastic containers for intravenous injections in accordance with NF EN ISO 15747,
