Accelerated Ageing of Implantable, Ultra-Light, Knitted Medical Devices Modified by Low-Temperature Plasma Treatment - Part 2. Effect on chemical Purity

Abstract

The impact of simulated storage conditions (accelerated ageing) for the chemical purity of innovative ultra-light textile implants (knitted) designed for use in urogynaecology and general surgery (procedures in the treatment of female incontinence, in hernia treatment and vagina plastic surgery) was estimated. The chemical purity of the knitted implants designed: untreated and with low-temperature plasma surface treatment in the presence of the fluoroorganic compounds was estimated. The acceptability of the risk related to the impact of storage conditions on the chemical purity of the implant products was simulated. The examination was based on Standard PN-EN ISO 10993-18:2008: “Biological evaluation of medical devices - Part 18: Chemical characterisation of materials” and was assessed in accordance with Polish and European standards.