Analysis and determination of cleaning residue : THC, TOC and detergent residue on Medical devices

FILAB is the first laboratory to be ISO 17025 accredited by COFRAC for TCH and TOC analyses of Medical Devices and Equipment in accordance with the ISO 19227 set (previously known as NF S94-09)

Your needs : to have your MD cleaning procedures validated in accordance with relevant standards

The cleaning process is crucial when manufacturing medical implants. With the aim of eliminating any residual contaminants, the manufacturer of a medical device must adapt the cleaning process to their own needs or to those of their client by precisely identifying the type of contaminant involved in the manufacturing process of the implant, in the way it’s going to be handled and in the way it will packaged and stored (lubricants, particulates, detergent residue, inorganic residue…)

Among other things, the NF S94-091 standard defined which factors needed to be taken into account when validating the cleaning process which orthopedic implants undergo before being packaged.

The development and implementation of specific analytical techniques (determination of heavy metals, THC and TOC analyses) is a key step in evaluating the cleanliness of medical implants.

Our solution : to provide you with our know-how and our COFRAC certified analytical tools to help develop and validate your cleaning procedures

FILAB is ISO 17025 accredited by COFRAC for Total HydroCarbons (THC) analysis and Total Organic Carbons (TOC) analysis of Medical Devices and Equipment in accordance with the ISO 19227 set (previously known as NF S94-09) :

–        ISO 9377-2 for THCs

–        EN 1484 for TOCs

We are therefore the first laboratory in France to be ISO 17025 accredited for medical devices. For more information visit : www.cofrac.fr

Our experts are at your disposal and offer their analytical services for cleaning residue, THC, TOC, detergent residue, acids and heavy metals :

  • THC analysis of  Medical Devices (orthopedic implants, implantable devices…) using GC in accordance with ISO 9377-2 (THCs : presence of lubricants, cutting oil…)
  • TOC analysis of Medical Devices (orthopedic implants, implantable devices…) using a TOC-meter in accordance with EN 1484
  • HCT / COT dissolution, extraction in accordance with ISO 10993-12 or lixiviation analysis
  • Validation of cleaning procedures in accordance with ISO 19227:2018
  • Evaluation of the efficiency of an extraction technique in accordance with ISO 10993-12
  • Analysis and determination of detergent residue using ICP and Ionic Chromatography
  • Analysis and determination of inorganic residue using ICP and Ionic Chromatography
  • Acid analysis using ICP and Ionic Chromatography
  • Residual analysis of aluminum based polishing paste
  • Biocompatibility testing in accordance with ISO 10993-18
  • Analytical development for determining THCs and TOCs on Medical devices
  • Analytical validation for determining TCHs and TOCs on DMs
  • Analytical services and validation in a laboratory
  • Surface and extremity analysis using XPS and/or ToF-SIMS
  • Unknown pollutant analysis (embedded or not)
  • Identification and quantification of potential degradation products in accordance with the ISO 10993 set
Thank you !

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