Validation of HCT / TOC cleaning residues

Cleaning is a major issue for the biological safety of medical devices. The level of cleanliness is essential to ensure its biocompatibility.

The validation of cleaning processes makes it possible to claim sterile status for devices.


Total Hydrocarbon (HCT) and Total Organic Carbon (TOC) analyzes on medical devices

HCT analysis makes it possible to quantify the mass of hydrocarbons extracted in an apolar solvent (such as hexane) while TOC analysis makes it possible to quantify the mass of carbonaceous (organic) substances extracted in water. The COT and HCT methods make it possible to quantify a broad spectrum of specific organic contaminants.

  • Solid / Liquid Extraction of MD based on NF EN ISO 10993-12
  • HCT analysis according to Standard NF EN ISO 9377-2 by GCMS
  • TOC analysis according to Standard NF EN 1484 by TOC-meter

HCT et COT sur dispositifs médicaux

Other examples of services for medical devices:

Determination of residual HCT / TOC in medical devices (Based on standards NF EN ISO 9377-2 and 1484)
Determination of residual HCT/TOC in medical devices

Determination of residual HCT/TOC in medical devices

MDs must meet strict standards because they are implanted inside the body. The presence of stains, inclusion or any other defect renders..
Task analyzes on orthopedic prostheses

Task analyzes on orthopedic prostheses

Medical devices are subject to standard 10993-7 which specifies the permissible limits of residues of ethylene oxide and ethylene..
Biological evaluation of medical devices - Standard 10993-7

Biological evaluation of medical devices - Standard 10993-7

Standards 10993-12 and 18 deal with the extraction of materials and analysis techniques allowing us to identify and quantify the elements..
10993 -12 & 18

10993 -12 & 18

CONTACT US