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ASTM F2459

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ASTM F2459

ASTM F2459, published by ASTM International: ‘Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis’, i.e. ‘Standard test method for the extraction of residues from metallic medical components and their quantification by gravimetric analysis’.

Note on regulatory status: The standard is used in particular for the cleaning validation of orthopaedic implants, surgical instruments, dental implants and other metallic medical devices. It is frequently used as a reference when validating cleaning requirements in production processes within the framework of the EU MDR (2017/745), the FDA and ISO 13485. The standard is used in particular in conjunction with ISO 19227 (Cleanliness of orthopaedic implants), ASTM F2847 (Reporting and evaluation of test data for the cleaning of medical devices) and ASTM F3127 (Validation of cleaning processes for medical devices).

Basic principle

The method is used to extract residues (e.g. oils, machining fluids, particles, cleaning agent residues, metal dusts) using a suitable solvent, and to quantify the extract by means of gravimetric (weight-based) analysis. Typical steps:

  • Weighing and preparing the sample
  • Selecting a suitable extraction solvent
  • Extraction under specified conditions (ultrasonic bath, Soxhlet, reflux, immersion, etc.)
  • Transfer of the extract to a suitable container and evaporation
  • Adjusting the balance to a constant weight and weighing
  • Blind value correction and calculation of the results

What is it for?

ASTM F2459 is used for the following scientific, technical and regulatory purposes:

  • Cleaning validation: Determination of the level of surface residues on metallic components following manufacture, processing and cleaning, and verification of the effectiveness of the cleaning processes
  • Contribution to biocompatibility assessment: Assessment of the potential effects of residues on biocompatibility (in conjunction with ISO 10993-1, ISO 10993-18)
  • Ensuring patient safety: reducing risks posed by residues on implantable devices and surgical instruments
  • MDR compliance: Provision of the necessary data for the control of the manufacturing process and biological safety within the framework of the EU Medical Devices Regulation (2017/745)
  • Integration with ISO 19227: Assessment of cleaning requirements for orthopaedic implants
  • Control of the production process: Monitoring the impact of processing, cleaning, coating and packaging processes on residue levels
  • Quality control: Monitoring consistency between production batches
  • Assessment of changes to suppliers and processes: Assessment of the impact of changes to materials, solvents, cleaning agents or processes on residue levels
  • Support with regulatory submissions: Use as evidence of cleaning validation for FDA 510(k), EU MDR and other applications
  • Approach to determining the level of evidence: a contribution to the holistic assessment of the ingredient in conjunction with ISO 19227, ISO 10993 and other analytical data

ASTM F2459 determines the total amount of residues; it does not provide direct information on the chemical nature, toxicological profile or biocompatibility of the residues. The results should be interpreted in conjunction with supplementary analytical methods and biocompatibility assessments.

As NanoTest, we carry out residue extraction and gravimetric analyses in accordance with ASTM F2459, applying scientific rigour within the framework of our accredited laboratory infrastructure and our quality management system.

For information on experimental design, extraction methods and solvent selection, gravimetric analysis, supplementary characterisation, test schedules and report preparation in the context of residue extraction and gravimetric determination in accordance with ASTM F2459, please feel free to contact NanoTest.

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