ASTM F2459-18 testing in a laboratory
As a manufacturer, you would like to carry out an analysis in accordance with the ASTM F2459-18 standard.
What is ASTM F2459-18?
ASTM F2459-18 is a technical specification that sets out standard test methods for the extraction of residues of metallic medical components and their quantification by gravimetric analysis.
Principles of analysis according to ASTM F2459-18
This method (ASTM F2459-18) quantifies residues on metallic medical components after extraction with solvents (1.1).
It proposes two techniques for quantifying extractable residues without imposing a cleanliness threshold and acknowledges the existence of other methods (1.2).
Some forms of residue may not be detected (1.3), and validation for totally metallic components will be carried out via an interlaboratory study (1.4).
It does not apply to medical devices cleaned for reuse or to biocompatibility tests, for which ISO 10993-12 is recommended (1.5).
The units are in SI (1.6), and the user must assess the safety risks (1.7).
Why carry out an ASTM F2459-18 testing?
Carrying out an analysis according to the ASTM F2459-18 standard in the laboratory offers a number of advantages, especially in sensitive industries such as medical devices. Here are the main reasons why:
1. Ensuring the cleanliness of medical components
The standard enables residues on metal components to be quantified, ensuring that they are sufficiently clean for medical use. Laboratory analysis detects potential contaminants that could compromise safety.
2. Compliance with regulations and quality requirements
In the medical device industry, there are strict safety and quality standards. ASTM F2459-18 analysis helps manufacturers meet these requirements by demonstrating that their components meet cleanliness criteria.
3. Preventing the risk of contamination
Non-volatile residues present on medical components can have a negative impact on device performance, or even cause adverse reactions. Analysis enables these risks to be prevented by identifying contaminants before the device is placed on the market.
4. Validation of manufacturing and cleaning processes
The assessment of residues helps to validate the cleaning and manufacturing processes. By performing the analysis according to the standard, manufacturers can adjust their methods to minimise contamination and ensure that their processes comply with industry standards.Analysis of electroplated coatings in accordance with ASTM F2459-18 can be essential for certain manufacturers, as it enables them to ensure the quality of a coating, guarantee the reliability of a product, meet industrial standards, etc.
The FILAB laboratory can help you analyse your electrodeposited coatings in accordance with the ASTM F2459-18 standard.
Thanks to its dual skills in chemistry and materials, the FILAB laboratory has the expertise and analytical tools needed to analyse metallic materials, particularly medical devices, and electroplated coatings according to the standard set by ASTM F2459-18.
Laboratory analysis according to the standard ASTM F2459-18
The analysis offered by the FILAB laboratory aim to guarantee the cleanliness of metallic medical components by quantifying the residues present.
– Gravimetric analysis: Measurement of the mass of non-volatile residues after extraction using aqueous or organic solvents.
– Solvent extraction : Use of solvents to remove and measure residues on metal components.
– Comparative cleanliness test: Comparison of contamination levels between different components or cleaning processes.
– Validation of cleaning processes: Verification of the effectiveness of component cleaning methods.
– Interlaboratory analysis: Validation of the reproducibility of results between laboratories.
– Analysis of electrodeposited coatings
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FAQ
ASTM F2459-18 analysis involves measuring the quantity of non-volatile residues (particulate contaminants) present on medical components after they have been extracted using solvents. This analysis is carried out gravimetrically to determine the mass of residues left after evaporation of the solvent.
The method used is a solvent extraction (aqueous or organic), followed by evaporation of the solvent. The mass of the remaining residues is measured gravimetrically to quantify the contaminants present.
The analysis targets non-volatile residues, which may include solid particles, oily films or contaminants left over from manufacturing or cleaning processes. It does not take into account volatile residues, which evaporate during the process.
The aim of the analysis is to measure the level of cleanliness of the components by detecting any residues remaining after the manufacturing or cleaning stages, thereby ensuring that the components do not contain any contaminants that could compromise their use in a medical context.
The results allow you to compare different cleaning or manufacturing processes to identify which ones leave the least residue. This can help you refine your methods and guarantee a better level of component cleanliness.
Gravimetric analysis measures the amount of residue remaining after cleaning. This helps you validate your cleaning process by proving that it sufficiently reduces contaminants on metal components before they are used.
Yes, this standard is designed for new metal components. It does not apply to medical devices cleaned for re-use, or to residue analysis for biocompatibility testing (for this, please refer to ISO 10993-12).
An electrodeposited coating is applied to a material or object using an electrochemical process known as electroplating. The material to be treated is placed in a solution containing metal ions and a diffused metal current attaches these metal ions to the surface of the material.
The aim of this surface treatment is to improve the appearance, corrosion or wear resistance and electrical properties of many parts. This process is regularly used in the automotive, aerospace, medical devices and jewellery industries, etc.
