Coating inspection and particle characterisation according to ASTM F 2743
You need coating analysis and particle characterisation according to ASTM F2743
First, the acronym ASTM F2743 refers to a standard guide for coating inspection and acute particle characterisation of coated drug-eluting stents.
The test standards describe recommended in vitro test procedures for assessing the acute durability of the coating of drug-eluting stent systems. Clinical performance (i.e. drug elution) may be affected by coating durability. Balloon expandable and self-expanding stents are included in the scope. Recommended practices for assessing acute coating durability include baseline (deployment) and simulated use tests. This guide describes the capture and analysis of any released particles and the inspection of the surface of the coated stent.
This type of analysis requires a number of precision instruments such as the scanning electron microscope.
Therefore, only a laboratory with state-of-the-art analytical equipment is able to perform coating inspection and particle characterisation according to ASTM F2743.
FILAB offers coating inspection and particle characterisation services according to ASTM F2743
In order to support manufacturers in the development and quality control of their metal parts resulting from additive manufacturing, by following the regulatory evolutions, the FILAB laboratory provides a state-of-the-art analytical park of 2100m² allowing the control and qualification of metal parts resulting from additive manufacturing according to ASTM F2743.
Thanks to its high level of in-house expertise and tailor-made support, FILAB can offer you solutions tailored to your needs.
PAH coating stands for Polyaromatic Hydrocarbon coating. It is a type of surface modification technique that can be used to enhance the biocompatibility of medical implants. PAH coatings are typically applied to the surface of the implant via a process known as plasma-enhanced chemical vapor deposition (PECVD).
PAH coatings can improve the biocompatibility of implants by promoting cell adhesion and growth. The coating's hydrophobicity and chemical composition can also play a role in reducing inflammation and encouraging bone ingrowth.
Research has shown that PAH coatings can be effective in promoting osseointegration, or the integration of the implant with surrounding bone tissue. This can help improve the long-term stability and success of the implant.
PAH coating has been applied to various types of implants, including orthopedic implants such as joint replacements, dental implants, and cardiovascular implants such as stents.
It is important to measure the implant surface porosity of porous coatings according to ASTM F1854. This standard specifies various tests, including Mercury Intrusion Porosimetry (MIP), Gas Pycnometry, Image Analysis, Water Contact Angle, and Scanning Electron Microscopy (SEM), that can be used to evaluate the quality and porosity of the porous coating on the implant surface. Proper evaluation of the implant surface porosity is critical for achieving adequate biological fixation and improving patient outcomes. While techniques such as PAH coating can enhance the biocompatibility of the implant, they should be used in conjunction with proper evaluation of the implant surface porosity according to ASTM F1854 to ensure the implant's safety and efficacy.
Measuring the implant surface porosity according to ASTM F1854 is essential because it helps ensure that the implant will have the appropriate level of biological fixation. Porosity is a critical factor in determining how well an implant will integrate with natural bone tissue. If an implant has too little porosity, its surface area may be too smooth to effectively bond with surrounding bone, resulting in poor fixation and potentially causing implant failure.
Conversely, if an implant has too much porosity, it may not be strong enough to withstand normal biomechanical stresses, leading to premature wear or fracture. ASTM F1854 provides a standardized method for measuring implant porosity, which helps ensure that implants are manufactured with the appropriate level of porosity for their intended application, improving patient outcomes and reducing the risk of implant failure.
ASTM F1854 specifies several tests that can be used to measure the surface porosity of implants. Here are some of the most common tests:
- Mercury Intrusion Porosimetry (MIP): This test involves filling the pores of the implant surface with mercury under pressure and measuring the volume of mercury that is intruded into the pores. This method provides information on the size distribution and volume of the pores.
- Gas Pycnometry: This test measures the density of the implant by comparing its volume to the mass of a gas displaced by the implant. This method can be used to calculate the volume of open pores on the implant surface.
- Image Analysis: This test involves analyzing images of the implant surface to quantify the pore size, shape, and distribution. This method can provide information on both open and closed pores.
- Water Contact Angle: This test measures the hydrophilicity or hydrophobicity of the implant surface. A higher contact angle indicates a more hydrophobic surface, suggesting lower porosity.
- Scanning Electron Microscopy (SEM): SEM can be used to observe and measure the size and distribution of pores on the implant surface. This method provides high-resolution images of the implant surface, allowing for a detailed analysis of the porosity.
These tests can be used individually or in combination to measure the surface porosity of implants according to ASTM F1854.
