Medical Device characterization in accordance with the ISO 10993-19 standard
FILAB laboratory is able to assist you in characterizing your medical devices in accordance with the ISO 10993-19 standard
The ISO 10993-19 standard provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, physicochemical, morphological and topographical (PMT) properties of materials in finished medical devices. PMT parameters play an important role in evaluating the biocompatibility and the clinical efficiency of medical devices.
The ISO 10993-19 standard therefore states which properties are to be taken into consideration when characterizing the PMT parameters of materials containing polymers, metals, alloys, ceramics, and natural macromolecules.
With support from a partner laboratory, FILAB is able to assist you in evaluating the biocompatibility of your Medical Devices by conducting the following tests :
Our tests
Degradation testing in accordance with the ISO 10993-13, ISO 10993-14 and ISO 10993-15 standards
Chemical characterization in accordance with the ISO 10993-18 standard
Nanomaterial characterization in accordance with the ISO 10993-22 standard
We are also able to provide the following services :
Our services
Skin irritation testing in accordance with the ISO 10993-10 standard
Toxicological evaluations of leachable substances in accordance with the ISO 10993-17 standard
The fact that we work on a human scale, our continuous investments and our extensive knowledge of the field of Medical Devices all ensure the reliability of our results, a quick turnaround for requests and tailored support suited to your needs.
Choosing an ISO 10993-19 certified laboratory is important for several reasons:
- Compliance with Regulatory Requirements: Regulatory agencies such as the European Medicines Agency (EMA) require medical device manufacturers to provide comprehensive data on the physico-chemical, morphological, and topographical characterization of materials used in their devices. Working with an ISO 10993-19 certified laboratory can help ensure that your testing meets these regulatory requirements.
- Expertise and Experience: An ISO 10993-19 certified laboratory has the expertise and experience necessary to conduct thorough material characterization testing. The lab personnel are trained in the specific techniques and methods required for these tests, and they have a deep understanding of the relevant regulations and guidelines.
- Quality Assurance: An ISO 10993-19 certified laboratory must adhere to stringent quality assurance and quality control standards. This means that the lab follows established protocols for sample preparation, testing, and data analysis, ensuring that the results are accurate, reproducible, and reliable.
- Risk Mitigation: Failure to adequately characterize the materials used in a medical device can lead to product recalls, safety issues, and legal liability. Choosing an ISO 10993-19 certified laboratory can help mitigate these risks by ensuring that your device materials are thoroughly tested and meet all applicable safety standards.
ISO 10993-19 is a standard that provides guidance on the physico-chemical, morphological, and topographical characterization of materials used in medical devices. The standard outlines several mandatory clauses that must be met to ensure that materials are thoroughly characterized and safe for use in medical devices. These include:
- Sample Preparation: This clause outlines the requirements for preparing samples for testing, including the size, shape, and number of samples required.
- Identification of Materials: This clause requires the identification of all materials used in the device, including any additives or impurities that may be present.
- Physico-Chemical Properties: This section outlines the tests required to evaluate the physico-chemical properties of the materials, such as solubility, pH, and viscosity.
- Morphological and Topographical Characterization: This clause requires the evaluation of the morphology and topography of the materials, including their surface area, porosity, and roughness.
- Surface Properties: This clause outlines the requirements for evaluating the surface properties of the materials, including surface tension, contact angle, and surface energy.
- Chemical Characterization: This clause requires the identification and quantification of chemical substances present in the device, including any additives or impurities that may be introduced during the manufacturing process.
- Biological Evaluation: This clause requires manufacturers to conduct in vitro and/or in vivo biological evaluations to assess the biocompatibility of the materials.
ISO 10993-19 outlines several methods for the characterization of materials used in medical devices. These methods can be broadly categorized into three groups: physico-chemical characterization, morphological characterization, and topographical characterization. Some of the main methods used in each of these areas include:
Physico-Chemical Characterization:
- Fourier Transform Infrared (FTIR) Spectroscopy
- Thermogravimetric Analysis (TGA)
- Differential Scanning Calorimetry (DSC)
- X-ray Photoelectron Spectroscopy (XPS)
- Atomic Absorption Spectroscopy (AAS)
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Gas Chromatography-Mass Spectrometry (GC-MS)
Morphological Characterization:
- Scanning Electron Microscopy (SEM)
- Transmission Electron Microscopy (TEM)
- Atomic Force Microscopy (AFM)
- Confocal Laser Scanning Microscopy (CLSM)
- Light Scattering Techniques
- Mechanical Profiling
Topographical Characterization:
- Contact Angle Goniometry
- Surface Roughness Measurements
- Scanning Probe Microscopy (SPM)
- Optical Profilometry
Overall, these methods are used to evaluate various aspects of a material's properties, such as chemical composition, thermal stability, morphology, surface topography, and wettability. The results of these tests are critical for ensuring that the materials used in medical devices are safe, effective, and meet all regulatory requirements.
