Chemical characterization of materials in accordance with ISO 10993-18

As a manufacturer, you want to carry out a chemical characterisation of your materials in accordance with the ISO 10993-18 standard.

ISO 10993-18 and medical devices

ISO 10993-18 describes a process for identifying a material and determining and quantifying its chemical makeup. The chemical characterization of a material allows us to :

Better understand a material from a biological safety point of view (Biocompatibility testing in accordance with the ISO 10993 set)
Testing for leachable substances from Medical Devices
Measuring the amount of material used in medical devices in the context of double or multisource

How can you carry out effective chemical characterisation of your materials in accordance with ISO 10993-18?

Chemical characterization of a material used in medical devices must be representative of the chemical nature, the physical form and the clinical exposure duration and the duration in particular must be calculated based on toxicological risk factors.

The success or failure of chemical characterization depends on collaboration and the exchange of information between characterization specialists, analytical specialists and toxicologists.   

It is important to note that the ISO 10993-18 regulation does not involve the identification or the quantification or degradation products from polymer-based, ceramic or metallic materials as these aspects are covered by other regulations relating to Medical Devices. 

The FILAB laboratory is ISO 17025 accredited by COFRAC for chemical characterization of materials in accordance with ISO 10993-18

Why call on FILAB for the chemical characterisation of your materials in accordance with the ISO 10993-18 standard?

For over ten years, FILAB laboratory has been developing a wide skillset in analytical chemistry and material characterization and has been collaborating with toxicology experts to provide the best characterization services for your biomaterials :

Chemical characterisation in accordance with iso 10993-18

  • Calculation of AET

  • Research and determination of organic residues by GC/MS, LC, HS/GCMS

  • Identification of impurities by LC-QTOF (database of over 1000 substances)

FDA guideline for ISO 10993-18

What's about FDA biocompatibility ISO 10993-18 ?

Additional tests may be required by the FDA (American Food and Drug Administration).

The FILAB laboratory also assists medical device manufacturers with other biocompatibility-related tests, or for any other analyses linked to the development or optimisation of a device:

Our services dedicated to medical devices

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

FAQ

Yes, chemical characterization of medical devices is usually mandatory for regulatory approval in most countries. Regulatory agencies such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) require manufacturers to provide detailed information on the chemical composition of their medical devices as part of the regulatory submission process.

 

The objective of this requirement is to ensure that the device materials and any additives or impurities are safe for their intended use and do not pose a risk to human health. The regulatory agencies review the results of chemical characterization studies to determine if the device meets safety and efficacy standards before granting approval for marketing and distribution.

 

The specific requirements for chemical characterization may vary depending on the type of device, its intended use, and the regulatory agency responsible for reviewing the submission. However, in general, manufacturers must provide comprehensive data on the chemical substances present in the device, including any potential leachables or extractables that could be released into the body or surrounding environment.

 

Overall, chemical characterization is an essential step in the regulatory approval process for medical devices, and manufacturers must ensure that they meet all applicable requirements before submitting their devices for review.

Chemical characterization of medical devices is a critical step in ensuring their safety and efficacy. It involves the identification and quantification of the chemical substances present in the device, including any additives or impurities that may be introduced during the manufacturing process.

 

The process typically involves a combination of analytical techniques, such as chromatography, mass spectrometry, and spectroscopy. These techniques can be used to identify and measure the levels of various chemical compounds, such as monomers, plasticizers, stabilizers, and other additives.

 

In addition, the testing may involve evaluation of the potential for leaching of chemicals from the device into body tissues or fluids. This may involve testing the device under simulated conditions that mimic actual use, as well as analyzing extracted solutions using the same analytical techniques previously mentioned.

 

Overall, thorough chemical characterization is an essential component of medical device development and regulatory submission, as it provides critical information for evaluating the safety, efficacy, and quality of the device.

 

Chemical characterization and material characterization are both important aspects of medical device development, but they differ in their focus and scope.

 

Chemical characterization focuses on the identification and quantification of chemical substances present in the device, including any additives or impurities that may be introduced during the manufacturing process. The goal is to understand the nature and quantity of chemicals that may be released from the device into the body or surrounding environment, and to ensure that they do not pose a risk to human health.

 

Material characterization, on the other hand, focuses on the physical and mechanical properties of the materials used in the device. This includes evaluating the strength, durability, biocompatibility, and other characteristics of the materials to ensure that they are suitable for their intended use.

 

While there is some overlap between these two areas of characterization, they are distinct in their focus and methods. Chemical characterization typically involves analytical techniques such as chromatography and mass spectrometry to identify and measure the levels of various chemical compounds, while material characterization may involve mechanical testing, microscopy, and other methods to evaluate physical properties.

 

Anaïs DECAUX
Anaïs DECAUX Customer Support Manager
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