Chemical Characterization of Materials in Accordance with ISO 10993-18

ISO 10993-18 is widely recognized and used around the world, including by the Food and Drug Administration (FDA) in the United States, to assess the biological safety of medical devices. 

The FDA uses this standard as part of an overall evaluation of medical device biocompatibility, as specified in its guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'". In this document, the FDA emphasizes the importance of thorough chemical characterization according to ISO 10993-18 as a key step in determining the biological risks associated with medical devices. The agency expects manufacturers to provide complete data on extractables and/or leachables from materials that could affect device safety. FILAB supports you with ensuring your medical device complies with ISO 10993-18 for successful export to the United States 

The FDA recommends using validated and appropriate analytical methods to ensure accurate chemical characterization results. 

To verify compliance with ISO 10993-18, which covers the chemical characterization of medical device materials, a rigorous procedure is followed. 

This process begins with a preliminary assessment that includes the precise identification of the materials making up the medical device and a detailed analysis of the conditions under which it will be used. The next step is to extract chemical substances from the device under conditions that simulate its actual use. These extracts are analyzed using advanced techniques such as gas chromatography (GC), high-performance liquid chromatography (HPLC), and mass spectrometry to identify and quantify the chemical compounds present.

The potential toxicity of the extracted substances is assessed, and additional analyses may be required, such as inductively coupled plasma mass spectrometry (ICP-MS) for heavy metals, and specific techniques for volatile compounds or plasticizers. 

The documentation and reporting of these results must clearly demonstrate compliance with the requirements set out in ISO 10993-18, scientifically justifying that the materials used do not pose any significant risk to patients. It is often wise to call on an expert laboratory in chemical characterization to ensure the accuracy and compliance of the analyses performed.

ISO 10993-18 is specifically dedicated to the chemical characterization of materials used in medical devices. Here are some techniques used to carry out chemical characterization according to this standard:

1. Extraction: Materials are exposed to suitable solvents under controlled conditions (temperature, time, and environment) to extract potentially releasable chemical substances, in order to simulate the real conditions of use of the medical device.
2. Chromatography (GC) and (HPLC): These techniques are used to separate, identify, and quantify the chemical compounds present in the extracts.
3. Mass spectrometry (MS): Coupled with GC or HPLC, mass spectrometry makes it possible to determine the molecular structure of the detected components, in order to accurately identify chemical substances, including contaminant analyses.
4. ICP-MS analysis: Used to quantify metals and inorganic elements in extracts, due to its sensitivity for detecting heavy metals.
5. Analysis of volatile organic compounds (VOCs) to identify and quantify VOCs that could be released by the materials.
6. Analysis of additives and plasticizers: Identification and quantification of substances such as plasticizers (e.g., phthalates), stabilizers, and antioxidants, which are often used in the manufacture of plastic medical devices.

These techniques are essential to ensure that the materials used in medical devices meet the required safety and performance standards, thereby minimizing risks to patients.

FILAB laboratory, recognized for its expertise in materials analysis and consulting, particularly in the medical sector, offers ISO 10993-18 training.

ISO 10993-18 is part of the ISO 10993 series, which concerns the biological evaluation of medical devices. It focuses specifically on the chemical characterization of the materials used in these devices. A detailed analysis of potentially released chemical compounds makes it possible to demonstrate the device's safety with regard to regulations, and during prolonged or repeated contact. 

The tests carried out include chemical analyses to identify and quantify substances extracted from materials when they are subjected to conditions simulating their actual use. This may include extraction in representative solvents, followed by analyses such as gas chromatography (GC-MS), liquid chromatography (HPLC), and mass spectrometry (MS). These methods make it possible to detect impurities, additives, and by-products.

The need to carry out chemical characterization depends on the nature of the material and the intended use of the medical device. If your device comes into direct or indirect contact with the human body (for example, an implant or an internal-use device), analysis according to ISO 10993-18 is generally required.

Extractables are substances that can be extracted from the material when it is subjected to exaggerated conditions (for example, high temperature or aggressive solvents), whereas leachables are substances that can be released under normal conditions of use. Assessing both types of substances is important to ensure that no potentially harmful compound is released during the clinical use of the device.

Non-compliant chemical characterization can lead to delays in bringing the medical device to market, or even to a refusal of authorization by regulatory bodies. Additional testing may also be required. It is essential to work with a qualified laboratory that understands the requirements of the standard.

Make sure the laboratory has ISO 17025 accreditation, which guarantees technical competence and reliable analytical results. A laboratory with experience in the medical device sector and chemical analyses is also a mark of quality.

The ISO 10993-18 standard requires thorough chemical characterization of materials to identify potentially toxic substances in implantable medical devices. Once these substances are detected, a toxicological assessment is carried out to determine whether they pose a health risk, particularly by taking into account prolonged exposure in the body. The results are compared with established safety thresholds, and if necessary, additional studies are conducted to verify the absence of long-term adverse effects.

Chemical characterization of a medical device consists of identifying and quantifying the chemical substances present in a material. It makes it possible to verify that the medical device does not release compounds that are hazardous to health during use. 

Carried out according to standards such as ISO 10993-18, it assesses extractables and leachables using advanced techniques. This analysis is essential to ensure the safety and biocompatibility of the medical device.