Chemical characterization of materials in accordance with ISO 10993-18

ISO 10993-18 is widely recognised and used throughout the world, including by the US Food and Drug Administration ( FDA), to assess the biological safety of medical devices.

The FDA uses this standard as part of an overall assessment of the biocompatibility of medical devices, 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 emphasises the importance of thorough chemical characterisation in accordance with ISO 10993-18 as a key step in determining the biological risks associated with medical devices. The agency expects manufacturers to provide comprehensive data on extractable and/or releasable substances in materials that could influence device safety. FILAB can help you ensure that your medical device complies withISO 10993-18 for successful export to the United States.

The FDA recommends the use of appropriate validated analytical methods to ensure the accuracy of chemical characterisation results.

To check compliance with ISO 10993-18, which covers the chemical characterisation of medical device materials, according to a rigorous procedure.

This begins with a preliminary assessment, which includes precise identification of the materials making up the medical device and a detailed analysis of the conditions under which it will be used. The chemical substances are then extracted from the device under conditions that simulate its actual use. These extracts are analysed 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 it may be necessary to carry out additional analyses such as inductively coupled plasma mass spectrometry (ICP-MS) for heavy metals, and specific techniques for volatile compounds or plasticisers.

The documentation and reporting of these results must clearly demonstrate compliance with the requirements specified in ISO 10993-18, with scientific justification that the materials used pose no significant risk to patients. It is often advisable to use a laboratory with expertise in chemical characterisation to guarantee the accuracy and conformity of the analyses carried out.

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

1. Extraction: Materials are exposed to appropriate solvents under controlled conditions (temperature, time, and environment) to extract potentially releasable chemicals, in order to simulate actual 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 is used to determine the molecular structure of the components detected, in order to accurately identify chemical substances, including contaminant analyses.
4. ICP-MS analysis: Used for the quantification of metals and inorganic elements in extracts, due to its sensitivity for the detection of heavy metals.
5. Analysis of volatile organic compounds (VOCs) to identify and quantify VOCs that may be released by materials.
6. Analysis of additives and plasticisers: Identification and quantification of substances such as plasticisers (e.g. phthalates), stabilisers 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 efficacy standards, thereby minimising the risks to patients.

The FILAB laboratory, renowned for its expertise in the analysis and assessment of materials, particularly in the medical sector, offers ISO 10993-18 training courses.

ISO 10993-18 is part of the ISO 10993 series, which covers the biological evaluation of medical devices. It focuses specifically on the chemical characterisation of the materials used in these devices. A detailed analysis of the chemical compounds potentially released enables us to demonstrate the safety of the device with regard to regulations, and in the event of prolonged or repeated contact.

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

The need for chemical characterisation 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 a device for internal use), an analysis in accordance with ISO 10993-18 is generally required.

Extractable substances are those that can be extracted from the material when subjected to exaggerated conditions (for example, at high temperature or with aggressive solvents), while leachable substances are those that can be released under normal conditions. 'use. Evaluation of both types of substances is important to ensure that no potentially harmful compounds are released during clinical use of the device.

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

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

The ISO 10993-18 standard requires in-depth 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 taking into account prolonged exposure in the body. The results are compared to established safety thresholds, and if necessary, additional studies are carried out to verify the absence of harmful long-term effects.