Chemical Characterization

Medical products and devices used in the healthcare sector must comply with safety and quality standards because they come into direct contact with human health. Chemical characterization plays a critical role in ensuring the reliability and biocompatibility of these products as an important part of these standards. In this article, we detail the role of chemical characterization in medical products and the importance of this process.

The biological safety of medical devices is of critical importance in ensuring that products are suitable for human health. The ISO 10993 series is an international set of standards that covers the tests and analyses required for medical devices to ensure biological safety. Part 18 of this series, ISO 10993-18, specifically regulates chemical characterization processes for medical devices and provides a detailed analysis of the chemical components contained in the devices.

What is Chemical Characterization?

Chemical characterization is the process of analyzing the chemical profiles of a product's components. In medical products and devices, material components are examined through various chemical tests to determine whether they have any adverse effects on health. These analyses enable the identification of potential toxic components and the implementation of safety measures.

• Comprehensive Extraction
• FTIR test for non-volatile residues or extracts - ISO 10993-18, ISO 10993-12, ISO 10993-17
• GC-MS testing for volatile and semi-volatile organic extracts - ISO 10993-18, ISO 10993-12, ISO 10993-17
• ICP-MS testing for inorganic and heavy metal extracts - ISO 10993-18, ISO 10993-12, ISO 10993-17
• LC-MS testing for non-volatile organic extracts - ISO 10993-18, ISO 10993-12, ISO 10993-17
• UV-Vis spectrophotometry to evaluate the colorant
• Viscosity, pH

Purpose and Scope of ISO 10993-18 Standard

ISO 10993-18 addresses chemical characterization as a fundamental step in the safety assessment of medical devices. This standard aims to ensure the safe identification of the chemical components of devices and the assessment of potential risks. By providing a detailed analysis of the chemical substances present in devices, it offers guidance on determining whether these substances may cause any toxic effects when they come into contact with the human body.

Why is chemical characterization important?

Chemical characterization is required as part of biocompatibility testing and international standards (e.g., ISO 10993) to ensure product safety. These analyses help determine whether the chemical substances contained in products have any harmful effects on the body. Chemical characterization is mandatory for products such as metal implants, medical hoses, drug carriers, and bandages. This ensures that products undergo a comprehensive safety screening before being released to the market.

Chemical characterization analyses performed in accordance with ISO 10993-18 provide medical device manufacturers with the following advantages:

1. Regulatory Compliance: The ISO 10993-18 standard is recognized by many medical device regulatory agencies around the world. Compliance with these standards allows manufacturers to offer their products in a wider range of markets.
2. Toxicological Safety: When the toxicological safety of chemicals in devices is ensured, patient safety and treatment efficacy are also improved.
3. Ease of R&D Processes: Chemical characterization data is useful in new device development processes to understand the biological compatibility of the device at an early stage.
4. Cost and Time Savings: With chemical characterization, the safety profiles of devices can be determined in advance, reducing the need for repeated biological testing.

Chemical Characterization and Regulatory Requirements

Health authorities worldwide require chemical characterization of medical products. For example, medical device manufacturers seeking CE marking in the European Union must perform chemical characterization as part of ISO 10993 biocompatibility testing. The FDA (US Food and Drug Administration) requires chemical analyses to be integrated with biocompatibility and toxicity tests. These processes ensure that medical products do not pose a risk to human health.

Chemical Characterization Methods

Chemical characterization involves identifying compounds that may originate from the device's production materials, additives, and process byproducts. In medical products, chemical characterization is performed using various analytical techniques. Various analytical methods and tests are used to identify these compounds. Here are some of the most common methods: Chemical characterization of medical products and devices is of great importance for product safety and patient health. This process analyzes the interaction of medical devices with the human body to prevent potential toxic effects and ensure compliance with standards. Reliable analytical methods and compliance with regulatory requirements enhance the effectiveness of chemical characterization in medical products and provide important assurance for patient safety.

1. Extraction Studies: Chemical substances that can be extracted from a medical device are determined based on how the device comes into contact with human tissue. This step is critical for understanding the potential for substances on the device's surface to migrate into tissues.

1. Gas Chromatography (GC) and Mass Spectrometry (MS): Used for the separation and analysis of volatile and semi-volatile organic compounds.
2. Liquid Chromatography Mass Spectrometry (LCMSMS): Preferred for the detection of unstable or non-volatile components. The chemical stability of medical products can be analyzed using this technique.
3. Inductively Coupled Plasma (ICP) Technique: Used for the analysis of metals and is of critical importance in implants.
4. Fourier Transform Infrared Spectroscopy (FTIR): Used to analyze the chemical bond structures of materials. It determines the chemical profiles of polymer-based parts of medical devices such as plastics and rubber.

Why is AET – Analytical Evaluation Threshold Important in Evaluation?

The Analytical Evaluation Threshold (AET) specified in the ISO 10993-18 standard is a critical calculation method used to evaluate the safety of chemical substances released from medical devices.

AET determines the concentration limit of substances that can be released from the device, enabling the assessment of potential toxicological risks. The calculation is based on parameters such as the device's surface area, exposure scenario, and toxicological threshold values. The importance of AET lies in providing an accurate starting point for toxicological risk assessments and determining whether a device meets biocompatibility criteria. This method aims to minimize potential risks from medical devices and improve patient safety.

How is sample preparation performed in accordance with the ISO 10993-12 standard?

The ISO 10993-12 standard serves as the fundamental guideline for determining the extraction conditions to be used in the biological evaluation of medical devices. When applying the ISO 10993-18 standard, the selection of extraction conditions is based on the device's intended use, contact time, contact surface, and chemical properties.

Extraction conditions are optimized to ensure that the maximum levels of potential chemical substances that the medical device may release during use are evaluated. In this process, parameters such as extraction time, temperature, type of extractant (e.g., polar or non-polar solvents), and the device's surface area-to-volume ratio are considered. For example, different conditions apply to a device that comes into prolonged contact with body tissues or fluids compared to one that has only brief contact.

The ISO 10993-12 standard focuses on simulating the device's actual usage scenario when defining these parameters and ensures that an appropriate extraction protocol is determined to obtain reliable results in chemical analyses. As a result, chemical characterization studies conducted under the ISO 10993-18 standard become more accurate and valid.

Why NANOLAB?

Nanolab offers the most reliable and fastest solution in chemical characterization analyses for medical products with its industry experience and strong infrastructure. It meticulously analyzes the chemical components of products to ensure they meet biocompatibility, safety, and quality requirements. Thanks to its ISO 17025 accreditation, analysis results have international validity, and the reliability and suitability of medical products are accurately evaluated. With its extensive equipment fleet and expert technical team, it efficiently and quickly completes chemical characterization processes. Thanks to its regulatory expertise, relevant standards and legal requirements are fully met. Nanolab stands out as the go-to address for medical product analysis, where quality, reliability, and speed converge.