ISO 10993-18 Non-Volatile Organic Compounds Analysis by LC-MS\/MS
The analysis of non-volatile organic compounds (NVOCs) in medical devices is critical for ensuring the safety and efficacy of these products. ISO 10993-18 provides a standardized approach to identify potential NVOCs that could migrate from a device into a body fluid during use, which may pose health risks if they are toxic or cause adverse reactions.
The analysis involves several key steps: sample preparation, extraction of NVOCs, and subsequent detection using Liquid Chromatography-Mass Spectrometry (LC-MS\/MS). This method ensures the accurate identification and quantification of NVOCs present in a medical device. The results are used to determine whether the device complies with regulatory requirements and to identify any potential risks associated with its use.
Our laboratory uses state-of-the-art LC-MS\/MS instrumentation, which allows for high precision and sensitivity in detecting even trace amounts of NVOCs. This technology is essential for ensuring that the results are reliable and reproducible. The equipment we use adheres to international standards such as ISO 10993-18, ASTM E2657, and EN ISO 14971, which helps ensure consistency in our testing methods.
The process begins with thorough sample preparation, where the device is cleaned according to specific protocols. Extraction of NVOCs requires careful selection of solvents and conditions to avoid loss or alteration of compounds. Once extracted, the NVOCs are then analyzed using LC-MS\/MS, which separates them based on their retention time and mass-to-charge ratio.
The results from this analysis provide detailed information about the types and concentrations of NVOCs present in the device. This data is crucial for assessing the potential risks associated with the use of the device. Our team of experts ensures that all steps are carried out meticulously to meet the stringent requirements set forth by ISO 10993-18.
By adhering strictly to these standards, we can provide clients with reliable and accurate results that help them make informed decisions regarding their products' safety and compliance. This service is essential for manufacturers who need to demonstrate conformance to regulatory requirements and ensure the quality of their medical devices.
Why It Matters
The analysis of NVOCs in medical devices is crucial because it helps identify potential risks associated with device use. NVOCs can migrate from the device into body fluids, such as blood or tissue, and may cause adverse health effects if they are toxic or reactive. By identifying these compounds early in the development process, manufacturers can take corrective actions to mitigate risks.
Compliance with ISO 10993-18 is not only essential for regulatory approval but also helps protect the reputation of the manufacturer and builds trust among healthcare providers and patients. The results from this analysis provide valuable insights into the device's safety profile, allowing manufacturers to make data-driven decisions that prioritize patient well-being.
Our laboratory plays a vital role in ensuring that medical devices meet these stringent requirements by providing accurate and reliable NVOC analysis services. By leveraging our expertise and state-of-the-art equipment, we can help manufacturers comply with regulatory standards and reduce the risk of adverse events associated with their products.
Scope and Methodology
| Step | Description |
|---|---|
| Sample Preparation | The device is cleaned using appropriate protocols to ensure that all NVOCs are present in the sample. This step may include soaking the device in solvents followed by drying. |
| NVOC Extraction | Extract NVOCs using a suitable solvent and conditions to avoid loss or alteration of compounds. The extraction method must be validated for its efficiency. |
| Liquid Chromatography-Mass Spectrometry (LC-MS\/MS) Analysis | Separate and identify NVOCs based on their retention time and mass-to-charge ratio. Calibration standards are used to ensure accurate quantification. |
| Data Interpretation | Analyze the results to determine the types and concentrations of NVOCs present in the device. Compare these findings with established limits for acceptable levels. |
The methodology we use is designed to be robust, reproducible, and compliant with international standards such as ISO 10993-18. Our experienced team ensures that every step of the process adheres to these guidelines, providing clients with confidence in our results.
Customer Impact and Satisfaction
The NVOC analysis service we provide has a significant impact on customers by helping them meet regulatory requirements and ensuring the safety of their medical devices. Our clients benefit from reliable data that informs critical decisions about product development, quality assurance, and patient safety.
We have worked with numerous leading medical device manufacturers who rely on our expertise to ensure compliance with ISO 10993-18 standards. These collaborations have resulted in improved products and increased trust among healthcare professionals and patients. Our customers appreciate the high level of service and support we provide, which goes beyond mere testing.
Our team is committed to delivering accurate results that help our clients make informed decisions about their products' safety and efficacy. We are dedicated to providing exceptional service and support throughout the entire process, from initial consultation through final reporting.
