Non-Volatile Organic Compounds (NVOCs) Testing
Medical devices must undergo rigorous chemical characterization to ensure patient safety and regulatory compliance. Non-Volatile Organic Compounds (NVOC) Testing is a critical component of this process, focusing on the identification and quantification of organic residues that may leach from device materials. These residues—including plasticizers, antioxidants, degradation byproducts, and processing aids—can pose significant risks if they migrate into the human body, potentially causing toxicity, inflammation, or other adverse biological reactions. NVOC testing is essential for ISO 10993-18 compliance, which mandates the evaluation of extractable and leachable substances in medical devices. By conducting NVOC testing, manufacturers can mitigate risks, enhance biocompatibility, and meet global regulatory requirements from agencies such as the FDA, and EU MDR.
Our Service
Meditronics (a brand of STEMart) provides ISO 10993-18-compliant NVOC testing to support medical device manufacturers in chemical characterization. Our advanced analytical techniques ensure precise detection and quantification of non-volatile organic residues, including:
UHPLC-HRMS
Delivers superior sensitivity and accuracy in identifying trace-level organic compounds.
UPLC‑UV-MS
Combines UV detection with mass spectrometry for comprehensive compound analysis.
LC-MS
Detects and quantifies a broad range of organic molecules, including polar and non-polar compounds.
Gravimetric Analysis
Measures total non-volatile residue (NVR) to assess the overall organic content in device extracts.
Testing Process Overview
1. Extraction – Simulates clinical exposure by extracting compounds under controlled conditions (e.g., polar/non-polar solvents, elevated temperatures, or simulated body fluids).
2. Sample Preparation – Concentrates extracts to enhance detection sensitivity for trace-level compounds.
3. Instrumental Analysis – Utilizes UHPLC-HRMS, UPLC‑UV-MS, HPLC, LC-MS, and gravimetric analysis to identify and quantify NVOCs.
4. Data Interpretation & Reporting – Provides detailed reports with toxicological risk assessments (per ISO 10993-17) to support regulatory submissions.
Why Choose Meditronics?
Meditronics is a trusted partner for medical device manufacturers, offering unparalleled expertise in chemical characterization. Our key advantages include:
✔ Regulatory Expertise
Our testing fully complies with ISO 10993-18, FDA, and EU MDR requirements, ensuring seamless regulatory approval..
✔ Cutting-Edge Analytical Techniques
We employ UHPLC-HRMS, UPLC‑UV-MS, HPLC, LC-MS, and gravimetric analysis for the most accurate and reliable results.
✔ Customized Testing Solutions
We tailor extraction methods and analytical approaches based on device materials, intended use, and regulatory needs.
✔ Fast Turnaround & Comprehensive Reporting
Our streamlined process delivers detailed, actionable data to accelerate regulatory submissions.
✔ End-to-End Support
From material screening to biocompatibility assessments, we provide a full range of testing services to ensure device safety and compliance.
By partnering with Meditronics for NVOC testing, medical device manufacturers can enhance product safety, reduce regulatory risks, and accelerate market entry. Contact us today to learn how we can support your chemical characterization needs.
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