What does ISO 10993-18 chemical characterization mean in practice?
Chemical characterization under ISO 10993‑18 provides the analytical foundation for toxicological risk assessment. It determines which extractables and leachables a device may release and in what quantities. The standard outlines how to establish a complete constituents profile that feeds directly into ISO 10993‑17 toxicology and the ISO 10993‑1 Biological Evaluation.
Key components of characterization include suitable extraction approaches and a broad range of analytical methods. Depending on the substance class, GC-MS is used for volatile and semi-volatile organic compounds, LC-MS/MS for non-volatile organic compounds, and ICP-MS for elements and metals. Headspace analysis can also be useful for detecting extremely volatile substances. Together, these methods provide the most complete E&L profile possible. In addition to non-targeted screening approaches, target analyses can also be performed.
Extraction is designed risk‑based in alignment with ISO 10993‑12 but tailored to analytical needs: selection of relevant media, surface‑area‑to‑volume ratio, time–temperature conditions and artefact control. The goal is to simulate a realistic but analytically meaningful worst‑case scenario for chemical release.
The output is a comprehensive constituents list, including concentrations, limits of detection and quantification (LOD/LOQ) and full analytical documentation. This dataset feeds into ISO 10993‑17 toxicology, which evaluates exposure and compares it with toxicological reference values before integration into the overall ISO 10993‑1 Biological Evaluation.
Norm criteria – at a glance
| Normkriterium | Anforderung / Inhalt | Hinweis |
|---|---|---|
| Analytics | GC-MS | Volatile & semi-volatile organic compounds |
| Analytics | LC-MS/MS | Non-volatile organics |
| Analytics | ICP-MS | Elements/metals |
| Approach | Screening + target/non-target | Matrix-dependent |
| Output | Constituents list incl. LOD/LOQ & concentrations | Input for ISO 10993-17 |
How we test your medical device – step by step
- Request a quote by phone or online. Key inputs: device, materials/components, contact type and exposure duration, and the device condition (e.g., sterilized/reprocessed).
- Send your device after accepting the quote. Please provide the sample in the marketed/used state where possible (including reprocessed state if applicable).
- Upon receipt, we start testing and document sample logistics and—where relevant—ISO 10993-12 aligned preparation/extraction parameters.
- We coordinate with qualified partners an ISO 10993-18 extractables & leachables (E&L) profile using appropriate analytics (e.g., GC-MS, LC-MS/MS, ICP-MS) and provide a traceable constituents list supporting ISO 10993-17 toxicology.
- You receive a digital, QES-signed report with professional interpretation. Upon request, we coordinate next steps through external toxicology (ISO 10993-17) and the ISO 10993-1 Biological Evaluation.
Why HygCen?
- DAkkS accredited testing laboratory (DIN EN ISO/IEC 17025) with GLP-compliant processes.
- Risk-based study design aligned with intended contact type, duration and use.
- Testing in the original state, including relevant processing/sterilization/reprocessing influences.
- Digital, QES-signed report with expert interpretation for MDR technical documentation.
- One-stop coordination: we manage the full process—from ISO 10993-18 data to external ISO 10993-17 toxicology and ISO 10993-1 Biological Evaluation.
Extractables refer to constituents released under exaggerated laboratory conditions, such as elevated temperatures or aggressive media. Leachables are substances that actually migrate under realistic clinical exposure. Extractables help identify the full chemical universe; leachables define what truly matters toxicologically. Both are essential components of ISO 10993‑17.
GC‑MS is ideal for volatile and semi‑volatile compounds, while LC‑MS/MS detects non‑volatile, polar or thermally unstable substances. ICP‑MS adds coverage of elemental constituents. Together, these methods provide a comprehensive chemical and toxicological profile for regulatory review.
Extraction design follows ISO 10993‑12 but with an analytical emphasis: media selection, time–temperature settings and surface‑area‑to‑volume ratios are defined risk‑based. The aim is to generate a meaningful worst‑case scenario without creating artificial artefacts. All settings are described and justified in the study documentation.
A complete constituents list including concentrations, LOD/LOQ, analytical parameters and quality controls. Methods used (GC‑MS, LC‑MS/MS, ICP‑MS) and the full study design are documented for traceability and regulatory acceptance. This dataset supports downstream toxicological evaluation under ISO 10993‑17 and integration into BEP and BER.
The generated chemical data form the basis for ISO 10993‑17 exposure and risk calculation. These results are then integrated into ISO 10993‑1 Biological Evaluation to combine chemical, biological and clinical evidence into a coherent safety conclusion. A consistent 10993‑18 → 10993‑17 → 10993‑1 chain is essential for regulatory acceptance.
Related links
ISO 10993-12 – Sample preparation & reference materials, ISO 10993-10 – Skin sensitization, ISO 10993-5 – Cytotoxicity, ISO 10993-23 – Irritation, ISO 10993-3 – Genotoxicity, ISO 10993-4 – Hemocompatibility, Pyrogenicity & endotoxin – incl. ISO 10993-11 coordination, ISO 10993-1 – Biological Evaluation