✅ Summary – Key Points at a Glance
- The difference between extractables vs leachables in medical devices lies in how compounds migrate from materials into patients or environments.
- Extractables are chemicals released under exaggerated lab conditions; leachables are substances that migrate under real-world use.
- Understanding both is crucial for patient safety, regulatory compliance, and device approval.
- Proper E&L testing ensures material compatibility, risk mitigation, and regulatory success.
- ResolveMass Laboratories offers customized EL testing, backed by ISO 10993-18 protocols and cutting-edge analytical expertise.
- Learn about costs, checklists, compliance case studies, and more via ResolveMass Labs’ complete EL services.
🔍 Introduction to Extractables vs Leachables in Medical Devices
Knowing the difference between extractables and leachables in medical devices is essential for product designers, quality teams, and regulatory professionals. It helps prevent costly product recalls, speeds up regulatory review, and ensures safer devices for patients.
Both extractables and leachables tests tell us how materials react in different situations. These tests are often required to prove that a device is safe and won’t release harmful chemicals during use. At ResolveMass Laboratories, we specialize in complete E&L testing programs that deliver high-quality results.
We combine regulatory knowledge with technical skills to support product development from early design to final approval.
🔬 What Are Extractables?
Extractables are chemicals that can be pulled out from a medical device’s materials when the product is exposed to extreme lab conditions. This might include high temperatures, strong solvents, or other stress factors that don’t usually happen in normal use but help simulate the worst-case scenario.
| Parameter | Extractables |
|---|---|
| Test Conditions | Simulated (exaggerated) lab settings |
| Purpose | Identify all potential leachable risks |
| Analytical Techniques | GC-MS, LC-MS, ICP-MS, FTIR, etc. |
| Compliance Standards | ISO 10993-18, USP <1663> |
| Testing Stage | Early-stage risk assessment |
By identifying extractables early, manufacturers can manage risks and change materials or designs before going too far in the product lifecycle. It’s a smart step to protect users and meet safety rules.
Learn more about USP Extractables & Leachables testing protocols at ResolveMass.
💧 What Are Leachables?
Leachables are chemicals that actually migrate from a medical device into the drug, patient, or environment during real use. Unlike extractables, these are tested under conditions that closely match how the device will be used or stored.
| Parameter | Leachables |
|---|---|
| Test Conditions | Realistic (clinical, storage use) |
| Purpose | Confirm exposure under intended use |
| Analytical Techniques | Targeted analysis, stability testing |
| Compliance Standards | ISO 10993-17, USP <1664> |
| Testing Stage | Final validation and approval |
Leachables data is crucial for toxicology reviews and final regulatory submissions. It directly proves that the product is safe under expected usage conditions.
For detailed guidance, see our E&L Testing for Medical Devices page.
🎯 Extractables vs Leachables in Medical Devices: Key Differences
| Feature | Extractables | Leachables |
|---|---|---|
| Purpose | Find possible risks | Confirm actual exposure |
| Timing | Early development stage | Final product validation |
| Test Conditions | Harsh lab conditions | Real-use or storage conditions |
| Risk Type | Potential risk | Actual risk |
| Regulatory Role | Supports design safety | Supports clinical and market approval |
Knowing these differences helps create a complete safety profile for your device. This is especially important for ISO 10993 compliance and successful global market approval.
Visit our Custom EL Testing Services to tailor solutions for your device.
✅ Why E&L Testing Is Important in Medical Devices
Extractables and leachables testing is required to prove that the materials used in a medical device are safe and compatible with the human body or drug product. Without proper E&L testing, you risk failing regulatory review or, worse, causing harm to users.
Here are some key reasons why this testing is vital:
- Ensures product safety and chemical compatibility
- Meets FDA, EU MDR, and Health Canada regulations
- Reduces the chance of recalls and adverse events
- Supports toxicology risk assessments with real data
- Required under ISO 10993-17 and 10993-18
A strong E&L program adds confidence to your device development process and regulatory submission.
Explore our full ISO 10993-18 EL Testing services for deep compliance.
Case Study: E&L Testing in a Class III Medical Device
ResolveMass Laboratories worked with a manufacturer of a Class III implantable device who was preparing for a pre-market review. During the E&L testing, we detected unexpected leachables that had not been identified in earlier studies.
Because of these findings, the company was able to revise their material choices and pass regulatory review without delays. This example shows how essential it is to perform deep and thorough extractables vs leachables testing in medical devices before launch.
💰 What Affects the Cost of E&L Testing?
The cost of extractables and leachables testing can vary based on a few important factors:
- Type and number of materials in the device
- Whether the device is Class I, II, or III
- Number of solvents or testing conditions used
- Complexity of lab methods (e.g., LC-MS, ICP-MS)
- Duration of testing (short-term vs long-term)
To help you estimate costs more accurately, ResolveMass offers a customized budgeting tool and project planning support.
Use our guide on Cost of E&L Testing to estimate your budget.
🔎 How ResolveMass Supports E&L Testing Programs
ResolveMass provides full-service support for extractables vs leachables in medical devices, offering tailored solutions that align with your regulatory and compliance goals. Our testing includes:
- Advanced instruments (GC-MS, LC-MS/MS, ICP-MS)
- Experts in toxicology and material science
- Support for FDA, EMA, and global filings
We understand the pressure of regulatory timelines and offer fast, precise solutions to help you succeed.
Check our CRO for E&L Testing capabilities to partner with a team that’s regulatory-ready.
🧪 Planning Your E&L Study? Here’s How to Start
Before starting E&L testing, it’s important to plan the process carefully. A strong plan will save time and avoid rework later.
Download our free E&L Testing Checklist, which includes:
- Material selection guidelines
- Required documents for submission
- Lab testing timelines and steps
- Safety and compliance checkpoints
Download our free E&L Testing Checklist for Medical Devices to prepare your study efficiently.
Final Thoughts: Why Extractables vs Leachables in Medical Devices Matter
Understanding extractables vs leachables in medical devices isn’t just about science—it’s about safety, compliance, and success. These tests help you:
- Protect patients from chemical risks
- Meet all global safety regulations
- Get your product to market faster
- Build a strong safety case for submission
Partner with ResolveMass Laboratories for expert guidance and proven testing solutions.
Need help? Start with our Do I Need E&L Testing? tool.
📞 Contact Us Today
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FAQs About Extractables vs Leachables in Medical Devices
Extractables are chemicals that come out of a medical device when it is tested under harsh lab conditions, like heat or strong solvents. Leachables, on the other hand, are chemicals that actually move into a drug or body during real-life use of the device. Extractables show potential risks, while leachables confirm real exposure.
The FDA follows guidance that requires medical devices, especially those in contact with the body or drugs, to be tested for extractables and leachables. These tests help ensure that harmful chemicals do not leach out during use. The goal is to prove that the device is safe and does not cause toxic effects.
The main ISO standards are ISO 10993-18 for extractables and ISO 10993-17 for leachables. ISO 10993-18 explains how to identify and study extractables in medical device materials. ISO 10993-17 focuses on how to evaluate the health risks from leachables that may reach the patient.
Extractables testing is usually done early, during the design or prototype stage. Leachables testing comes later, closer to the final product stage, to confirm real-world safety. Doing both at the right time helps avoid risks and delays.
A risk assessment looks at the amount of chemicals that could reach the patient and compares it to safe levels. This helps decide if the device is safe to use. It is a key step in proving product safety.
These tests are especially important for Class II and Class III medical devices, particularly if they contact the body or are used with drugs. Not all devices need testing, but many do to meet regulatory standards. It’s best to check based on device type.
