Peel Testing
Peel Testing is a critical quality control and performance validation method for medical devices that rely on adhesive bonding or layered material structures. Devices such as wound dressings, surgical tapes, transdermal patches, electrode adhesives, and sterile packaging seals must undergo peel strength testing to ensure regulatory compliance, patient safety, and functional reliability.
Regulatory bodies like the FDA (21 CFR Part 820), EU MDR, and ISO 13485 require manufacturers to validate adhesive performance to prevent failures that could lead to infection risks, improper wound closure, or device detachment. Peel testing evaluates:
- Adhesive strength – Ensures medical tapes and patches remain securely attached under physiological conditions.
- Material integrity – Verifies that layered structures (e.g., films, foams, and backings) do not delaminate prematurely.
- Packaging reliability – Confirms sterile barrier seals maintain integrity during transport and handling.
Our Service
At Meditronics (a brand of STEMart), we provide fully compliant Peel Testing services in accordance with ASTM, ISO, and other international standards, including:
-
180° Peel Strength Test (ASTM D903 / ISO 8510-1)
Method: A bonded sample is peeled at a 180° angle from a rigid substrate at a controlled speed.
Applications:- Medical adhesive tapes (e.g., ECG electrodes, wound closure strips).
- Transdermal drug delivery patches.
- Flexible packaging seals (e.g., sterile barrier pouches).
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T-Peel Test (ASTM D1876 / ISO 11339)
Method: Two flexible bonded substrates are pulled apart in a T-shaped configuration to measure interfacial adhesion.
Applications:- Multi-layer wound dressings and foam-based medical products.
- Laminated films in sterile packaging.
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90° Peel Strength Test (ASTM F2256)
Method: The adhesive-coated material is peeled at a 90° angle, simulating real-world detachment forces.
Applications:- Pressure-sensitive adhesives (PSAs) for medical devices.
- Skin-contact adhesives requiring controlled release.
Additionally, we perform customized peel testing for unique device configurations, ensuring accurate and reproducible results.
Why Choose Meditronics?
Meditronics is a trusted partner for medical device manufacturers seeking reliable, regulatory-compliant peel testing services. Our key advantages include:
✔ Regulatory Expertise
Our team deeply understands FDA, EU MDR, and ISO 13485 requirements, ensuring your testing aligns with global standards.
✔ State-of-the-Art Equipment
Our Peel Testing services are supported by state-of-the-art tensile testing systems equipped with high-sensitivity load cells and precision grips to ensure reliable adhesion measurements.
✔ Broad Testing Capabilities
We support all medical devices requiring Peel Testing, from small adhesive samples to large-scale packaging validations.
✔ Fast & Compliant Reporting
Detailed test reports with traceable data, compliance statements, and expert recommendations for product improvement.
Whether you are developing new medical adhesives, validating packaging seals, or ensuring adhesive performance in clinical use, Meditronics delivers fast, accurate, and regulatory-ready peel testing solutions.
Contact us today to discuss your testing needs and ensure your medical devices meet the highest quality and safety standards!
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