Degradation Testing (ISO 10993-9)
Understand the long-term stability of your materials. Our degradation studies identify, quantify, and characterize the breakdown products of medical devices to ensure they remain safe throughout their entire lifecycle.
Degradation testing is a vital component of biological evaluation, particularly for devices intended for long-term or permanent contact with the body. Over time, physiological environments can cause materials to break down, releasing degradation products that may elicit different biological responses than the parent material. At EBI, we provide comprehensive in vitro and in vivo assessments to predict and analyze these changes according to the ISO 10993 series.
Why Is Degradation Testing Required?
Regulatory bodies (MDR, FDA) require a degradation assessment to ensure that:
- By-products are Non-Toxic: Degradation products must not cause local irritation, systemic toxicity, or carcinogenicity.
- Mechanical Integrity: The device must maintain its intended function until it is no longer required (especially critical for absorbable implants).
- Clear Clearance Pathways: We identify how the body metabolizes and excretes the broken-down materials.
Our Tiered Testing Framework
We follow the systematic approach outlined in ISO 10993-9 to assess polymers, metals, and ceramics.
1. In Vitro Degradation Studies
This is the first and often most critical step. We simulate the physiological environment to observe material breakdown without animal testing.
- Standard Degradation (ISO 10993-13/14/15): Samples are placed in simulated body fluids (SBF) at 37°C.
- Accelerated Degradation: To predict years of breakdown in a shorter timeframe, we utilize elevated temperatures and varying pH levels.
- Real-Time Stability: Long-term studies conducted under physiological conditions to confirm real-world performance.
2. Chemical Characterization of By-products
Once degradation occurs, we use high-resolution analytical tools (LC-MS, GC-MS, ICP-MS) to:
- Identify the chemical structure of all degradation products.
- Quantify the rate of release.
- Assess the morphology of the remaining material via SEM (Scanning Electron Microscopy).
3. In Vivo Degradation Assessment
For absorbable devices or when in vitro data is insufficient, we conduct in vivo studies.
- Objective: To monitor the material’s breakdown within a biological system, including tissue integration and the localized metabolic response.
- Histopathology: Expert analysis of the surrounding tissue to ensure the degradation process does not trigger an adverse inflammatory or fibrotic response.
Material-Specific Standards
EBI provides specialized testing protocols tailored to your device’s composition:
- ISO 10993-13: Identification and quantification of degradation products from polymeric medical devices.
- ISO 10993-14: Identification and quantification of degradation products from ceramics.
- ISO 10993-15: Identification and quantification of degradation products from metals and alloys.
Sample Requirements & Timeline
- Turnaround Time: Dependent on the study design (ranging from 4 weeks for initial screens to several months for long-term stability).
- Sample Preparation: Devices should be in their final, sterilized state.
- Study Design: We provide custom protocols based on the expected degradation rate of your specific material.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Frequently Asked Questions
Do all medical devices need degradation testing?
Testing is typically required if the device is intended to be resorbed by the body, or if there is a risk that the device may degrade over its period of use due to its material composition and the nature of body contact.
What is an „Absorbable” or „Resorbable” device?
These are devices (like sutures, bone screws, or stents) designed to provide temporary support and then safely break down and be absorbed by the human body, eliminating the need for a second surgery to remove the implant.
How do you simulate the body environment?
We use various buffers and simulated fluids (e.g., Simulated Lung Fluid, Synthetic Saliva, or Phosphate Buffered Saline) and can adjust the pH to simulate specific conditions, such as the acidity found in an inflammatory site or the stomach.
Do all medical devices need degradation testing?
Testing is typically required if the device is intended to be resorbed by the body, or if there is a risk that the device may degrade over its period of use due to its material composition and the nature of body contact.
What is an "Absorbable" or "Resorbable" device?
These are devices (like sutures, bone screws, or stents) designed to provide temporary support and then safely break down and be absorbed by the human body, eliminating the need for a second surgery to remove the implant.
How do you simulate the body environment?
We use various buffers and simulated fluids (e.g., Simulated Lung Fluid, Synthetic Saliva, or Phosphate Buffered Saline) and can adjust the pH to simulate specific conditions, such as the acidity found in an inflammatory site or the stomach.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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