Chemical Degradation Studies: Assessing Long-Term Stability
Medical devices intended for permanent or prolonged contact must be evaluated for their potential to degrade in the physiological environment. Chemical degradation studies identify the products released as a material breaks down, ensuring that these byproducts do not cause local or systemic toxicity.
EBI provides specialized degradation protocols tailored to polymers.
Why Assess Chemical Degradation?
A device may be biocompatible in its initial state, but its degradation products might not be. Evaluation is required in the following scenarios:
- Non-resorbable Polymers: For long-term implants (remaining in the body for more than 30 days) or where there is a risk of corrosion or mechanical wear, assessment is conducted according to ISO 10993-13.
- Resorbable or Bioabsorbable Devices: As ISO 10993-13 specifically covers non-resorbable polymers, resorbable devices require a customized, individual approach. At EBI, we design specialized degradation studies tailored to the specific metabolic pathways and absorption profile of your material.
Methodology: Material-Specific Testing
We follow the specific parts of the ISO 10993 series based on your device material:
- Polymeric Devices (ISO 10993-13): We use real-time or/and accelerated aging tests to identify degradation products resulting from hydrolysis or oxidative stress.
Technical Requirements and Timing
- Sample Requirements: To be determined based on device surface area and degradation rate; typically requires multiple time points.
- Standard Turnaround Time: Highly variable, ranging from few weeks (accelerated) to several months (real-time studies).
Compliance
- ISO 10993-13/14/15: Material-specific degradation standards.
- ISO 10993-9: Framework for identification and quantification of potential degradation products.
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.
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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