Buehler Sensitization
1. Biological Effect: Sensitization
2. Turnaround time: 12 weeks
3. Sample Requirements:
ISO
120 pieces of 2.5 cm x 2.5 cm patches each;
4. Animal Quantity: 20 or 35 guinea pigs
ISO 10993-10
The purpose of the study is to determine the sensitizing capacity or allergenic potential of the medical device in guinea pigs. The test item is exposed to the assay system by direct application. In the “induction phase” the medical is applied topically to the skin as closed patches, for 3 exposures per 1 week for 3 weeks. 14 days after the induction phase, the challenge assay will be performed by the application of an assay patch to new sites and observed for edema and erythema at 24 and 48 hours. A sensitization reaction to the medical device (or extract) is scored based on the defined evaluation criteria in ISO 10993-10.
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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