Welcome to  
EUROPEAN  
BIOMEDICAL  
INSTITUTE

Offer

Biocompatibility

The concept of biocompatibility refers to the interaction between the tissues and the physiological systems of a patient treated with a medical device. The biocompatibility assessment is part of the overall device safety assessment.

Extractables & Leachables

Extractables and Leachables Testing is an analysis of potentially harmful materials that could be administered to a patient with a drug or device. Toxicological assessments may then be made, to quantify a patient’s exposure to each chemical and gauge the level of risk posed by these materials.

Biological reactivity USP

Biological reactivity tests of elastomerics, plastics and other polymeric materials that have direct or indirect contact with the patient were designed to determine the biological in vitro , in vivo response. Based on different plastics class various tests need to be conducted according to Table 1: Classification of Plastics of USP <88> , USP <87>.

Other Services

We offer pre-clinical testing and consulting services of medical devices. We have our own laboratories that are among some of the most modern in all of Europe and we are proud to say we have a very broad field of tests we are able to conduct.

ABOUT US

European Biomedical Institute

We are specialized in comprehensive biocompatibility testing according to the all series of ISO 10993 biological evaluation of medical devices – but not only! We are constantly developing our labs to offer more services for your medical devices:

  • Microbiology and sterility testing
  • Package validation
  • Reprocessing validation
  • Consulting services

LATEST

NEWS

A Culture Of Quality

Each professional laboratory should have an own developed work system. This system should be based on both written and unwritten rules that the laboratory encourages its employees to follow them. The development of the quality system, with the underlying...

read more

XTT Cytotoxicity

1. Biological Effect: Cytotoxicity Tests 2. Sample Requirements ISO 120 cm^2 (test item < 0.5 mm thick);60 cm^2 (test item ≥ 0.5 mm thick);4 grams;5 mL 3. Turnaround time: 4 weeks ISO 10993-5 The purpose of the study is to determine the potential biological...

read more

MTT Cytotoxicity

MTT Cytotoxicity Biological Effect:    Cytotoxicity Tests   Turnaround time:    4 weeks   Sample Requirements:    ISO        120 cm2 (test item < 0.5 mm thick); 60 cm2 (test item ≥ 0.5 mm thick); 4 grams; 5 mL;   ISO 10993-5 The purpose of the study...

read more

MEM Elution

1. Biological Effect: Cytotoxicity Tests 2. Sample Requirements ISO 120 cm^2 (test item < 0.5 mm thick);60 cm^2 (test item ≥ 0.5 mm thick);4 grams;5 mL 3. Turnaround time: 4 weeks ISO 10993-5 The purpose of the study is to determine the potential biological...

read more

International Women’s Day in Engineering!

Today is International Women’s Day in Engineering! At European Biomedical Institute, we break the stereotype of male-dominated engineering environment. Why is it worth becoming an engineer.  This question is answered by Ilona, Kamila and Justyna. Check this out:...

read more

Our Customer successfully registered his product in CFDA!

Our Customer successfully registered his product in CFDA! We are proud to inform, that our Customer successfully registered his product in CFDA (Chinese Food and Drug Administration) based on European Biomedical Institute reports and support!The chemical...

read more

Irritation or Intracutaneous

  Irritation or Intracutaneous reactivity   Did you know that Irritation or Intracutaneous reactivity is one of two in vivo biological endpoints to be evaluated of a medical device according to the ISO 10993-1:2018 ? In accordance with the ISO 10993-10, we...

read more

The sensitization test

  The sensitization test The sensitization test is the second, except for the irritation test, in vivo biological endpoint to be evaluated any type of medical device required by ISO 10993-1: 2018. In ISO 10993-10 three types of sensitization tests are mentioned:...

read more

European Biomedical Institute profile

We always pay attention to our Customers needs. From the begging of our history till today, our aim is to offer the highest quality of tests with the shortest possible lead time in a cost effective manner. This is our DNA.

 

CERTIFICATES

Our certificates

Good Laboratory Practice (GLP). Quality system implemented by European Biomedical Institute. It defines a set of rules and criteria for studies that are planned, performed and monitored, and their results are recorded, reported and archived. It is possible to trace the course of the study or its complete reconstruction. European Biomedical Institute is GLP certified.

ISO 17025 – The quality management standard, implemented to standardize the technical requirements and requirements of management system, intended for research laboratories. Our management system is based on the ISO 17025 standard. European Biomedical Institute is ISO 17025 accredited.