BIO COMPATIBILITY TESTS

We provide a wide variety of material evaluations using in vivo / in vitro test methods for Pharmaceuticals, Medical Devices, Cosmetics and Medical Products.

All experiments are carried out according to the current / valid best laboratory / quality practices, and we offer compatible tests at National and International legal authorities.

*These studies are carried out and carried out within the scope of National and International standards, with personnel who adhere to the principles of impartiality and confidentiality, have the necessary training, understand the documentation and customer demands.

Our animal programs are approved by Akdeniz University HADYEK Ethics Committee.

It is considered that suitably validated, reliable and adaptable in vitro test methods are preferably used prior to in vivo experiments.

Our test results are compared between laboratories within the scope of ISO 17043, which is reproducible.

We combine our technical and analysis expertise with legal requirements in a tailored approach to our customers.

Biocompatibility Testing Services (ISO, OECD, ASTM, EN)

In Vitro Cytotoxicity Test EN ISO 10993-5;2009

In Vivo Skin Irritation Test EN ISO 10993-23;2021

In Vivo Vaginal Irritation Test EN ISO 10993-23

In Vivo Rectal Irritation Test EN ISO 10993-23

In Vivo Acute Ocular Irritation EN ISO 10993-23

In Vivo Oral Mucosa Irritation Test EN ISO 10993-23

In Vivo Sensitivity Test EN ISO 10993-10;2021

Guinea Pig Max. Sensitivity Test OECD 406

In Vitro EpiDerm Skin Corrosion Test OECD 431

Acute Dermal (Irritation/Corrosion) Irritation OECD 404

In Vitro EpiDerm Skin Irritation Test OECD 439

Intraocular Irritation ISO 15798:2013

Implantation Test Subcutaneous- Subcutaneous Annex-A EN ISO 10993-6;2016

Implantation Test Muscle Tissue Annex-B EN ISO 10993-6;2016

Implantation Test Intraosseous Annex-C EN ISO 10993-6;2016

Acute Systemic Toxicity Test EN ISO 10993-11;2017

Subacute Systemic Toxicity Test EN ISO 10993-11;2017

Subchronic Systemic Toxicity Test EN ISO 10993-11;2017

Chronic Toxicity Test (6 Months-12 Months) EN ISO 10993-11;2017

Genotoxicity Micronucleus Test OECD 487;2016

Genotoxicity Comet Test OECD 489

Genotoxicity Gene Mutation Test OECD 476;2016

Genotoxicity AMES Test OECD 471;1997

Genotoxicity Chromosomal Aberration Test OECD 473;1997

In Vivo/In Vitro Hemolytic Effect Test (Hemolysis) EN ISO 10993-4;2017

Pyrogenicity Test (In Vivo) EN ISO 10993-11;2018

Carcinogenicity Test EN ISO 10993-3/OECD 453

Ethylene Oxide Sterilization Residues ISO 10993-7;2008

Potential degradation, identification and quantification ISO 10993-9;2019

Polymeric Medical Devices ISO 10993-13;2010

Ceramic Medical Devices ISO 10993-14;2001

Metals and Alloys Medical Devices ISO 10993-15;2019

Toxicokinetic study design ISO 10993-16;2017

Leachable Substances ISO 10993-17;2002

Chemical Characterization ISO 10993-18;2020

Mouse Embryo Test (MEA)

Bioburden Test “USP61” ISO 11737-1;2018

Sterility Test “USP71” ISO 11737-2;2019

Bacterial Endotoxin Test ISO 11737-3 (Under Development)

Monocyte Activation Test (MAT) (Under Development)

Stability Test ASTM F1980 Packaging Strength Test TS EN 868-5

Packaging Leak Test ASTM F1929

Linear Measurement with Precision Steel Ruler ASTM F2203

Biological Evaluation of Medical Devices, Part 1; ISO 10993-1:2021

Biological Evaluation of Medical Devices, Part 2; ISO 10993-2:2006

Biological Evaluation of Medical Devices, Part 3; ISO 10993-3:2014

Biological Evaluation of Medical Devices, Chapter 12; ISO 10993-12:2021

Standards Applied

National and International Standards;

  • TSE - Turkish Standards Institute
  • EN - European Standards
  • ISO - International Standards Organization
  • ASTM - International American Society for Testing and Materials
  • OECD - Organization for Economic Co-operation and Development
  • USP - American Pharmacopoeia
  • AAMI - Association for the Development of Medical Instrumentation
  • AAALAC - International Association for Laboratory Animal Care Evaluation and Accreditation

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