Perform your biological evaluation with White Lab to ensure the safety of your Medical Device.Our biocompatibility studies are carried out in line with the Good Laboratory Practices (GLP ) and ISO 10993, USP, ASTM, and OECD international standards.
A highly-trained team that is always up to date supports the customer in choosing the most appropriate tests and how to carry out them depending on the device or material to test by drafting Rationales and Operating Protocols.
Biocompatibility studies are fundamental to ensure the safety ofMedical Devices. Indeed, thanks to the characterisation of the physical, chemical, and biological response of the product, they aim at highlighting all the potential and foreseeable toxic, physiological, immunogenic or mutagenic risks for human use.
The evaluation of biological safety is part of the general safety and performance requirements for Medical Devices set out in Regulation (EU) No 2017/745 (MDR) and for in-vitro diagnostic medical devices in Regulation (EU) No 2017/746 (IVDR).
During the design phase of the Medical Device, it is therefore essential to devise an appropriate testing strategy for biological evaluation based on the chemical and physical structure of component materials (type of Medical Device), the types of the patient's tissue that will be in contact with the device (invasiveness) and the exposure time (duration).
The reference standards are the ISO 10993 series, the United States Pharmacopoeia (USP), the American Society for Testing and Materials (ASTM) and the OECD series.
Specifically, UNI EN ISO 10993-1:2021 standard describes:
The general principles governing the biological evaluation of medical devices within a risk management process
The general categorisation of medical devices based on the nature and duration of their contact with the body
The evaluation of existing relevant data from all sources
The identification of gaps in the available data set on the basis of a risk analysis
The identification of additional data sets necessary to analyse the biological safety of the medical devices
The assessment of the biological safety of the medical devices
THE OTHER SECTIONS AND CHAPTERS OF THE STANDARD INCLUDE:
Section 1: Evaluation and testing
Chapter 2: Animal welfare requirements
Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Section 4: Selection of tests for interactions with blood
Section 5: Tests for in-vitro cytotoxicity
Part 6: Tests for local effects after implantation
Section 7: Ethylene oxide sterilization residuals
Section 8: Selection and characteristics of reference materials for biological testing
Chapter 9: Framework for identification and quantification of potential degradation products
Section 10: Tests for irritation and skin sensitization
Section 11: Tests for systemic toxicity
Section 12: Sample preparation and reference materials
Chapter 13: Identification and quantification of degradation products from polymeric medical devices
Chapter 14: Identification and quantification of degradation products from ceramics
Chapter 15: Identification and quantification of degradation products from metals and alloys
Chapter 16: Toxicokinetic study design for degradation products and leachables
Section 17: Establishment of allowable limits for leachable substances
Section 18: Chemical characterisation of materials
Section 23: Tests for irritation
White Lab Laboratories are certified as Test Facility operating in line with the Good Laboratory Practices (GLP) for biocompatibility testing.
Our in-vivo and in-vitro biocompatibility testing offer includes
Cytotoxicity testing: MEM Elution, MTT, agar diffusion, direct contact
Allergic skin sensitisation testing
Skin and mucosal irritation testing
Intracutaneous reactivity testing
Ocular, vaginal, anal, and penis mucous-irritation testing
Intramuscular, subcutaneous, and bone implantation testing
Acute, subacute. and subchronic systemic toxicity testing
Pyrogenicity testing on rabbits
Monocyte activation testing (Ph. Eu. 2.6.30)
Mutagenicity testing: Ames test for the study of bacterial reverse mutation
MLA genotoxicity testing: Mouse Lymphoma Assay Gene Mutation Test
Direct and indirect hemolysis testing
Hemocompatibility testing
Platelets count
Identification of blood corpuscular elements: count of red blood cells, white blood cells (CBC), platelets, and lymphocytes
SC5b complement activation (immunoassay)
Identification of plasma fibrinogen
Identification of non-activated PTT (non-activated partial thromboplastin time, thrombogenicity, b-TG platelet activation and TATC (Thrombin/Antithrombin test)
Evaluation of leachables in line with ISO 10993-17 standard ‘Establishment of allowable limits for leachable substances’
Chemical characterisation in line with ISO 10993-18 standard
Chemical characterisation in line with ISO 18562 series standard
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