Biocompatibility studies are fundamental to ensure the safety of Medical 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
- 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.
- 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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