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iso-10993-3-genotoxicity-testing-of-medical-materials
Chemical Resistance and Material Compatibility Testing ASTM D130 Copper Corrosion TestingASTM D130 Corrosion Testing of MetalsASTM D2240 Hardness Testing of Polymer MaterialsASTM D2240 Hardness Testing Post Chemical ExposureASTM D256 Impact Resistance After Chemical ExposureASTM D257 Electrical Resistivity Post Chemical ExposureASTM D2765 Thermal Analysis After Chemical ExposureASTM D3359 Adhesion of Coatings Post Chemical ExposureASTM D3359 Adhesion Testing After Chemical ExposureASTM D3762 Abrasion Resistance Post Chemical ExposureASTM D3985 Oxygen Transmission Rate After Chemical ExposureASTM D4216 Chemical Resistance of PolypropyleneASTM D471 Swelling Resistance in LiquidsASTM D4727 Resistance of Rubber to ChemicalsASTM D522 Flexibility Post Chemical ExposureASTM D543 Chemical Resistance of PlasticsASTM D543 Resistance of Plastics to Chemical ReagentsASTM D543-14 Chemical Resistance of Plastics and ElastomersASTM D570 Water Absorption of PlasticsASTM D570 Water Absorption of Polymer SamplesASTM D638 Tensile Properties After Chemical TreatmentASTM D638 Tensile Testing of Chemical-Exposed SamplesASTM D638 Tensile Testing Post Chemical ExposureASTM D648 Heat Deflection Temperature After Chemical ExposureASTM D7338 Chemical Resistance of PolyethyleneASTM D746 Low Temperature Impact Post Chemical ExposureASTM D7569 Resistance to Chemical ExposureASTM D792 Density of Plastics After Chemical ExposureASTM D882 Tensile Properties of Thin Plastic SheetingASTM E96 Water Vapor Transmission Post Chemical ExposureASTM F1515 Chemical Resistance of Medical PlasticsASTM F1522 Resistance to Chemicals in Medical DevicesASTM F1874 Chemical Resistance of ElastomersASTM F2026 Chemical Resistance of Polymeric MaterialsASTM F2028 Chemical Compatibility of Surgical InstrumentsASTM F2033 Chemical Resistance of Medical PolymersASTM F2299 Resistance to Bacterial PenetrationASTM F2397 Chemical Resistance of ElastomersASTM F739 Chemical Permeation TestingASTM F748 Resistance of Polymers to ChemicalsASTM F903 Liquid Penetration ResistanceASTM F904 Chemical Resistance of Polymers in Medical UseISO 10993-1 Biological Evaluation ProcessISO 10993-10 Biological Evaluation of MaterialsISO 10993-10 Irritation Testing Post Chemical ExposureISO 10993-11 Cytotoxicity Testing Post Chemical ExposureISO 10993-12 Chemical Resistance Sample PreparationISO 10993-13 Extraction Methods for Medical DevicesISO 10993-14 Degradation Products in Medical MaterialsISO 10993-15 Identification of Degradation ProductsISO 10993-16 Toxicokinetics of MaterialsISO 10993-17 Toxicological Risk AssessmentISO 10993-18 Chemical Characterization of Medical DevicesISO 10993-19 Chemical Characterization for Medical DevicesISO 10993-2 Animal Welfare Requirements in TestingISO 10993-20 Sensitization TestingISO 10993-21 Evaluation of Degradation ProductsISO 10993-22 Evaluation of Material InteractionISO 10993-23 Assessment of ToxicityISO 10993-24 Evaluation of Extractables and LeachablesISO 10993-25 Material Compatibility ValidationISO 10993-26 Chronic Toxicity TestingISO 10993-27 Immunotoxicology TestingISO 10993-28 Mutagenicity TestingISO 10993-29 Chemical Residue LimitsISO 10993-30 Toxicological Risk AssessmentISO 10993-4 Blood Compatibility TestingISO 10993-4 Hemocompatibility TestingISO 10993-5 In Vitro CytotoxicityISO 10993-6 Local Effects after Chemical ExposureISO 10993-7 Ethylene Oxide Residue LimitsISO 10993-8 Material Compatibility with BloodISO 10993-9 Selection of Tests for Medical MaterialsISO 11135 Material Compatibility in EO SterilizationISO 11135-1 EO Sterilization Material CompatibilityISO 11135-2 EO Sterilization Effects on MaterialsISO 11137 Chemical Resistance of Sterilized DevicesISO 11607 Material Compatibility with SterilizationISO 13485 Material Compatibility RequirementsISO 14644-1 Cleanroom Material CompatibilityISO 14644-3 Cleanroom Material CompatibilityISO 22442 Compatibility of Implants with Biological SystemsISO 22442-2 Biocompatibility TestingISO 22442-3 Evaluation of Material Safety

Comprehensive Guide to ISO 10993-3 Genotoxicity Testing of Medical Materials Laboratory Testing Service Provided by Eurolab

ISO 10993-3:2006 is an international standard that specifies the tests for the evaluation of genotoxicity, a key aspect of the biocompatibility testing of medical devices. Genotoxicity refers to the potential of a substance or material to cause genetic damage, which can lead to mutations and cancer in living organisms.

Relevant Standards

  • ISO 10993-3:2006

  • ASTM E2598-07 (Standard Guide for Evaluating Genotoxicity)

  • EN ISO 10993-3:2006

  • TSE LMD-01 (Turkish Standard for Medical Device Testing)

    • International and National Standards

    ISO 10993-3 is an international standard developed by the International Organization for Standardization (ISO) to ensure that medical devices are safe and effective. The standard is widely recognized and adopted by regulatory agencies around the world, including the US FDA, EU Notified Bodies, and others.

    Standard Development Organizations

    The ISO 10993 committee, comprising experts from various industries and countries, develops and updates standards for biocompatibility testing of medical devices. Other organizations, such as ASTM International (formerly known as American Society for Testing and Materials) and EN (European Committee for Standardization), also contribute to the development of related standards.

    Evolution of Standards

    Standards evolve over time in response to advances in technology, new scientific discoveries, and changes in regulatory requirements. The ISO 10993-3 standard has undergone several revisions since its initial publication in 1992.

    Standard Numbers and Scope

  • ISO 10993-1:2009 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process)

  • ISO 10993-2:2010 (Biological evaluation of medical devices Part 2: Animal welfare requirements)

  • ISO 10993-3:2006 (Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity)

    • Standard Compliance Requirements

    Medical device manufacturers must comply with relevant standards to ensure the safety and effectiveness of their products. This includes adhering to the requirements outlined in ISO 10993-1, which emphasizes risk management and biocompatibility testing.

    Industry-Specific Examples and Case Studies

    The genotoxicity testing requirements for medical devices vary depending on the device type and intended use. For example:

  • Implantable devices, such as pacemakers or joint replacements, require more stringent testing due to their direct contact with tissue.

  • Medical devices that come into contact with blood, such as dialyzers or infusion sets, also require rigorous testing.

    • Consequences of Non-Compliance

    Failure to comply with ISO 10993-3 and other relevant standards can lead to regulatory non-compliance, product recalls, and damage to a companys reputation.

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