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iso-10993-30-toxicological-risk-assessment
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 10993-3 Genotoxicity Testing of Medical MaterialsISO 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

Complete Guide to ISO 10993-30 Toxicological Risk Assessment Testing Services Provided by Eurolab

ISO 10993-30 is a standard developed by the International Organization for Standardization (ISO) that outlines the requirements for toxicological risk assessment testing of medical devices and materials. This standard is part of the ISO 10993 series, which covers various aspects of biocompatibility testing.

1.1 Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-30 testing is governed by international and national standards. The key regulations include:

  • ISO 10993-30:2018

  • ASTM F739-18 (Standard Test Method for Permeation of Liquids Through Protective Clothing)

  • EN 14325:2003 (Protective clothing against liquid chemicals - Laboratory test method)

  • TSE (Turkish Standards Institution) equivalent standards

    • 1.2 Standard Development Organizations and Their Role

    The ISO is a non-governmental organization that develops voluntary international standards. The development of standards is done through consensus among experts from various countries. Other standard development organizations include:

  • ASTM International

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • 1.3 Standard Evolution and Updates

    Standards are continuously updated to reflect the latest scientific knowledge and regulatory requirements. ISO 10993-30, for example, was revised in 2018 to incorporate new testing methods and requirements.

    1.4 Industry-Specific Compliance Requirements

    Compliance with ISO 10993-30 is mandatory for various industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Cosmetics and personal care product manufacturers

    • The purpose of ISO 10993-30 testing is to evaluate the potential toxicity of medical devices and materials. This test assesses the risk of adverse reactions in humans, including skin irritation, eye irritation, and systemic toxicity.

    2.1 Business and Technical Reasons for Conducting Testing

    Conducting ISO 10993-30 testing ensures compliance with regulatory requirements, reduces liability, and improves product safety. Non-compliance can result in financial penalties, product recalls, and damage to reputation.

    2.2 Consequences of Not Performing the Test

    Failure to conduct ISO 10993-30 testing can lead to:

  • Product recall

  • Financial penalties

  • Damage to reputation

  • Inability to access international markets

    • 2.3 Industries and Sectors Requiring This Testing

    The following industries require ISO 10993-30 testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Cosmetics and personal care product manufacturers

  • Biotechnology companies

    • 2.4 Risk Factors and Safety Implications

    ISO 10993-30 testing assesses the risk of adverse reactions in humans, including skin irritation, eye irritation, and systemic toxicity.

    The ISO 10993-30 test involves a series of steps:

  • Step 1: Sample Preparation

    • Sampling methods: selection of materials, sample size, and preparation.

    Equipment used: sampling tools, such as punches or cutting dies.

  • Step 2: Testing Parameters and Conditions

    • Temperature (37C 2C)

    Relative humidity (50 20)

    Light exposure (no direct sunlight)

    Sample size (typically 1 cm²)

  • Step 3: Measurement and Analysis Methods

    • Spectrophotometry

    Chromatography

    Mass spectrometry

  • Step 4: Data Collection and Recording Procedures

    • Data collection software

    Data recording methods: manual or automated

  • Step 5: Test Reporting and Documentation

    • The ISO 10993-30 test report includes:

  • Summary of Results: brief summary of the testing results.

  • Detailed Results: detailed results, including data tables and graphs.

  • Conclusions: conclusions drawn from the testing results.

    • The benefits of performing ISO 10993-30 testing include:

  • Improved product safety

  • Reduced liability

  • Enhanced compliance with regulatory requirements

  • Increased customer confidence and trust

    • Eurolab offers a comprehensive range of services for ISO 10993-30 testing, including:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

    • ADDITIONAL REQUIREMENTS

    The following additional requirements should be included in the article:

  • Use professional and technical language appropriate for laboratory testing.

  • Include relevant technical specifications and parameters.

  • Provide industry-specific examples of compliance with ISO 10993-30.

  • Emphasize the importance of regular updates to standards.

    • By following this guide, readers will gain a comprehensive understanding of ISO 10993-30 testing requirements and benefits, as well as why Eurolab is an ideal choice for providing these services.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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