EUROLAB
iso-10993-16-toxicokinetics-of-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 10993-17 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 10993-30 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 10993-16 Toxicokinetics of Materials Laboratory Testing Service Provided by Eurolab

ISO 10993-16 is a standard that outlines the toxicokinetic study requirements for medical devices, including in vitro and in vivo studies. The standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices.

1.1 Overview of Relevant Standards

The relevant standards governing ISO 10993-16 testing are:

  • ISO 10993-1:2009 (Medical devices Part 1: Evaluation and testing within a risk management process)

  • ISO 10993-2:1994 (Medical devices Part 2: Toxicological evaluation)

  • ISO 10993-3:2009 (Medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity)

  • ISO 10993-5:2013 (Medical devices Part 5: Tests for in vitro cytotoxicity)

  • ISO 10993-16:2010 (Medical devices Part 16: Toxicokinetics)

    • 1.2 Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 10993-16 testing is governed by various international and national standards, including:

  • EU Medical Device Regulation (EU) 2017/745

  • FDAs Good Laboratory Practice Regulations (21 CFR Part 58)

  • ISO 13485:2016 (Medical devices Quality management systems Requirements for regulatory purposes)

    • 1.3 Standard Development Organizations

    The standard development organizations involved in the creation and maintenance of ISO 10993-16 are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • 1.4 Evolution and Updates

    Standards evolve through a collaborative process between experts from various industries, regulatory bodies, and standard development organizations. Updates to the standards are published periodically to reflect changes in technology, science, and regulations.

    ISO 10993-16 testing is required for medical devices that come into contact with tissues or organs of the human body. The test evaluates the toxicokinetics of a devices chemical constituents, including their absorption, distribution, metabolism, and excretion.

    2.1 Business and Technical Reasons

    The business and technical reasons for conducting ISO 10993-16 testing include:

  • Ensuring product safety and reliability

  • Compliance with regulatory requirements

  • Protecting human health and the environment

  • Minimizing liability risks

    • 2.2 Consequences of Not Performing the Test

    Not performing the test can result in:

  • Regulatory non-compliance

  • Product recalls or bans

  • Financial losses due to liabilities and lawsuits

  • Damage to reputation and brand image

    • 2.3 Industries and Sectors Requiring Testing

    The following industries and sectors require ISO 10993-16 testing:

  • Medical devices (implantable, surgical, and diagnostic)

  • Pharmaceutical products

  • Cosmetics and personal care products

  • Food packaging materials

    • 2.4 Risk Factors and Safety Implications

    Risk factors associated with medical device materials include:

  • Chemical toxicity

  • Physical toxicity

  • Biocompatibility

  • Infection risk

    • Safety implications of non-compliance include:

  • Patient harm or death

  • Device failure or malfunction

  • Economic losses due to product recalls or bans

    • 2.5 Quality Assurance and Quality Control

    Quality assurance and quality control aspects of ISO 10993-16 testing include:

  • Standard operating procedures (SOPs)

  • Calibration and validation protocols

  • Data collection and recording procedures

  • Statistical analysis and interpretation of results

    • The test conditions and methodology for ISO 10993-16 testing involve:

  • Sample preparation and selection

  • In vitro testing using cell cultures or tissue explants

  • In vivo testing using animal models

  • Toxicokinetic analysis using mathematical modeling

    • 3.1 Testing Equipment and Instruments

    Equipment and instruments used in the test include:

  • Autoclaves for sterilization

  • Incubators for temperature control

  • Microscopes for observation

  • Spectrophotometers for chemical analysis

    • 3.2 Testing Environment Requirements

    Testing environment requirements include:

  • Temperature: 20-25C (68-77F)

  • Humidity: 50-60 relative humidity

  • Pressure: Atmospheric pressure

  • Lighting: Normal indoor lighting conditions

    • The test reporting and documentation process involves:

  • Compiling raw data from testing equipment

  • Data analysis using statistical software

  • Interpretation of results in the context of product safety

  • Preparing a final report according to standard formats

    • 4.1 Report Formats

    Report formats include:

  • Standardized templates (e.g., ISO 10993-16:2010)

  • Customized reports for specific client requirements

  • Electronic submission via secure online platforms

    • 5. Benefits of Choosing Eurolab for ISO 10993-16 Testing

    Eurolab offers a range of benefits for clients requiring ISO 10993-16 testing, including:

  • Expertise in biological evaluation and toxicokinetic studies

  • State-of-the-art facilities and equipment

  • Compliance with regulatory requirements

  • Timely and accurate reporting

    • Conclusion

    ISO 10993-16 testing is an essential requirement for medical devices that come into contact with human tissues or organs. Eurolab provides comprehensive support for clients requiring this type of testing, including expertise in toxicokinetic studies, state-of-the-art facilities, and compliance with regulatory requirements.

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    Please note that the above content is a draft and may require further modifications to meet specific needs. Additionally, the text should be reviewed by subject matter experts to ensure accuracy and relevance to the current standards and regulations.

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