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iso-10993-18-chemical-characterization-of-medical-device-materials
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 176.170 Substances in Contact with Aqueous Foods – Extractables21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 3.2.9 Rubber Closures – Extractables AnalysisEP 5.1.1 Biological Safety – Leachables Toxicity AssessmentFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 11607-1 Package Integrity for Sterile Medical DevicesISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031.1> Analytical Instrument Qualification for Extractables StudiesUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1079> Good Storage and Distribution Practices – Leachable RiskUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

ISO 10993-18 Chemical Characterization of Medical Device Materials Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

ISO 10993-18 is a standard developed by the International Organization for Standardization (ISO) that outlines the requirements for chemical characterization of medical device materials. This standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices.

The ISO 10993 series is widely recognized and adopted by regulatory authorities worldwide, including the United States Food and Drug Administration (FDA), the European Unions Notified Bodies, and other national authorities. The standards are designed to ensure that medical devices meet safety and performance requirements, reducing the risk of adverse reactions and ensuring compliance with regulations.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-18 testing is governed by various international and national standards. These include:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

  • ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements

  • ISO 10993-18:2017 Biological evaluation of medical devices Part 18: Chemical characterization of materials

  • ASTM F748-17 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

  • EN ISO 10993-1:2014 Biological evaluation of medical devices Part 1: Evaluation and testing

    • Regulatory authorities, such as the FDA, require manufacturers to demonstrate compliance with these standards through documentation and testing.

    International and National Standards

    The following are some key international and national standards that apply to ISO 10993-18 testing:

  • European Unions Medical Device Regulation (MDR) Article 19: Safety and Performance Requirements

  • US FDA Guidance for Industry Biological Evaluation of Medical Devices

  • Japanese Ministry of Health, Labour and Welfare (MHLW) Ordinance No. 32

    • Standard Development Organizations

    The ISO 10993 series is developed by the Technical Committee ISO/TC 194, which is responsible for developing standards related to biological evaluation of medical devices.

    How Standards Evolve and Get Updated

    Standards are regularly reviewed and updated to reflect advances in technology, changes in regulatory requirements, or emerging risks. This ensures that testing methods remain relevant and effective in ensuring the safety and performance of medical devices.

    Specific Standard Numbers and Their Scope

    The following are some key standard numbers related to ISO 10993-18:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

  • ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements

  • ISO 10993-18:2017 Biological evaluation of medical devices Part 18: Chemical characterization of materials

    • Standard Compliance Requirements for Different Industries

    Manufacturers must comply with these standards to ensure the safety and performance of their medical devices. Failure to comply can result in regulatory non-compliance, product recalls, or even lawsuits.

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    Standard Requirements and Needs

    The ISO 10993-18 test is necessary because it ensures that medical device materials are safe for use on humans and do not pose a risk of adverse reactions.

    Business and Technical Reasons for Conducting ISO 10993-18 Testing

    Conducting the ISO 10993-18 test provides several benefits, including:

  • Ensuring compliance with regulatory requirements

  • Reducing the risk of product recalls

  • Improving customer confidence in product safety

  • Enhancing competitiveness through quality assurance

  • Supporting innovation and research development

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    Test Conditions and Methodology

    The following is a step-by-step explanation of how the ISO 10993-18 test is conducted:

    1. Sample Preparation: Samples are prepared according to standard procedures.

    2. Testing Equipment and Instruments: Specific testing equipment, such as chromatography systems, is used to analyze samples.

    3. Testing Environment Requirements: The testing environment must meet specific requirements, including temperature and humidity control.

    4. Measurement and Analysis Methods: Measurement and analysis methods, such as spectroscopy or chromatography, are used to detect chemical substances.

    5. Calibration and Validation Procedures: Calibration and validation procedures ensure that testing equipment is accurate and reliable.

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    Test Reporting and Documentation

    The following explains how test results are documented and reported:

  • Report Format and Structure: Reports follow a standard format, which includes an introduction, test methods, results, discussion, and conclusions.

  • Interpretation of Test Results: Results are interpreted according to established guidelines.

  • Certification and Accreditation Aspects: Certification and accreditation aspects ensure that testing is carried out by qualified personnel using calibrated equipment.

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    Why This Test Should Be Performed

    The ISO 10993-18 test provides several benefits, including:

  • Risk assessment and mitigation through testing

  • Quality assurance and improvement

  • Enhanced competitiveness through quality assurance

  • Support for innovation and research development

    • ---

    Conclusion

    In conclusion, the ISO 10993-18 chemical characterization of medical device materials laboratory testing service is a critical component of ensuring the safety and performance of medical devices. By understanding standard-related information, legal and regulatory frameworks, and test conditions and methodology, manufacturers can ensure compliance with regulatory requirements and reduce the risk of adverse reactions.

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    Persuasive Argument

    By conducting the ISO 10993-18 test, manufacturers can:

  • Ensure compliance with regulatory requirements

  • Reduce the risk of product recalls

  • Improve customer confidence in product safety

  • Enhance competitiveness through quality assurance

    • The benefits of conducting this test far outweigh the costs and risks associated with non-compliance.

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