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iso-10993-15-identification-of-degradation-products-from-metals
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 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 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 10993-15 Identification of Degradation Products from Metals Laboratory Testing Service: A Comprehensive Guide

The ISO 10993-15 standard is part of the International Organization for Standardizations (ISO) family of standards related to biocompatibility and safety assessment of medical devices. Specifically, this standard focuses on the identification of degradation products from metals used in medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-15 testing is governed by various international and national standards. The most relevant ones include:

  • ISO 10993-1:2018, which provides a framework for biocompatibility assessment

  • ISO 10993-17:2019, which covers the evaluation of medical devices that use metallic materials

  • ASTM F748-02 (2013), which outlines a procedure for evaluating the safety and efficacy of implantable medical devices

  • EN ISO 14638, which provides requirements for the biocompatibility testing of metallic biomaterials

    • Standard Development Organizations

    Standard development organizations play a crucial role in creating and maintaining standards related to biocompatibility assessment. Some notable examples include:

    1. International Organization for Standardization (ISO)

    2. American Society for Testing and Materials (ASTM)

    3. European Committee for Standardization (CEN)

    How Standards Evolve and Get Updated

    Standards undergo continuous review and updating to reflect the latest scientific knowledge, technological advancements, and regulatory requirements. This process involves:

    1. Research and development of new standards or revisions

    2. Stakeholder engagement and feedback

    3. Balloting and consensus-building among member organizations

    Standard Numbers and Scope

    Some relevant standard numbers related to ISO 10993-15 testing include:

  • ISO 10993-1:2018, Medical devices - Part 1: Evaluation of biocompatibility

  • ISO 10993-17:2019, Medical devices - Part 17: Evaluation of medical devices that use metallic materials

    • Industry-Specific Compliance Requirements

    Different industries have specific compliance requirements for biocompatibility testing. For example:

    1. Medical device manufacturers must comply with ISO 10993-15

    2. Pharmaceutical companies may require ISO 10993-15 testing for certain products

    3. Regulatory agencies, such as the US FDA and European Commission, enforce standards related to biocompatibility assessment

    Why This Test is Needed

    ISO 10993-15 testing is necessary to ensure the safety and efficacy of medical devices that use metallic materials. The consequences of not performing this test can be severe:

  • Inadequate testing may lead to device failure or adverse reactions

  • Failure to comply with regulatory requirements can result in product recalls, fines, or even lawsuits

    • Business and Technical Reasons for Conducting ISO 10993-15 Testing

    Conducting ISO 10993-15 testing provides numerous business and technical benefits:

    1. Product Safety: Ensures the safety of medical devices and minimizes risks to patients

    2. Compliance: Helps companies comply with regulatory requirements and industry standards

    3. Quality Assurance: Provides a framework for quality assurance and quality control in biocompatibility assessment

    Risk Factors and Safety Implications

    The risk factors associated with metal degradation products include:

    1. Toxicity: Release of toxic substances that can cause adverse reactions or harm patients

    2. Corrosion: Potential for corrosion-related problems, such as device failure or material degradation

    3. Biocompatibility: Risk of adverse reactions or interactions between the device and the body

    Quality Assurance and Quality Control Aspects

    ISO 10993-15 testing involves a range of quality assurance and quality control measures:

    1. Sample Preparation: Ensures that samples are properly prepared for testing

    2. Testing Parameters: Verifies that testing parameters are consistent with standard requirements

    3. Measurement and Analysis: Accurately measures and analyzes degradation products

    Competitive Advantages of Performing ISO 10993-15 Testing

    Performing ISO 10993-15 testing can provide several competitive advantages:

    1. Enhanced Product Safety: Demonstrates a commitment to product safety and patient well-being

    2. Regulatory Compliance: Helps companies comply with regulatory requirements and industry standards

    3. Improved Quality Assurance: Provides a framework for quality assurance and quality control in biocompatibility assessment

    Cost-Benefit Analysis of Performing ISO 10993-15 Testing

    Conducting ISO 10993-15 testing can have several cost benefits:

    1. Reduced Regulatory Risks: Minimizes the risk of regulatory non-compliance

    2. Improved Product Quality: Enhances product quality and safety

    3. Increased Customer Confidence: Demonstrates a commitment to product safety and patient well-being

    Test Procedure

    The test procedure for ISO 10993-15 involves:

    1. Sample Preparation: Ensures that samples are properly prepared for testing

    2. Testing Parameters: Verifies that testing parameters are consistent with standard requirements

    3. Measurement and Analysis: Accurately measures and analyzes degradation products

    Equipment Used

    Some equipment used in ISO 10993-15 testing includes:

    1. Spectrometers: Measures the presence of metal ions or other degradation products

    2. Chromatography Systems: Separates and detects specific substances in samples

    3. Microscopes: Examines sample morphology and microstructure

    Data Analysis

    Data analysis for ISO 10993-15 testing involves:

    1. Statistical Analysis: Evaluates the statistical significance of results

    2. Sensitivity and Specificity: Calculates sensitivity and specificity to assess test performance

    3. Limit of Detection: Determines the limit of detection for specific substances

    Reporting Requirements

    ISO 10993-15 testing requires reporting of:

    1. Test Results: Provides detailed information on test results, including any degradation products detected

    2. Method Validation: Verifies the accuracy and reliability of testing methods used

    3. Quality Control Measures: Describes quality control measures implemented during testing

    Conclusion

    ISO 10993-15 testing is a critical component of biocompatibility assessment for medical devices that use metallic materials. This standard ensures the safety and efficacy of products, while also providing numerous business and technical benefits.

    By following the guidelines outlined in this document, companies can ensure compliance with regulatory requirements, improve product quality, and enhance customer confidence.

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