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astm-f2459-extractable-residue-from-metallic-medical-components
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 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 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

Comprehensive Guide to ASTM F2459 Extractable Residue from Metallic Medical Components Testing Services Provided by Eurolab

ASTM F2459 is a standard test method for determining the extractable residue from metallic medical components. This standard is part of the American Society for Testing and Materials (ASTM) International portfolio, which provides technical standards for a wide range of materials, products, and services.

International and National Standards

The international standards governing ASTM F2459 testing are:

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

  • ASTM F2383/F2383M-19 - Standard Guide for Selection of Sample Preparation Methods for Determining the Extractable Residue from Metallic Medical Components

    • National standards may also apply, depending on the countrys regulatory requirements. In Europe, for example, EN ISO 10993-18:2017 is a harmonized standard that replaces the separate national standards.

    Standard Development Organizations

    ASTM International and ISO/TC 194/WG 10 are responsible for developing and maintaining the relevant standards governing ASTM F2459 testing. These organizations ensure that the standards remain up-to-date and reflect the latest scientific knowledge and regulatory requirements.

    Evolution of Standards

    Standards evolve as new research emerges, and regulatory requirements change. The development process involves consultation with industry experts, regulatory bodies, and other stakeholders to ensure that the updated standards meet the needs of all parties involved.

    Standard Numbers and Scope

    The relevant standard numbers and their scope are:

  • ASTM F2459 - Standard Test Method for Determining Extractable Residue from Metallic Medical Components

    • Applies to metallic medical components intended for use in contact with living tissues.

    Provides a method for determining the extractable residue from these components.

    Standard Compliance Requirements

    Industry-specific standard compliance requirements are as follows:

  • Medical Device Manufacturers: Must comply with ASTM F2459 and ISO 10993-18 standards to demonstrate the safety of their products.

  • Regulatory Bodies: Ensure that medical device manufacturers meet the applicable standards, including ASTM F2459.

    • Why This Standard is Required

    The extractable residue from metallic medical components can pose a risk to patients health. ASTM F2459 testing provides a critical tool for ensuring the safety and efficacy of these devices.

    Consequences of Not Performing This Test

    Failure to perform ASTM F2459 testing may result in:

  • Inadequate product safety

  • Regulatory non-compliance

  • Damage to reputation and brand image

    • Industries and Sectors that Require this Testing

    Medical device manufacturers, including those producing implants, surgical instruments, and diagnostic equipment, require ASTM F2459 testing.

    Risk Factors and Safety Implications

    The extractable residue from metallic medical components can cause:

  • Toxicity

  • Irritation

  • Infection

    • ASTM F2459 testing helps mitigate these risks by ensuring that the extractable residue is within acceptable limits.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality management system ensures that ASTM F2459 testing is performed with the highest level of accuracy, precision, and reliability.

    Competitive Advantages and Market Positioning

    Performing ASTM F2459 testing demonstrates a commitment to product safety, regulatory compliance, and customer confidence. This can lead to:

  • Increased market share

  • Improved brand reputation

  • Enhanced customer loyalty

    • Cost-Benefit Analysis

    The cost of performing ASTM F2459 testing is minimal compared to the potential costs associated with non-compliance or product failure.

    ---

    Why This Specific Test is Needed and Required

    ASTM F2459 testing provides a critical tool for ensuring the safety and efficacy of metallic medical components. The extractable residue from these devices can pose a risk to patients health, making this test essential.

    Business and Technical Reasons for Conducting ASTM F2459 Testing

  • Ensure product safety and regulatory compliance

  • Mitigate risks associated with extractable residue

  • Enhance customer confidence and brand reputation

    • Consequences of Not Performing This Test

    Failure to perform ASTM F2459 testing may result in:

  • Inadequate product safety

  • Regulatory non-compliance

  • Damage to reputation and brand image

    • Industries and Sectors that Require this Testing

    Medical device manufacturers, including those producing implants, surgical instruments, and diagnostic equipment, require ASTM F2459 testing.

    Risk Factors and Safety Implications

    The extractable residue from metallic medical components can cause:

  • Toxicity

  • Irritation

  • Infection

    • ASTM F2459 testing helps mitigate these risks by ensuring that the extractable residue is within acceptable limits.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality management system ensures that ASTM F2459 testing is performed with the highest level of accuracy, precision, and reliability.

    ---

    Test Conditions

    ASTM F2459 testing involves subjecting metallic medical components to various conditions, including:

  • Extraction with solvents

  • Measurement of extractable residue using techniques such as chromatography or spectroscopy

    • Methodology

    The test methodology for ASTM F2459 is outlined in the standard and involves the following steps:

    1. Sample preparation

    2. Extraction

    3. Measurement of extractable residue

    4. Calculation of results

    ---

    Test Equipment

    ASTM F2459 testing requires specialized equipment, including:

  • Extraction apparatuses

  • Chromatography or spectroscopy instruments

  • Solvent systems

    • Materials

    The following materials are required for ASTM F2459 testing:

  • Metallic medical components to be tested

  • Solvents and reagents

  • Standards and reference materials

    • ---

    Step 1: Sample Preparation

    Metallic medical components must be prepared according to the standards requirements.

    Step 2: Extraction

    The sample is subjected to extraction using a solvent or combination of solvents.

    Step 3: Measurement of Extractable Residue

    The extractant is analyzed for extractable residue using chromatography or spectroscopy techniques.

    Step 4: Calculation of Results

    Results are calculated and reported according to the standards requirements.

    ---

    Validation

    ASTM F2459 testing requires validation of the test procedure, including:

  • Interlaboratory studies

  • Method validation using reference materials

    • Calibration

    Equipment must be calibrated regularly to ensure accuracy and precision.

    ---

    Data Analysis

    Results are analyzed according to the standards requirements, including statistical analysis.

    Reporting

    Results are reported in a clear and concise manner, including:

  • Extractable residue levels

  • Comparison with acceptable limits

  • Conclusion regarding product safety and regulatory compliance

    • ---

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