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astm-f1980-accelerated-aging-for-stability-of-extractables
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 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 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 F1980 Accelerated Aging for Stability of Extractables Testing Services

Standard-Related Information

ASTM F1980 Accelerated Aging for Stability of Extractables is a laboratory testing service that evaluates the stability of extractables from medical devices, equipment, and materials. The standard is governed by the American Society for Testing and Materials (ASTM) International.

Legal and Regulatory Framework

The ASTM F1980 standard is influenced by various laws and regulations, including:

  • FDA Regulation 21 CFR 880: Establishes requirements for medical devices, including those related to extractables.

  • ISO 10993-1:2009: Provides guidance on biocompatibility testing of medical devices.

  • EN ISO 10993-12:2012: Specifies requirements for packaging and labeling of medical devices.

    • International and National Standards

    The following standards apply to ASTM F1980 Accelerated Aging for Stability of Extractables:

  • ASTM F1980-16: Standard practice for accelerated aging of extractables from materials used in medical devices.

  • ISO 10993-1:2009: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.

  • EN ISO 10993-12:2012: Biological evaluation of medical devices Part 12: Sample preparation and reference materials.

    • Standard Development Organizations

    ASTM International is the standard development organization responsible for ASTM F1980. Other organizations, such as ISO and EN, also contribute to the development of related standards.

    Evolution of Standards

    Standards are continually updated to reflect changes in technology, regulatory requirements, and industry practices. Eurolab stays up-to-date with the latest developments in this field.

    Standard Compliance Requirements

    Medical device manufacturers must comply with ASTM F1980 when testing extractables from their products. Failure to comply can result in product recalls or other regulatory actions.

    Standard Requirements and Needs

    Why This Test is Needed and Required

    ASTM F1980 Accelerated Aging for Stability of Extractables testing is necessary to ensure the safety and efficacy of medical devices. The test helps identify potential extractables that may leach from materials used in these devices.

    Business and Technical Reasons for Conducting ASTM F1980 Testing

    Conducting ASTM F1980 testing provides several benefits, including:

  • Compliance with regulatory requirements: Ensures compliance with FDA Regulation 21 CFR 880 and other relevant standards.

  • Product safety and efficacy: Identifies potential extractables that may impact product performance or user safety.

  • Quality assurance and control: Demonstrates a commitment to quality and customer satisfaction.

    • Consequences of Not Performing This Test

    Failure to conduct ASTM F1980 testing can result in:

  • Regulatory actions: Product recalls, fines, or other penalties for non-compliance with regulatory requirements.

  • Product failure: Extractables may leach from materials used in medical devices, impacting product performance or user safety.

  • Loss of customer trust: Failure to ensure product safety and efficacy can damage a companys reputation and relationships with customers.

    • Industries and Sectors that Require This Testing

    Medical device manufacturers, equipment suppliers, and other related industries require ASTM F1980 testing.

    Risk Factors and Safety Implications

    Extractables from medical devices may pose health risks to users. ASTM F1980 testing helps identify potential extractables and ensures product safety.

    Quality Assurance and Control Aspects

    ASTM F1980 testing demonstrates a commitment to quality assurance and control, ensuring products meet regulatory requirements and customer expectations.

    Competitive Advantages of Having This Testing Performed

    Companies that conduct ASTM F1980 testing demonstrate their commitment to product safety and efficacy, which can lead to:

  • Increased customer trust: Customers are more likely to purchase from companies that prioritize product safety and quality.

  • Improved market positioning: Companies that conduct ASTM F1980 testing can differentiate themselves from competitors and establish a reputation for excellence.

  • Reduced regulatory risks: Compliance with regulatory requirements reduces the risk of regulatory actions, fines, or other penalties.

    • Cost-Benefit Analysis

    The benefits of conducting ASTM F1980 testing far outweigh the costs. Companies that invest in this testing can:

  • Avoid costly product recalls: Identify potential extractables and address issues before products reach the market.

  • Reduce regulatory risks: Ensure compliance with regulatory requirements and avoid fines or other penalties.

  • Improve customer trust and loyalty: Demonstrate a commitment to product safety and quality, leading to increased customer satisfaction and retention.

    • Test Conditions and Methodology

    Step-by-Step Explanation of How the Test is Conducted

    ASTM F1980 testing involves several steps:

    1. Sample preparation: Prepare test samples according to ASTM F1980 requirements.

    2. Testing equipment and instruments: Use specialized equipment and instruments, such as accelerated aging chambers and gas analyzers.

    3. Testing conditions: Apply controlled temperatures and humidity levels to simulate real-world use conditions.

    4. Data analysis: Analyze results using statistical methods and software tools.

    Testing Equipment and Instruments

    ASTM F1980 testing requires specialized equipment and instruments, including:

  • Accelerated aging chambers: Simulate long-term exposure to heat, moisture, or other environmental factors.

  • Gas analyzers: Measure the concentration of extractables in test samples.

  • Spectroscopic analysis: Identify chemical compounds present in test samples.

    • Testing Conditions

    ASTM F1980 testing involves controlled temperatures and humidity levels:

  • Temperature range: 25C to 40C (77F to 104F)

  • Humidity range: 20 to 80

    • Data Analysis

    Results are analyzed using statistical methods and software tools, including:

  • Regression analysis: Identify relationships between variables.

  • Principal component analysis: Reduce dimensionality of large datasets.

    • Conclusion

    ASTM F1980 Accelerated Aging for Stability of Extractables testing is essential for ensuring product safety and efficacy in the medical device industry. By following this comprehensive guide, companies can ensure compliance with regulatory requirements, reduce risks, and improve customer trust and loyalty.

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