EUROLAB
iso-10993-17-toxicological-risk-assessment-for-leachables
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 10993-18 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 ISO 10993-17 Toxicological Risk Assessment for Leachables Laboratory Testing Service Provided by Eurolab

ISO 10993-17 is a standard that governs the toxicological risk assessment of leachables from medical devices. This standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices. The standard is developed by the International Organization for Standardization (ISO) in collaboration with other standard development organizations.

Legal and Regulatory Framework

The regulatory framework surrounding ISO 10993-17 is primarily driven by the European Unions Medical Device Regulation (MDR). According to Article 10 of the MDR, medical devices must undergo a thorough risk assessment to ensure they meet safety and performance requirements. The standard is also referenced in the US Food and Drug Administrations (FDA) guidelines for medical device testing.

International and National Standards

The following standards are relevant to ISO 10993-17:

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

  • ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

  • ASTM F748-14 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

  • EN ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and risk management

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is the primary standard development organization responsible for developing and maintaining the ISO 10993 series. Other organizations, such as ASTM and CEN (Comité Européen de Normalisation), also contribute to the development of standards related to biological evaluation.

    Standard Evolution and Updates

    Standards undergo regular updates to reflect new scientific knowledge and regulatory requirements. The ISO 10993-17 standard has undergone several revisions since its initial publication in 2006, with the latest version being published in 2018.

    Compliance Requirements

    Medical device manufacturers must comply with relevant standards to ensure their devices meet safety and performance requirements. Compliance with ISO 10993-17 is essential for medical device manufacturers seeking to market their products in Europe and other regions where the standard is recognized.

    Industry-Specific Examples and Case Studies

    The pharmaceutical industry, in particular, requires compliance with ISO 10993-17 due to the potential risks associated with leachables from packaging materials. A case study on a generic drug product showed that testing for leachables according to ISO 10993-17 helped identify potential contaminants and ensured product safety.

    Why This Test is Needed

    The toxicological risk assessment of leachables from medical devices is essential to ensure product safety. Leachables can pose a risk to patients, particularly those with sensitivities or allergies. Testing for leachables helps identify potential contaminants and ensures compliance with regulatory requirements.

    Business and Technical Reasons

    Conducting ISO 10993-17 testing provides several business benefits, including:

  • Ensuring product safety and reducing liability

  • Complying with regulatory requirements

  • Enhancing brand reputation and customer trust

    • From a technical perspective, testing for leachables helps identify potential contaminants that can compromise device performance or cause adverse reactions.

    Consequences of Not Performing This Test

    Not conducting ISO 10993-17 testing can result in:

  • Regulatory non-compliance and fines

  • Product recalls and reputational damage

  • Adverse patient reactions and liability

    • Industries and Sectors Requiring This Testing

    Medical device manufacturers, pharmaceutical companies, and packaging material suppliers require compliance with ISO 10993-17.

    Risk Factors and Safety Implications

    Leachables from medical devices can pose a risk to patients, particularly those with sensitivities or allergies. The toxicological risk assessment of leachables helps identify potential contaminants and ensures product safety.

    Quality Assurance and Control Aspects

    Eurolab adheres to strict quality assurance and control procedures to ensure accurate and reliable testing results.

    Competitive Advantages and Cost-Benefit Analysis

    Conducting ISO 10993-17 testing provides several competitive advantages, including:

  • Enhanced brand reputation and customer trust

  • Compliance with regulatory requirements

  • Reduced liability and product recalls

    • The cost-benefit analysis of performing this test is favorable, as it helps prevent costly product recalls and reputational damage.

    Step-by-Step Explanation

    Eurolabs laboratory testing service for ISO 10993-17 follows a comprehensive step-by-step approach:

    1. Sample preparation

    2. Testing for leachables

    3. Data analysis and interpretation

    Testing Equipment and Instruments

    Eurolab uses state-of-the-art equipment and instruments, including high-performance liquid chromatography (HPLC) systems and mass spectrometry (MS).

    Data Analysis and Interpretation

    Results are analyzed using specialized software to ensure accurate and reliable testing results.

    Test Conditions and Methodology Variations

    Variations in test conditions and methodology may be required depending on the specific medical device or packaging material being tested.

    Quality Control Procedures

    Eurolab adheres to strict quality control procedures, including:

  • Regular instrument calibration

  • Maintenance of laboratory standards

  • Training for laboratory personnel

    • Test Report and Certification

    A comprehensive test report is issued after completion of the testing process. The report includes results, analysis, and recommendations for future improvements.

    Conclusion

    In conclusion, ISO 10993-17 is a critical standard that governs the toxicological risk assessment of leachables from medical devices. Eurolabs laboratory testing service provides a comprehensive approach to ensure compliance with regulatory requirements and product safety.

    The following sections will provide further information on EUROLABs laboratory testing services for ISO 10993-17, including:

  • Test procedures

  • Equipment and instruments used

  • Quality control procedures

  • Test report and certification

    • Test Procedures

    Eurolabs laboratory testing service follows a comprehensive step-by-step approach to ensure accurate and reliable testing results.

    1. Sample preparation: Samples are prepared according to ISO 10993-17 guidelines.

    2. Testing for leachables: Leachables are tested using HPLC systems and MS.

    3. Data analysis and interpretation: Results are analyzed using specialized software to ensure accurate and reliable testing results.

    Equipment and Instruments Used

    Eurolab uses state-of-the-art equipment and instruments, including:

  • High-performance liquid chromatography (HPLC) systems

  • Mass spectrometry (MS)

  • Gas chromatography-mass spectrometry (GC-MS)

    • Quality Control Procedures

    Eurolab adheres to strict quality control procedures, including:

  • Regular instrument calibration

  • Maintenance of laboratory standards

  • Training for laboratory personnel

    • Test Report and Certification

    A comprehensive test report is issued after completion of the testing process. The report includes results, analysis, and recommendations for future improvements.

    Certification

    Eurolab is certified to ISO 17025:2017 by a recognized accreditation body.

    Please note that this document provides an overview of EUROLABs laboratory testing services for ISO 10993-17. For more information or to request a quote, please contact us at insert contact details.

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