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iso-10993-13-degradation-products-analysis-for-polymeric-medical-devices
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 10993-14 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

ISO 10993-13 Degradation Products Analysis for Polymeric Medical Devices Laboratory Testing Service: A Comprehensive Guide

ISO 10993-13 is a standard that outlines the requirements for degradation products analysis for polymeric medical devices. The standard is part of the ISO 10993 series, which deals with the biological evaluation of medical devices.

1.1 Overview of Relevant Standards

The following standards are relevant to ISO 10993-13:

  • ISO 10993: Biological Evaluation of Medical Devices

    • Part 1: Evaluation and Testing in vitro

    Part 2: Animal Welfare Requirements

    Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity

    ...

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

  • EN ISO 10993-13: Biological Evaluation of Medical Devices Part 13: Degradation Products in Polymeric Medical Devices

  • TSE ISO 10993-13: Turkish Standards Institution equivalent to EN ISO 10993-13

    • 1.2 Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 10993-13 is governed by international and national standards.

  • International Standards: ISO 10993, ASTM F748

  • National Standards: EU Medical Device Regulation (MDR), US FDA CFR Part 21, Chinese National Standard GB/T 16886.2

    • 1.3 Standard Development Organizations

    The following organizations play a crucial role in the development and maintenance of standards related to ISO 10993-13:

  • ISO: International Organization for Standardization

  • ASTM: American Society for Testing and Materials

  • CEN: European Committee for Standardization (EN)

    • 1.4 Standard Evolution and Updates

    Standards evolve over time, reflecting advancements in technology, science, and regulatory requirements.

  • Revision History: ISO 10993-13:2017(E) replaced ISO 10993-13:1998

  • Future Developments: Ongoing work on revising the standard to include emerging technologies and methodologies

    • 1.5 Standard Compliance Requirements

    Compliance with ISO 10993-13 is mandatory for medical device manufacturers, importers, and distributors.

  • EU MDR: Annex I, Section 22

  • US FDA CFR Part 21: Subpart C

  • Chinese National Standard GB/T 16886.2

    • 2.1 Why this Test is Needed

    ISO 10993-13 Degradation Products Analysis for Polymeric Medical Devices testing is essential to ensure the safety and efficacy of medical devices.

  • Risk Assessment: Identifies potential hazards associated with degradation products

  • Quality Assurance: Demonstrates compliance with regulatory requirements

  • Product Safety: Ensures device performance, durability, and reliability

    • 2.2 Business and Technical Reasons for Testing

    Conducting ISO 10993-13 Degradation Products Analysis for Polymeric Medical Devices testing provides numerous benefits.

  • Regulatory Compliance: Avoids costly fines, recalls, or market withdrawal

  • Product Development: Enhances device performance, safety, and efficacy

  • Competitive Advantage: Demonstrates commitment to quality and customer satisfaction

    • 2.3 Consequences of Not Performing this Test

    Failure to conduct ISO 10993-13 Degradation Products Analysis for Polymeric Medical Devices testing can have severe consequences.

  • Regulatory Non-Compliance: Fines, recalls, or market withdrawal

  • Reputation Damage: Loss of customer trust and loyalty

  • Market Access Restrictions: Difficulty entering new markets or maintaining existing ones

    • 3.1 Overview of Testing Procedure

    The ISO 10993-13 Degradation Products Analysis for Polymeric Medical Devices testing process involves several stages.

  • Sample Preparation: Ensures representative sample selection

  • Testing Parameters: Sets conditions for degradation product analysis (temperature, humidity, pressure)

  • Measurement and Analysis: Identifies and quantifies degradation products

    • 3.2 Testing Equipment and Instruments

    The following equipment and instruments are used to conduct the test.

  • Spectroscopy: Fourier Transform Infrared Spectrometry (FTIR), Gas Chromatography-Mass Spectrometry (GC-MS)

  • Chromatography: High-Performance Liquid Chromatography (HPLC), Size Exclusion Chromatography (SEC)

    • 3.3 Testing Environment Requirements

    The testing environment must meet specific conditions.

  • Temperature: Controlled temperature range (e.g., 25C 2C)

  • Humidity: Maintains a stable relative humidity (50 10)

    • ...

    This is just the beginning of the comprehensive guide to ISO 10993-13 Degradation Products Analysis for Polymeric Medical Devices laboratory testing services. The full document will cover all aspects of the standard, including:

  • Standard-Related Information

  • Standard Requirements and Needs

  • Test Conditions and Methodology

  • Reporting and Documentation

  • Quality Assurance and Control

  • Future Developments and Updates

    • Please let me know if youd like me to continue with the rest of the guide.

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