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iso-18562-4-leachable-particulates-in-medical-gas-pathway-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 10993-13 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/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 18562-4 Leachable Particulates in Medical Gas Pathway Devices Laboratory Testing Service Provided by Eurolab

ISO 18562-4 is a standard that governs the testing of leachable particulates in medical gas pathway devices. This standard is part of the ISO 18562 series, which covers the testing of medical devices for potential leachables and extractables from materials used in their construction.

International Standards

  • ISO 18562-1:2018: Medical gases - Leachable particulates - Part 1: General requirements

  • ISO 18562-2:2020: Medical gases - Leachable particulates - Part 2: Sampling and sample preparation

  • ISO 18562-3:2020: Medical gases - Leachable particulates - Part 3: Methods for the determination of leachable particulates in medical gas pathway devices

  • ISO 18562-4:2017: Medical gases - Leachable particulates - Part 4: Testing and documentation requirements

    • National Standards

  • ASTM F2388-17: Standard Practice for Determination of Extractables from Medical Devices

  • EN ISO 13485:2016A1:2020: Medical devices - Quality management systems - Requirements for regulatory purposes

  • TSE IEC/TS 60601-2-41:2020: Medical electrical equipment - Part 2-41: Particular requirements for the safety and essential performance of medical gas containers and related equipment

    • Standard Development Organizations

    The ISO 18562 series is developed by the International Organization for Standardization (ISO) in collaboration with other standard development organizations, including:

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve and get updated to reflect new technologies, research findings, and regulatory requirements. The ISO 18562 series is regularly reviewed and updated to ensure that it remains relevant and effective in ensuring the safety and performance of medical gas pathway devices.

    Standard Compliance Requirements

    Medical device manufacturers must comply with the relevant standards for their products, including ISO 18562-4. Non-compliance can result in regulatory action, product recalls, and damage to reputation.

    Industry-Specific Examples and Case Studies

    The following industries require compliance with ISO 18562-4:

  • Medical gas containers

  • Anaesthetic systems

  • Oxygen concentrators

  • Respiratory therapy equipment

    • Failure to comply with ISO 18562-4 can result in product failures, patient harm, and financial losses.

    Consequences of Non-Compliance

    The consequences of non-compliance with ISO 18562-4 include:

  • Regulatory action (fines, penalties)

  • Product recalls

  • Damage to reputation

  • Financial losses

    • Quality Assurance and Quality Control Aspects

    ISO 18562-4 emphasizes the importance of quality assurance and quality control in medical gas pathway device testing. Manufacturers must ensure that their products meet the relevant standards for safety, performance, and quality.

    Why is ISO 18562-4 Testing Required?

    ISO 18562-4 testing is required to ensure that medical gas pathway devices are safe for use in medical applications. The standard specifies methods for the determination of leachable particulates, which can be harmful to patients.

    Business and Technical Reasons for Conducting ISO 18562-4 Testing

    Conducting ISO 18562-4 testing provides several business and technical benefits:

  • Ensures compliance with regulatory requirements

  • Reduces risk of product failures and recalls

  • Improves product safety and performance

  • Enhances reputation and customer confidence

    • Industries and Sectors that Require ISO 18562-4 Testing

    The following industries require ISO 18562-4 testing:

  • Medical gas containers

  • Anaesthetic systems

  • Oxygen concentrators

  • Respiratory therapy equipment

    • Risk Factors and Safety Implications

    Leachable particulates can be harmful to patients, causing respiratory problems, allergic reactions, and other health issues. Manufacturers must ensure that their products meet the relevant standards for safety and performance.

    Quality Assurance and Quality Control Aspects

    ISO 18562-4 emphasizes the importance of quality assurance and quality control in medical gas pathway device testing. Manufacturers must ensure that their products meet the relevant standards for safety, performance, and quality.

    Competitive Advantages of Having ISO 18562-4 Testing Performed

    Performing ISO 18562-4 testing provides several competitive advantages:

  • Enhances reputation and customer confidence

  • Improves product safety and performance

  • Ensures compliance with regulatory requirements

  • Reduces risk of product failures and recalls

    • Cost-Benefit Analysis

    The cost-benefit analysis for conducting ISO 18562-4 testing is positive, as it reduces the risk of product failures and recalls, improves product safety and performance, and enhances reputation and customer confidence.

    ISO 18562-3 specifies methods for the determination of leachable particulates in medical gas pathway devices. The following test methods are specified:

  • Sample preparation

  • Extraction

  • Separation and detection

  • Quantification

    • ISO 18562-4 emphasizes the importance of documenting test results, including:

  • Sampling and sample preparation procedures

  • Extraction and separation methods

  • Detection and quantification methods

  • Results and conclusions

    • Test Reporting and Certification

    Manufacturers must ensure that their products meet the relevant standards for safety, performance, and quality. Test reports and certification are essential to demonstrate compliance with ISO 18562-4.

    Conclusion

    ISO 18562-4 is a standard that governs the testing of leachable particulates in medical gas pathway devices. Manufacturers must comply with this standard to ensure that their products meet the relevant standards for safety, performance, and quality. Failure to comply can result in regulatory action, product recalls, and damage to reputation.

    Recommendations

    The following recommendations are made:

  • Manufacturers should comply with ISO 18562-4

  • Test reports and certification should be provided to demonstrate compliance with ISO 18562-4

  • Continuous monitoring and testing should be performed to ensure that products meet the relevant standards for safety, performance, and quality.

    • ISO 18562-3 specifies methods for the determination of leachable particulates in medical gas pathway devices. The following test methods are specified:

  • Sample preparation

  • Extraction

  • Separation and detection

  • Quantification

    • ISO 18562-4 emphasizes the importance of documenting test results, including:

  • Sampling and sample preparation procedures

  • Extraction and separation methods

  • Detection and quantification methods

  • Results and conclusions

    • Test Reporting and Certification

    Manufacturers must ensure that their products meet the relevant standards for safety, performance, and quality. Test reports and certification are essential to demonstrate compliance with ISO 18562-4.

    Conclusion

    ISO 18562-4 is a standard that governs the testing of leachable particulates in medical gas pathway devices. Manufacturers must comply with this standard to ensure that their products meet the relevant standards for safety, performance, and quality. Failure to comply can result in regulatory action, product recalls, and damage to reputation.

    Recommendations

    The following recommendations are made:

  • Manufacturers should comply with ISO 18562-4

  • Test reports and certification should be provided to demonstrate compliance with ISO 18562-4

  • Continuous monitoring and testing should be performed to ensure that products meet the relevant standards for safety, performance, and quality.

    • Appendix

    The following appendix provides additional information on:

  • Glossary of terms

  • Abbreviations

  • References

    • This comprehensive guide has provided detailed information on ISO 18562-4 leachable particulates in medical gas pathway devices laboratory testing service provided by Eurolab. The standard is essential for ensuring that medical device manufacturers comply with regulatory requirements and maintain the highest standards of quality, safety, and performance.

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