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iso-18562-2-volatile-organic-compounds-testing-from-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 10993-13 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 18562-3 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 18562-2 Volatile Organic Compounds Testing from Medical Devices Laboratory Testing Service Provided by Eurolab

ISO 18562-2 is a comprehensive standard that governs the testing of volatile organic compounds (VOCs) from medical devices. This standard is developed and published by the International Organization for Standardization (ISO) in collaboration with other standard development organizations (SDOs). The standard is applicable to all medical device manufacturers, suppliers, and regulators who need to ensure the safety and quality of their products.

Legal and Regulatory Framework

The testing of VOCs from medical devices is governed by various national and international regulations. In the European Union (EU), for example, Directive 2011/65/EU on the Restriction of Hazardous Substances (RoHS) sets limits on the concentration of certain hazardous substances, including VOCs, in electrical and electronic equipment, including medical devices. The Medical Device Regulation (MDR) 2017/745 also requires manufacturers to ensure that their products comply with the relevant standards, including ISO 18562-2.

International and National Standards

The following international and national standards apply to the testing of VOCs from medical devices:

  • ISO 18562-2:2019(E) - Volatile organic compounds (VOCs): Part 2: Sampling method for determining the presence of extractable fluorinated substances in materials used in medical devices

  • ISO 11135:2009 - Sterilization of health care products Ethylene oxide Requirements for development, validation and routine control of a sterilization process

  • IEC 62304:2006/A1:2015 - Medical device software Software life-cycle processes

    • Standard Development Organizations

    SDOs play a crucial role in developing and maintaining standards. The main SDOs involved in the development of ISO 18562-2 are:

  • International Organization for Standardization (ISO)

  • European Committee for Electrotechnical Standardization (CENELEC)

  • Deutsches Institut für Normung e.V. (DIN)

    • Evolution of Standards

    Standards evolve and get updated to reflect changes in technology, regulations, and industry practices. The development process involves a series of steps, including:

    1. Needs assessment

    2. Literature review

    3. Drafting the standard

    4. Balloting and comments

    5. Finalization and publication

    Standard Numbers and Scope

    The following standard numbers and scope apply to the testing of VOCs from medical devices:

  • ISO 18562-2:2019(E) - Volatile organic compounds (VOCs): Part 2: Sampling method for determining the presence of extractable fluorinated substances in materials used in medical devices

  • Scope: The standard specifies a sampling method for determining the presence of extractable fluorinated substances in materials used in medical devices.

    • Standard Compliance Requirements

    Compliance with ISO 18562-2 is mandatory for all medical device manufacturers, suppliers, and regulators who need to ensure the safety and quality of their products. Non-compliance can result in regulatory fines, product recalls, and damage to reputation.

    Why This Test Is Needed

    The testing of VOCs from medical devices is essential for ensuring the safety and quality of these products. The test helps to:

  • Identify potential health risks associated with VOC emissions

  • Ensure compliance with regulatory requirements

  • Verify product performance and reliability

  • Prevent product recalls and damage to reputation

    • Business and Technical Reasons

    Conducting ISO 18562-2 testing provides numerous business and technical benefits, including:

  • Reduced risk of product liability and regulatory fines

  • Improved product quality and performance

  • Enhanced customer confidence and trust

  • Increased market access and trade facilitation

  • Compliance with international and national regulations

    • Consequences of Not Performing This Test

    Failure to conduct ISO 18562-2 testing can result in severe consequences, including:

  • Regulatory fines and penalties

  • Product recalls and damage to reputation

  • Loss of customer confidence and trust

  • Reduced market access and trade facilitation

    • Industries and Sectors That Require This Testing

    The following industries and sectors require the testing of VOCs from medical devices:

  • Medical device manufacturers

  • Suppliers of materials used in medical devices

  • Regulators and certification bodies

  • Healthcare providers and users of medical devices

    • Risk Factors and Safety Implications

    The testing of VOCs from medical devices helps to mitigate risks associated with VOC emissions, including:

  • Health risks to patients and healthcare workers

  • Environmental impacts and pollution

  • Product performance and reliability issues

    • Quality Assurance and Quality Control Aspects

    Conducting ISO 18562-2 testing ensures compliance with quality assurance and quality control requirements, including:

  • Verification of product performance and reliability

  • Validation of processes and systems

  • Monitoring and control of VOC emissions

    • Why This Test Is Needed

    The testing of VOCs from medical devices is essential for ensuring the safety and quality of these products. The test helps to:

  • Identify potential health risks associated with VOC emissions

  • Ensure compliance with regulatory requirements

  • Verify product performance and reliability

  • Prevent product recalls and damage to reputation

    • Business and Technical Reasons

    Conducting ISO 18562-2 testing provides numerous business and technical benefits, including:

  • Reduced risk of product liability and regulatory fines

  • Improved product quality and performance

  • Enhanced customer confidence and trust

  • Increased market access and trade facilitation

  • Compliance with international and national regulations

    • Consequences of Not Performing This Test

    Failure to conduct ISO 18562-2 testing can result in severe consequences, including:

  • Regulatory fines and penalties

  • Product recalls and damage to reputation

  • Loss of customer confidence and trust

  • Reduced market access and trade facilitation

    • Industries and Sectors That Require This Testing

    The following industries and sectors require the testing of VOCs from medical devices:

  • Medical device manufacturers

  • Suppliers of materials used in medical devices

  • Regulators and certification bodies

  • Healthcare providers and users of medical devices

    • Risk Factors and Safety Implications

    The testing of VOCs from medical devices helps to mitigate risks associated with VOC emissions, including:

  • Health risks to patients and healthcare workers

  • Environmental impacts and pollution

  • Product performance and reliability issues

    • Quality Assurance and Quality Control Aspects

    Conducting ISO 18562-2 testing ensures compliance with quality assurance and quality control requirements, including:

  • Verification of product performance and reliability

  • Validation of processes and systems

  • Monitoring and control of VOC emissions

    • Testing Process and Procedure

    The testing process involves the following steps:

    1. Sample preparation

    2. Sampling

    3. Analysis

    4. Data interpretation and reporting

    Equipment and Materials Required

    The equipment and materials required for conducting ISO 18562-2 testing include:

  • Sample containers and preparation equipment

  • Sampling instruments (e.g., syringes, pipettes)

  • Analytical equipment (e.g., gas chromatography-mass spectrometry)

  • Data analysis software

    • Personnel Qualifications and Training

    The personnel involved in conducting ISO 18562-2 testing should have the following qualifications and training:

  • Basic knowledge of VOCs and their properties

  • Familiarity with sampling and analytical techniques

  • Understanding of regulatory requirements and standards

  • Training in data interpretation and reporting

    • Testing Frequency and Schedule

    The frequency and schedule for conducting ISO 18562-2 testing depend on various factors, including:

  • Type and complexity of medical devices

  • Regulatory requirements and industry practices

  • Product performance and reliability issues

    • Record Keeping and Documentation

    Conducting ISO 18562-2 testing requires maintaining accurate records and documentation, including:

  • Sample preparation and analysis reports

  • Data interpretation and reporting documents

  • Quality control and quality assurance records

    • Conclusion

    The testing of VOCs from medical devices is essential for ensuring the safety and quality of these products. Conducting ISO 18562-2 testing provides numerous benefits, including reduced risk of product liability and regulatory fines, improved product quality and performance, enhanced customer confidence and trust, increased market access and trade facilitation, and compliance with international and national regulations.

    References

  • ISO 18562-2:2019(E) - Volatile organic compounds (VOCs): Part 2: Sampling method for determining the presence of extractable fluorinated substances in materials used in medical devices

  • IEC 62304:2006/A1:2015 - Medical device software Software life-cycle processes

  • European Committee for Electrotechnical Standardization (CENELEC)

  • Deutsches Institut für Normung e.V. (DIN)

    • Appendix

    The following appendix provides additional information on the testing of VOCs from medical devices:

  • Sample preparation and analysis protocols

  • Data interpretation and reporting guidelines

  • Quality control and quality assurance procedures

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