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iso-11979-5-extractables-in-intraocular-lens-materials
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 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 11979-5 Extractables in Intraocular Lens Materials Laboratory Testing Service

Standard-Related Information

ISO 11979-5 is a standard that specifies the requirements for the testing of extractables from intraocular lens materials. The standard is published by the International Organization for Standardization (ISO) and is part of the ISO 11979 series, which deals with ophthalmic optics.

Overview of Relevant Standards

  • ISO 11979-5:2017 - Ophthalmic optics - Intraocular lenses - Part 5: Extractables

  • ASTM F2849-14 - Standard Practice for Assessing Extractable Materials from Biomaterials Used in Medical Devices

  • EN ISO 11782:2009 - Ophthalmic optics - Intraocular lenses - Part 2: Determination of refractive power

  • TSE 1234 - Turkish Standard for Ophthalmic Optics - Intraocular Lenses

    • Legal and Regulatory Framework

    The testing of extractables from intraocular lens materials is regulated by various laws and regulations, including:

  • EU Medical Device Regulation (MDR) 2017/745

  • US FDA 21 CFR Part 820 - Quality System Regulation

  • ISO 13485:2016 - Medical devices - Quality management systems

    • Standard Development Organizations

    The development of standards for ophthalmic optics is carried out by various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • International and National Standards

    The following international and national standards are relevant to ISO 11979-5:

  • ISO 11979 series: Ophthalmic optics - Intraocular lenses

  • ASTM F2849: Standard Practice for Assessing Extractable Materials from Biomaterials Used in Medical Devices

  • EN ISO 11782:2009: Ophthalmic optics - Intraocular lenses - Part 2: Determination of refractive power

    • Standard Compliance Requirements

    Compliance with relevant standards is mandatory for manufacturers and suppliers of intraocular lens materials. Failure to comply can result in:

  • Product recall

  • Quality assurance and quality control issues

  • Regulatory non-compliance

  • Loss of market share and reputation

    • Standard Evolution and Update

    Standards are regularly reviewed and updated to reflect changes in technology, regulatory requirements, and industry best practices.

    Specific Standard Numbers and Scope

    The following standard numbers and scope are relevant to ISO 11979-5:

  • ISO 11979-5:2017 - Ophthalmic optics - Intraocular lenses - Part 5: Extractables

  • ASTM F2849-14 - Standard Practice for Assessing Extractable Materials from Biomaterials Used in Medical Devices

    • Standard Compliance Requirements for Different Industries

    Compliance with relevant standards is mandatory for manufacturers and suppliers of intraocular lens materials across various industries, including:

  • Medical devices

  • Ophthalmic optics

  • Biomedical engineering

  • Pharmaceutical industry

    • Standard-Related Risks and Consequences

    Failure to comply with relevant standards can result in:

  • Product recall

  • Quality assurance and quality control issues

  • Regulatory non-compliance

  • Loss of market share and reputation

  • Safety and efficacy risks for patients

    • Business and Technical Reasons for Conducting ISO 11979-5 Extractables in Intraocular Lens Materials Testing

    The testing of extractables from intraocular lens materials is essential to ensure product safety, quality, and regulatory compliance.

    Consequences of Not Performing this Test

    Failure to conduct this test can result in:

  • Quality assurance and quality control issues

  • Regulatory non-compliance

  • Safety and efficacy risks for patients

  • Loss of market share and reputation

    • Industries and Sectors that Require this Testing

    The following industries and sectors require this testing:

  • Medical devices

  • Ophthalmic optics

  • Biomedical engineering

  • Pharmaceutical industry

    • Risk Factors and Safety Implications

    The risk factors and safety implications associated with intraocular lens materials include:

  • Toxicity and biocompatibility issues

  • Material degradation and instability

  • Sterilization and packaging issues

  • Quality control and assurance problems

    • Quality Assurance and Quality Control Aspects

    The quality assurance and quality control aspects of this testing include:

  • Sampling and preparation procedures

  • Testing parameters and conditions

  • Measurement and analysis methods

  • Calibration and validation procedures

  • Data collection and recording procedures

    • Contribution to Product Safety and Reliability

    This testing contributes significantly to product safety and reliability by:

  • Ensuring the absence of toxic substances in intraocular lens materials

  • Verifying material stability and biocompatibility

  • Confirming compliance with regulatory requirements

    • Competitive Advantages of Having this Testing Performed

    The competitive advantages of having this testing performed include:

  • Improved product quality and reliability

  • Enhanced safety and efficacy for patients

  • Compliance with regulatory requirements

  • Increased market share and reputation

    • Testing Parameters and Conditions

    The following testing parameters and conditions are relevant to ISO 11979-5:

  • Sampling and preparation procedures

  • Testing apparatus and equipment

  • Measurement and analysis methods

  • Calibration and validation procedures

    • Measurement and Analysis Methods

    The measurement and analysis methods used in this testing include:

  • Spectroscopy and chromatography techniques

  • Microscopic examination and SEM/EDS analysis

  • Chemical and biological assays

    • Calibration and Validation Procedures

    The calibration and validation procedures for this testing include:

  • Regular calibration of equipment and instruments

  • Validation of testing protocols and procedures

  • Data analysis and reporting

    • Data Collection and Recording Procedures

    The data collection and recording procedures used in this testing include:

  • Accurate and precise measurement of extractables

  • Detailed documentation of testing results and findings

  • Electronic records and reporting

    • Conclusion

    In conclusion, the testing of extractables from intraocular lens materials is essential to ensure product safety, quality, and regulatory compliance. Compliance with relevant standards is mandatory for manufacturers and suppliers of intraocular lens materials across various industries.

    ---

    Please note that this comprehensive guide is a general overview of ISO 11979-5 Extractables in Intraocular Lens Materials Laboratory Testing Service and should not be considered as a replacement for specific testing protocols or procedures. For detailed information, please consult the relevant standards and regulatory requirements.

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