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iso-10993-12-sample-preparation-for-extractables-testing
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 10993-13 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 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 10993-12 Sample Preparation for Extractables Testing: Eurolabs Laboratory Testing Service

Iso 10993-12 sample preparation for extractables testing is a laboratory test that evaluates the potential of medical devices and equipment to leach chemicals into the body. This test is governed by international standards, including ISO 10993-12, ASTM F748-08, EN ISO 10993-1:2009, TSE EN ISO 10993-1:2014, and others.

The legal and regulatory framework surrounding this testing service is complex and constantly evolving. Medical devices and equipment must comply with various regulations, including the EUs MDR (Medical Device Regulation) and FDAs 510(k) clearance process in the US. Non-compliance can result in costly recalls, fines, and even product bans.

International standards that apply to ISO 10993-12 sample preparation for extractables testing include:

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

  • ASTM F748-08 - Standard Practice for Selecting Generic Biological Test Values for the Testing of Medical Devices

  • EN ISO 10993-1:2009 - Biological evaluation of medical devices -- Part 1: Evaluation and testing (EU)

    • Standard development organizations, such as ISO, IEC, and ASTM, play a crucial role in developing and maintaining standards. These organizations involve industry experts, regulatory bodies, and other stakeholders to ensure that standards are up-to-date and relevant.

    Standards evolve and get updated periodically to reflect new scientific knowledge, technological advancements, or changes in regulations. For example, the latest revision of ISO 10993-1 (2018) includes new guidelines for testing nanomaterials and biodegradable materials.

    Standard compliance requirements vary depending on the industry and region. Medical devices and equipment must comply with specific standards, such as ISO 10993-12, to ensure safety and efficacy.

    ISO 10993-12 sample preparation for extractables testing is a critical test that helps manufacturers ensure their products are safe for use on or in the human body. This test is essential for medical devices and equipment that come into direct contact with the skin, mucous membranes, or other sensitive tissues.

    The business and technical reasons for conducting ISO 10993-12 sample preparation for extractables testing include:

  • Ensuring product safety and efficacy

  • Compliance with regulations and standards

  • Avoiding costly recalls and fines

  • Building customer trust and confidence

  • Enhancing product reputation and market competitiveness

    • Consequences of not performing this test can be severe, including:

  • Product bans or recalls

  • Fines and penalties

  • Loss of market share and revenue

  • Damage to brand reputation and customer trust

    • This testing is required for various industries, including medical devices, pharmaceuticals, cosmetics, and textiles. The risk factors and safety implications associated with this test are significant, as medical devices and equipment can cause harm or even life-threatening conditions if not properly tested.

    Iso 10993-12 sample preparation for extractables testing involves a series of laboratory tests that evaluate the potential of medical devices and equipment to leach chemicals into the body. The test is conducted according to standard procedures, including:

    1. Sample selection and preparation

    2. Extraction and analysis

    3. Testing parameters and conditions

    4. Measurement and analysis methods

    5. Calibration and validation procedures

    The testing environment requires specific conditions, including temperature, humidity, and pressure control. Samples are prepared in accordance with standard protocols, and the extraction process involves using solvents to extract potential leachables.

    Measurement and analysis methods involve various techniques, such as HPLC (High-Performance Liquid Chromatography), GC-MS (Gas Chromatography-Mass Spectrometry), and ICP-MS (Inductively Coupled Plasma Mass Spectrometry).

    Calibration and validation procedures ensure the accuracy and reliability of test results. Quality control measures are implemented throughout the testing process to maintain data integrity.

    Iso 10993-12 sample preparation for extractables testing generates a comprehensive report that includes:

    1. Test methodology and conditions

    2. Sample characteristics and preparation

    3. Extraction and analysis results

    4. Testing parameters and conditions

    5. Measurement and analysis methods

    6. Calibration and validation procedures

    The report format is structured according to standard requirements, including ISO 10993-12 and ASTM F748-08.

    Test results are interpreted in accordance with regulatory guidelines and industry standards. Certification and accreditation aspects involve verifying the competence of testing laboratories, such as Eurolab.

    Traceability and documentation requirements ensure that test data is accurately recorded and maintained for future reference.

    Iso 10993-12 sample preparation for extractables testing is a critical component of medical device and equipment development. This test helps manufacturers ensure product safety, efficacy, and compliance with regulations and standards.

    Benefits of this testing include:

    1. Ensuring product safety and efficacy

    2. Compliance with regulations and standards

    3. Avoiding costly recalls and fines

    4. Building customer trust and confidence

    5. Enhancing product reputation and market competitiveness

    Conclusion

    Iso 10993-12 sample preparation for extractables testing is a comprehensive laboratory test that evaluates the potential of medical devices and equipment to leach chemicals into the body. This test is governed by international standards, including ISO 10993-12, ASTM F748-08, EN ISO 10993-1:2009, TSE EN ISO 10993-1:2014, and others.

    Manufacturers must comply with specific regulations and standards to ensure product safety and efficacy. The consequences of not performing this test can be severe, including product bans or recalls, fines, penalties, loss of market share and revenue, and damage to brand reputation and customer trust.

    Eurolabs laboratory testing service for ISO 10993-12 sample preparation for extractables testing provides manufacturers with a reliable and accredited solution for ensuring product safety and efficacy.

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