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iso-18562-evaluation-of-organic-compounds-in-medical-devices
Organic Contaminant Residue Analysis ASTM D3278 Analysis of Organic Contaminants in Petroleum ProductsASTM D4867 Detection of Organic Residues in Industrial EffluentsASTM D5313 Organic Contaminants in Water and WastewaterASTM D5511 Anaerobic Biodegradation of Organic CompoundsASTM D5541 Measurement of Organic Compounds in Environmental SamplesASTM D5835 Determination of Organic Contaminants in SoilASTM D5837 Detection of Organic Contaminants in WastewaterASTM D5847 Detection of Organic Contaminants in WastewaterASTM D5849 Analysis of Organic Contaminants in WaterASTM D6139 Analysis of Organic Contaminants in Food and BeverageASTM D6245 Measurement of Organic Vapors in Indoor AirASTM D6245 Measurement of Organic Vapors in Indoor AirASTM D6323 Analysis of Organic Contaminants in Drinking WaterASTM D6528 Organic Contaminants in Aqueous SamplesASTM D6584 Detection of Organic Contaminants in WastewaterASTM D6594 Organic Contaminants in Soil and SedimentASTM D6786 Analysis of Organic Contaminants in Drinking WaterASTM D6839 Analysis of Organic Contaminants in Soil and WaterASTM D6890 Organic Contaminants by GC/MS in Environmental SamplesASTM D7575 Screening of Organic Contaminants in SoilASTM D7578 Analysis of Organic Residues in SoilEN 12341 Determination of Organic Particulate Matter in AirEN 12341 Determination of Organic Particulate Matter in AirEN 12341 Organic Contaminant Sampling in WaterEN 12341 Sampling and Analysis of Organic Particulate MatterEN 12856 Determination of Organic Contaminants in FoodstuffsEN 13284 Determination of Organic Particulate MatterEN 13697 Detection of Organic Contaminants in SurfacesEN 14345 Measurement of Organic Contaminants in WasteEN 14347 Determination of Organic Contaminants in FoodEN 14387 Test Method for Organic Vapour Air-Purifying RespiratorsEN 14907 Determination of Organic Contaminants in Food PackagingEN 15662 Determination of Pesticide Residues by QuEChERS MethodEN 16190 Determination of Organic Contaminants in FoodEN ISO 10272 Analysis of Organic Contaminants in Animal ProductsEN ISO 12856 Determination of Organic Residues in FoodEN ISO 15705 Analysis of Organic Compounds in Drinking WaterEN ISO 15768 Analysis of Organic Compounds in WaterEN ISO 16190 Analysis of Organic Contaminants in FoodEN ISO 16190 Measurement of Organic Contaminants in FoodEN ISO 16994 Determination of Organic Contaminants in SoilsEN ISO 21727 Characterization of Organic Contaminants in WastewaterEPA Method 1624 Determination of Organic Pollutants in WastewaterEPA Method 1631E Determination of Organic Contaminants in WaterEPA Method 1664B Measurement of Oil and Grease Organic ResiduesEPA Method 1694 Pharmaceuticals and Organic Contaminants in WaterEPA Method 3565 Determination of Organic Contaminants by GC/MSEPA Method 3580 Extraction of Organic Contaminants from SoilEPA Method 3640 Measurement of Organic Compounds in WastewaterEPA Method 5021A VOCs Sampling and AnalysisEPA Method 524.2 VOCs Analysis in Drinking WaterEPA Method 525.2 Organic Compounds in Drinking WaterEPA Method 525.3 Measurement of Organic Compounds in Drinking WaterEPA Method 528 Determination of Organic Contaminants in WaterEPA Method 601 Organic Contaminants by Gas ChromatographyEPA Method 624 Determination of Organic Compounds in WaterEPA Method 8260B VOCs by Gas ChromatographyEPA Method 8260C VOCs by GC/MSEPA Method 8270B Semivolatile Organic Compounds by GC/MSEPA Method 8270C Semivolatile Organic Compounds AnalysisEPA Method 8270D Semi-Volatile Organic Compounds by GC/MSEPA Method 8270E Semivolatile Organic Compounds AnalysisEPA Method 8270F Semivolatile Organic Compounds by GC/MSEPA Method 8270G Semivolatile Organic Compound AnalysisISO 11074-3 Water Quality – Sampling of Organic ContaminantsISO 11269-2 Soil Quality – Organic Contaminant BioassaysISO 11277 Soil Quality – Organic Carbon DeterminationISO 13828 Analysis of Organic Contaminants in SoilISO 13877 Determination of Polycyclic Aromatic Hydrocarbons in SoilISO 16000-6 Indoor Air Quality – VOC Sampling and AnalysisISO 16000-9 Indoor Air – Determination of Organic ContaminantsISO 17011 Conformity Assessment for Organic Contaminant TestingISO 17025 Accredited Organic Contaminant Residue AnalysisISO 17025 Accredited Testing for Organic ContaminantsISO 17034 Reference Materials for Organic ContaminantsISO 17043 Proficiency Testing for Organic Contaminant LabsISO 17075 Paints and Varnishes – Organic Solvent Residue TestingISO 18400 Soil Sampling for Organic Contaminant AnalysisISO 18562 Biocompatibility Testing for Medical Device Organic ContaminantsISO 18562-2 Biocompatibility Testing for Organic ContaminantsISO 18562-3 Biocompatibility – Testing for Organic Volatile CompoundsISO 18562-4 Evaluation of Organic Extractables in Medical DevicesISO 18593 Surface Sampling for Organic ContaminantsISO 22000 Food Safety Management for Organic ContaminantsISO 5667-3 Water Sampling – Handling for Organic Contaminants

Comprehensive Guide to ISO 18562 Evaluation of Organic Compounds in Medical Devices Laboratory Testing Service

Provided by Eurolab: Your Partner for Reliable and Accurate Testing Services

ISO 18562 is a widely recognized standard that governs the evaluation of organic compounds in medical devices. The standard is developed by the International Organization for Standardization (ISO) and is based on the principles of risk management and quality assurance.

Relevant Standards

The following standards are relevant to ISO 18562 Evaluation of Organic Compounds in Medical Devices testing:

  • ISO 10993-18: Biological evaluation of medical devicesPart 18: Chemical characterization of materials

  • ASTM F2024: Standard Practice for Evaluating the Biocompatibility of Surgical Implants and Medical Materials

  • EN ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation of primary biological reactions in biological systems

  • TSE EN ISO 10993-5: Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

    • These standards provide a framework for the evaluation of organic compounds in medical devices, ensuring that materials used in medical applications meet stringent safety and performance requirements.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 18562 Evaluation of Organic Compounds in Medical Devices testing is governed by various national and international regulations. Some key regulations include:

  • EU Medical Device Regulation (MDR): Imposes strict requirements for the evaluation of medical devices, including materials and substances used in their manufacture.

  • US FDA 21 CFR Part 880: Establishes guidelines for the evaluation of orthopedic and neurological devices, including requirements for material safety and performance.

  • Medical Device Regulations (EU) 2017/745: Mandates the implementation of a risk management process for medical devices, including the evaluation of organic compounds.

    • Standard Development Organizations

    Standard development organizations (SDOs) play a critical role in developing and maintaining standards. Some key SDOs include:

  • International Organization for Standardization (ISO): Develops and publishes international standards.

  • American Society for Testing and Materials (ASTM): Develops and publishes standards for materials, products, and services.

  • Deutsches Institut für Normung (DIN): Develops and publishes German national standards.

    • International and National Standards

    International and national standards that apply to ISO 18562 Evaluation of Organic Compounds in Medical Devices testing include:

  • ISO 10993-18: Biological evaluation of medical devicesPart 18: Chemical characterization of materials

  • EN ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation of primary biological reactions in biological systems

    • Standard Compliance Requirements

    Compliance with standards is essential for ensuring the safety and performance of medical devices. Industries that require compliance include:

  • Medical Device Industry: Manufacturers of medical devices must comply with regulatory requirements, including those related to material safety and performance.

  • Pharmaceutical Industry: Manufacturers of pharmaceuticals must comply with regulations related to material safety and performance.

    • ISO 18562 Evaluation of Organic Compounds in Medical Devices testing is essential for ensuring the safety and performance of medical devices. This test is required due to the following reasons:

    Business and Technical Reasons

  • Material Safety: The evaluation of organic compounds in medical devices ensures that materials used meet stringent safety requirements.

  • Performance Requirements: Testing ensures that materials used in medical devices meet performance requirements, including durability and biocompatibility.

    • Consequences of Not Performing This Test

    Failure to perform this test can result in:

  • Non-Compliance with Regulations: Medical devices may not comply with regulatory requirements, leading to potential recalls or fines.

  • Safety Risks: Inadequate testing may expose patients to safety risks associated with medical device malfunction.

    • Industries and Sectors that Require This Testing

    Industries and sectors that require this testing include:

  • Medical Device Industry

  • Pharmaceutical Industry

    • ISO 18562 Evaluation of Organic Compounds in Medical Devices testing involves a comprehensive evaluation of materials used in medical devices. The test is conducted using the following methods:

    Testing Equipment and Instruments

    The following equipment and instruments are used for testing:

  • Gas Chromatography-Mass Spectrometry (GC-MS)

  • High-Performance Liquid Chromatography (HPLC)

    • Sample Preparation Procedures

    Sample preparation procedures include:

  • Extraction: Organic compounds are extracted from materials using solvents or other extraction methods.

  • Purification: Extracted organic compounds are purified to ensure accuracy and reliability.

    • Testing Parameters and Conditions

    Testing parameters and conditions include:

  • Temperature: Materials are exposed to varying temperatures to simulate real-world usage scenarios.

  • Humidity: Materials are exposed to different humidity levels to assess their performance in various environments.

    • Test Report and Certification

    A comprehensive test report is generated after completing the testing process. The report includes:

  • Test Results: Data from GC-MS or HPLC analysis, including peak areas and retention times.

  • Conclusion: Summary of test results, including any observations or recommendations for improvement.

    • Certification is awarded to medical devices that meet regulatory requirements, including those related to material safety and performance.

    Your Partner for Reliable and Accurate Testing Services

    Eurolab offers comprehensive testing services, including ISO 18562 Evaluation of Organic Compounds in Medical Devices testing. Our team of experts ensures accurate and reliable results, ensuring compliance with regulatory requirements and industry standards. Contact us today to learn more about our services!

    Compliance with Regulations

    Our expertise in testing services helps you comply with regulations, including those related to material safety and performance.

    Reliable Results

    We ensure accurate and reliable test results using state-of-the-art equipment and instruments.

    Certification

    Medical devices that meet regulatory requirements are certified by us, ensuring compliance with industry standards.

    Industry-Specific Solutions

    Our testing services cater to various industries, including medical device and pharmaceuticals.

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