EUROLAB
iso-10993-18-chemical-characterization-techniques
Biocompatibility Testing ASTM F1609 Evaluation of Surface ContaminationASTM F1904 Protein Adsorption TestingASTM F1980 Accelerated Aging of Medical DevicesASTM F2027 Cytotoxicity EvaluationASTM F2028 Evaluation of Sterilization ResidualsASTM F2052 Magnetically Induced DisplacementASTM F2080 Durability TestingASTM F2095 Evaluation of Additives in Medical PolymersASTM F2096 Particulate TestingASTM F2100 Medical Mask TestingASTM F2130 Endotoxin TestingASTM F2149 Antimicrobial Activity TestingASTM F2180 Sterilization Validation for HydrogelsASTM F2182 RF Induced Heating TestsASTM F2213 Evaluation of Magnetic Resonance CompatibilityASTM F2255 Acute Systemic ToxicityASTM F2273 Cytokine AnalysisASTM F2392 Implant Wear Debris AnalysisASTM F2458 Biofilm Formation TestingASTM F2459 Adhesion of Medical Device CoatingsASTM F2478 Safety Evaluation of PolymersASTM F2503 MR Safety LabelingASTM F2900 Testing of BiopolymersASTM F2941 Shelf Life TestingASTM F640 Extraction of Medical DevicesASTM F748 Evaluation of Medical Device BiocompatibilityASTM F756 Assessment of Hemolytic PropertiesEN ISO 10993-1 Biological Evaluation – Part 1EN ISO 10993-10 Sensitization TestingEN ISO 10993-11 Systemic ToxicityEN ISO 10993-5 Cytotoxicity TestingIEC 60601-1 Safety Requirements for Medical Electrical EquipmentISO 10993-1 Biological Evaluation of Medical DevicesISO 10993-10 Sensitization TestingISO 10993-11 Systemic Toxicity TestingISO 10993-12 Sample Preparation and Reference MaterialsISO 10993-13 Identification and Quantification of Degradation ProductsISO 10993-14 Degradation TestingISO 10993-15 Toxicokinetic StudyISO 10993-16 Toxicokinetic Study ProtocolISO 10993-17 Establishing Allowable LimitsISO 10993-19 Biodegradation TestingISO 10993-2 Animal Welfare RequirementsISO 10993-20 Toxicology Data AnalysisISO 10993-21 Evaluation of Metals and AlloysISO 10993-22 Irradiation of Medical DevicesISO 10993-23 Biological Evaluation of ResidualsISO 10993-24 Toxicological Risk AssessmentISO 10993-25 Genotoxicity in Medical DevicesISO 10993-26 Immunotoxicology TestingISO 10993-27 Implant Material CharacterizationISO 10993-28 Evaluation of Metallic ImplantsISO 10993-29 Extraction ConditionsISO 10993-3 Genotoxicity TestingISO 10993-30 Analytical TechniquesISO 10993-31 Mutagenicity TestingISO 10993-32 Toxicity Tests for Medical PolymersISO 10993-33 Biological Evaluation of Degradation ProductsISO 10993-34 Evaluation of Chemical ResiduesISO 10993-35 Assessment of Extractables and LeachablesISO 10993-36 Nonclinical Safety EvaluationISO 10993-37 Evaluation of Cytokine ReleaseISO 10993-38 Endocrine Disruption TestingISO 10993-39 Evaluation of Material ExtractsISO 10993-4 Hemocompatibility TestingISO 10993-40 Evaluation of HemocompatibilityISO 10993-41 Toxicological Risk Assessment FrameworkISO 10993-42 Assessment of NanomaterialsISO 10993-5 Cytotoxicity TestingISO 10993-6 Local Effects after ImplantationISO 10993-7 Ethylene Oxide ResidualsISO 10993-9 Chemical CharacterizationISO 11135 Ethylene Oxide SterilizationISO 11137 Radiation SterilizationISO 11607 Packaging for Terminally Sterilized DevicesISO 11607-1 Packaging ValidationISO 11607-2 Packaging MaterialsISO 11607-3 Packaging TestingISO 11737-1 Sterilization ValidationISO 11737-2 Microbial Limit TestsISO 11737-3 Bioburden DeterminationISO 13408 Aseptic ProcessingISO 13408-1 Cleanroom TestingISO 13408-2 Aseptic Processing ValidationISO 13485 Quality Management Systems for Medical DevicesISO 13485 Risk Management IntegrationISO 13485-1 Quality System RequirementsISO 14117 Pulse Oximeter PerformanceISO 14155 Clinical Investigation StandardsISO 14155-1 Clinical Trial DesignISO 14155-2 Clinical Trial ConductISO 14160 Biocompatibility for Transfusion EquipmentISO 14161 Sterilization by Ethylene OxideISO 14161 Validation of Sterilization ProcessesISO 14630 Non-active Surgical ImplantsISO 14644 Cleanroom StandardsISO 14708 Active Implantable Medical DevicesISO 14708-3 Active Implantable Device TestingISO 14708-4 Implantable Device SafetyISO 14969 Quality Management for Sterile DevicesISO 14971 Risk Management DocumentationISO 14971 Risk Management for Medical DevicesISO 14971-2 Risk Management ReportingISO 15223 Medical Device SymbolsISO 17025 Testing Laboratory AccreditationISO 18113 Medical Device LabelingISO 18562 Biocompatibility of Breathing Gas PathwaysISO 22442 Medical Device Material TestingISO 25539 Cardiovascular ImplantsISO 25539-2 Coronary StentsISO 7405 Evaluation of Biocompatibility for DentistryISO 80369 Small-Bore ConnectorsUSP <87> Biological Reactivity TestsUSP <88> Tests for Plastic Materials

ISO 10993-18 Chemical Characterization Techniques Laboratory Testing Services

Standard-Related Information

ISO 10993-18 is a standard that outlines the chemical characterization techniques for testing medical devices. This standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices. The standard is published by the International Organization for Standardization (ISO) and is available in several languages.

Why is this Testing Required?

Medical devices are used to diagnose, treat, or prevent diseases in humans. These devices can be made from a variety of materials, including metals, plastics, ceramics, and more. However, these materials can leach chemicals into the body, which can cause adverse reactions or even toxicity.

ISO 10993-18 Chemical Characterization Techniques testing is required to ensure that medical devices are safe for use in humans. This testing helps to identify potential chemical hazards associated with medical device materials, enabling manufacturers to take corrective action and improve product safety.

Legal and Regulatory Framework

The ISO 10993 series of standards is widely adopted by regulatory bodies around the world. In the United States, the FDA (Food and Drug Administration) requires medical devices to comply with ISO 10993-18 testing as part of the pre-market approval process.

In Europe, the European Unions Medical Device Regulation (MDR) also requires compliance with ISO 10993-18 testing for all medical devices. Similarly, in other regions, such as Japan and Australia, regulatory bodies require compliance with ISO 10993-18 testing for medical devices.

Standard Development Organizations

The International Organization for Standardization (ISO) is a non-profit organization that develops and publishes international standards. The ISO 10993 series of standards was developed by Technical Committee TC 194, which is responsible for the development of standards related to biological evaluation of medical devices.

International and National Standards

The following are some examples of international and national standards that apply to ISO 10993-18 Chemical Characterization Techniques testing:

  • ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

  • ISO 10993-17:2019 Biological evaluation of medical devices - Part 17: Tests for in vitro cytotoxicity

  • ASTM F748-10 Standard Practice for Selecting Generic Biological Test Data for Materials and Products

    • Industry-Specific Requirements

    Medical device manufacturers must comply with the relevant national and international standards, including ISO 10993-18. Failure to comply can result in regulatory non-compliance, product recalls, or even lawsuits.

    Standard Compliance Requirements

    To ensure compliance with ISO 10993-18 testing, medical device manufacturers should:

    1. Review the standard requirements and scope

    2. Conduct a risk assessment of their products

    3. Select the relevant tests and methods

    4. Perform the testing according to the standard

    5. Document and report the results

    Standard Requirements and Needs

    Why is ISO 10993-18 Chemical Characterization Techniques Testing Needed?

    ISO 10993-18 Chemical Characterization Techniques testing is essential for ensuring the safety of medical devices. This testing helps to identify potential chemical hazards associated with medical device materials, enabling manufacturers to take corrective action and improve product safety.

    Business and Technical Reasons for Conducting ISO 10993-18 Testing

    Conducting ISO 10993-18 Chemical Characterization Techniques testing has several business and technical reasons:

    1. Compliance: To comply with regulatory requirements

    2. Product Safety: To ensure the safety of medical devices

    3. Risk Assessment: To identify potential chemical hazards associated with medical device materials

    Consequences of Not Performing ISO 10993-18 Testing

    Failure to conduct ISO 10993-18 Chemical Characterization Techniques testing can result in:

    1. Regulatory non-compliance

    2. Product recalls

    3. Lawsuits

    4. Damage to reputation and brand value

    Industries and Sectors Requiring ISO 10993-18 Testing

    Medical device manufacturers, including those producing implants, surgical instruments, diagnostic equipment, and more.

    Risk Factors and Safety Implications

    Chemical hazards associated with medical device materials can cause adverse reactions or even toxicity. This testing helps to identify potential chemical hazards, enabling manufacturers to take corrective action and improve product safety.

    Quality Assurance and Quality Control Aspects

    ISO 10993-18 Chemical Characterization Techniques testing is part of the quality assurance and quality control process. Manufacturers must ensure that their products comply with regulatory requirements and industry standards.

    Why This Test Should be Performed?

    Performing ISO 10993-18 Chemical Characterization Techniques testing has several benefits:

    1. Compliance: To comply with regulatory requirements

    2. Product Safety: To ensure the safety of medical devices

    3. Risk Assessment: To identify potential chemical hazards associated with medical device materials

    Test Conditions and Methodology

    The following are some details about test conditions and methodology for ISO 10993-18 Chemical Characterization Techniques testing:

    1. Materials Selection: The selection of materials for testing is based on the products intended use, design, and composition.

    2. Testing Methods: Testing methods include chemical extraction, ion leach tests, and other relevant techniques.

    3. Sampling Plan: A sampling plan is developed to ensure that the test results are representative of the material.

    Why Choose a Laboratory for ISO 10993-18 Testing?

    Choosing a laboratory with expertise in ISO 10993-18 Chemical Characterization Techniques testing ensures:

    1. Compliance: Compliance with regulatory requirements

    2. Product Safety: Ensures the safety of medical devices

    3. Risk Assessment: Identifies potential chemical hazards associated with medical device materials

    Certification and Accreditation

    Look for a laboratory that is certified to ISO/IEC 17025:2017 (General Requirements for the Competence of Testing and Calibration Laboratories) and accredited by a recognized accreditation body.

    Conclusion

    ISO 10993-18 Chemical Characterization Techniques testing is an essential part of ensuring the safety of medical devices. By following this standard, manufacturers can ensure compliance with regulatory requirements and industry standards, while also identifying potential chemical hazards associated with their products.

    At Your Laboratory, we offer expert ISO 10993-18 Chemical Characterization Techniques testing services to help you comply with regulatory requirements and improve product safety.

    References

  • ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

  • ISO 10993-17:2019 Biological evaluation of medical devices - Part 17: Tests for in vitro cytotoxicity

  • ASTM F748-10 Standard Practice for Selecting Generic Biological Test Data for Materials and Products

    • This comprehensive guide covers all aspects of ISO 10993-18 Chemical Characterization Techniques testing, including standard-related information, why this testing is required, regulatory framework, and how to choose a laboratory for testing.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers