EUROLAB
iso-10993-21-evaluation-of-metals-and-alloys
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 10993-18 Chemical Characterization TechniquesISO 10993-19 Biodegradation TestingISO 10993-2 Animal Welfare RequirementsISO 10993-20 Toxicology Data AnalysisISO 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

Comprehensive Guide to ISO 10993-21 Evaluation of Metals and Alloys Laboratory Testing Service Provided by Eurolab

ISO 10993-21 is a standard developed by the International Organization for Standardization (ISO) to evaluate the biocompatibility of metals and alloys. This standard is part of the ISO 10993 series, which provides guidelines for testing the biocompatibility of medical devices.

Legal and Regulatory Framework

The ISO 10993-21 standard is designed to ensure that medical devices made from metals and alloys are safe for use in humans. The standard is based on the principles of risk management, which involves identifying potential risks associated with a device and implementing measures to mitigate those risks.

International and National Standards

The ISO 10993-21 standard is a harmonized standard that is accepted by many countries around the world. However, each country may have its own national standards and regulations governing the use of metals and alloys in medical devices. For example:

  • In the European Union (EU), the relevant standards are EN ISO 10993-21 and EU Directive 2004/27/EC.

  • In the United States (US), the relevant standard is ASTM F748-16, which is identical to ISO 10993-21.

    • Standard Development Organizations

    The ISO 10993 series of standards was developed by Technical Committee 194 (TC 194) of the International Organization for Standardization. TC 194 is responsible for developing and maintaining standards related to biocompatibility testing.

    How Standards Evolve and Get Updated

    Standards are continually reviewed and updated to reflect new scientific knowledge, changes in technology, and evolving regulatory requirements. For example:

  • ISO 10993-21 was first published in 2006 and has since been revised in 2019.

  • The standard is reviewed every five years by TC 194 to ensure that it remains relevant and effective.

    • Standard Numbers and Scope

    The scope of ISO 10993-21 includes the evaluation of metals and alloys used in medical devices, including:

  • Implantable devices (e.g., pacemakers, joint replacements)

  • Non-implantable devices (e.g., diagnostic equipment, surgical instruments)

    • Specific standard numbers include:

  • ISO 10993-1:2009(E) - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ISO 10993-10:2015 - Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

    • Standard Compliance Requirements

    Compliance with ISO 10993-21 is mandatory for medical device manufacturers who wish to market their products in countries that accept the standard. Non-compliance can result in product recalls, fines, and damage to a companys reputation.

    In summary, ISO 10993-21 is an essential standard for evaluating the biocompatibility of metals and alloys used in medical devices. Compliance with this standard ensures that medical devices are safe for use in humans and helps protect consumers from potential health risks.

    Why is ISO 10993-21 Evaluation of Metals and Alloys testing necessary?

  • To ensure the safety of patients who use medical devices made from metals and alloys

  • To comply with regulatory requirements, such as EU Directive 2004/27/EC and ASTM F748-16

  • To mitigate potential risks associated with device failure or contamination

    • Business and Technical Reasons

    Conducting ISO 10993-21 Evaluation of Metals and Alloys testing is essential for medical device manufacturers who wish to:

  • Maintain customer trust and confidence in their products

  • Comply with regulatory requirements and avoid fines and penalties

  • Reduce the risk of product recalls and damage to their reputation

    • Consequences of Not Performing This Test

    Failure to perform ISO 10993-21 Evaluation of Metals and Alloys testing can result in:

  • Product recalls due to device failure or contamination

  • Fines and penalties for non-compliance with regulatory requirements

  • Damage to a companys reputation and loss of customer trust

    • Industries and Sectors That Require This Testing

    Medical device manufacturers who use metals and alloys in their products are required to conduct ISO 10993-21 Evaluation of Metals and Alloys testing, including:

  • Orthopedic companies (e.g., joint replacements, bone screws)

  • Cardiovascular companies (e.g., pacemakers, stents)

  • Diagnostic equipment manufacturers

    • Risk Factors and Safety Implications

    ISO 10993-21 Evaluation of Metals and Alloys testing is essential for mitigating potential risks associated with device failure or contamination, including:

  • Allergic reactions to metals and alloys

  • Toxicity from metal ions released by devices

  • Device failure due to corrosion or degradation

    • Quality Assurance and Quality Control Aspects

    ISO 10993-21 Evaluation of Metals and Alloys testing is essential for ensuring the quality and safety of medical devices. This includes:

  • Identifying potential risks associated with device use

  • Implementing measures to mitigate those risks

  • Conducting regular audits and inspections to ensure compliance with regulatory requirements

    • In summary, ISO 10993-21 Evaluation of Metals and Alloys testing is a critical requirement for medical device manufacturers who wish to ensure the safety and quality of their products.

    Eurolab provides a comprehensive laboratory testing service for evaluating the biocompatibility of metals and alloys used in medical devices. Our expert team uses state-of-the-art equipment and follows rigorous testing protocols to ensure that our clients products meet regulatory requirements.

    Our Laboratory Testing Services

    Our laboratory offers a range of testing services, including:

  • Biological evaluation (e.g., cell culture tests, animal studies)

  • Chemical analysis (e.g., elemental analysis, surface characterization)

  • Physical testing (e.g., tensile strength, corrosion resistance)

    • Benefits of Working with Eurolab

    By partnering with Eurolab, our clients can benefit from:

  • Expertise in biocompatibility testing

  • State-of-the-art equipment and facilities

  • Fast turnaround times and competitive pricing

    • In summary, Eurolab is a leading provider of laboratory testing services for evaluating the biocompatibility of metals and alloys used in medical devices. Our expert team and state-of-the-art equipment ensure that our clients products meet regulatory requirements.

    Conclusion

    ISO 10993-21 Evaluation of Metals and Alloys testing is an essential requirement for medical device manufacturers who wish to ensure the safety and quality of their products. By partnering with Eurolab, our clients can benefit from expert knowledge, state-of-the-art equipment, and fast turnaround times.

    Please contact us today to learn more about our laboratory testing services and how we can help you comply with regulatory requirements.

    References

    1. ISO 10993-21:2019 - Biological evaluation of medical devices Part 21: Tests for biocompatibility

    2. EU Directive 2004/27/EC - Medical devices

    3. ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

    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