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iso-10993-23-biological-evaluation-of-residuals
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 10993-21 Evaluation of Metals and AlloysISO 10993-22 Irradiation of Medical DevicesISO 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 10993-23 Biological Evaluation of Residuals: Eurolabs Laboratory Testing Service

As a leading provider of laboratory testing services, Eurolab is committed to delivering accurate and reliable results for the Biological Evaluation of Residuals (BER) testing according to ISO 10993-23. This article will serve as a comprehensive guide to understanding the importance, requirements, and process of BER testing, as well as why Eurolab is the ideal partner for this service.

The Biological Evaluation of Residuals (BER) testing is governed by ISO 10993-23, which is part of the larger ISO 10993 series. This standard outlines the requirements for evaluating the biological safety of medical devices and materials, including residual substances that may be present in the device or material.

Legal and Regulatory Framework

The legal and regulatory framework surrounding BER testing is complex and multifaceted. In the European Union (EU), the Medical Device Regulation (MDR) requires manufacturers to conduct BER testing for their products to ensure compliance with EU regulations.

In the United States, the FDAs Center for Devices and Radiological Health (CDRH) also requires manufacturers to demonstrate the safety of their devices through BER testing.

International and National Standards

The following standards apply to BER testing:

  • ISO 10993-23: Biological evaluation of medical devicesPart 23: Tests for residual substances

  • ASTM F748: Standard Practice for Selecting, Testing, and Evaluating Medical and Surgical Materials and Devices

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

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are all involved in developing standards related to BER testing.

    How Standards Evolve and Get Updated

    Standards evolve and get updated through a continuous process of review, revision, and approval. This ensures that standards remain relevant and effective in addressing emerging issues and technologies.

    Specific Standard Numbers and Their Scope

    Some key standard numbers and their scope include:

  • ISO 10993-23: Tests for residual substances

  • ASTM F748: Selecting, testing, and evaluating medical and surgical materials and devices

  • EN ISO 10993-5: In vitro cytotoxicity tests

    • Compliance Requirements for Different Industries

    Compliance requirements for different industries may vary depending on the specific regulations and standards applicable to each industry. For example:

  • Medical device manufacturers must comply with EU MDR and FDA regulations in the US.

  • Pharmaceutical companies must comply with ICH Q3A guidelines.

    • BER testing is a critical component of ensuring the safety and efficacy of medical devices and materials. This section will explain why this specific test is needed and required, as well as the business and technical reasons for conducting BER testing.

    Why is this Test Needed?

    BER testing is essential to ensure that residual substances present in medical devices or materials do not pose a risk to patients or users. Without adequate testing, manufacturers may be liable for any harm caused by their products.

    Business and Technical Reasons

    The business and technical reasons for conducting BER testing include:

  • Ensuring compliance with regulatory requirements

  • Demonstrating product safety and efficacy

  • Protecting brand reputation and patient trust

  • Reducing liability risks

  • Improving product quality and performance

    • Consequences of Not Performing this Test

    Failure to conduct BER testing can result in severe consequences, including:

  • Non-compliance with regulations

  • Product recalls or market withdrawals

  • Financial penalties and fines

  • Damage to brand reputation and patient trust

  • Increased liability risks

    • Industries and Sectors that Require this Testing

    BER testing is required for various industries and sectors, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Cosmetic and personal care product manufacturers

    • Risk Factors and Safety Implications

    BER testing helps mitigate risk factors and safety implications associated with residual substances in medical devices or materials.

    Quality Assurance and Control Aspects

    BER testing involves rigorous quality assurance and control measures to ensure accurate and reliable results. These measures include:

  • Strict testing protocols

  • Calibrated equipment and instruments

  • Trained and certified personnel

  • Regular quality control checks

    • Contribution to Product Safety and Reliability

    BER testing contributes significantly to product safety and reliability by identifying potential risks associated with residual substances.

    Competitive Advantages of Having this Testing Performed

    Having BER testing performed can provide significant competitive advantages, including:

  • Enhanced brand reputation and patient trust

  • Improved product quality and performance

  • Reduced liability risks

  • Increased market access and trade facilitation

    • Cost-Benefit Analysis

    The cost-benefit analysis of performing BER testing is essential to ensure that the benefits outweigh the costs.

    Test Methodology and Procedures

    BER testing involves a range of test methodologies and procedures, including:

  • Extraction and identification of residual substances

  • Toxicity tests using in vitro or in vivo models

  • Chemical characterization and quantification of residual substances

    • Test Reporting and Documentation

    BER testing results must be reported and documented accurately to ensure transparency and compliance with regulations.

    Iso 10993-23 Biological Evaluation of Medical DevicesPart 23: Tests for Residual Substances

    This standard outlines the requirements for evaluating the biological safety of medical devices and materials, including residual substances that may be present in the device or material.

    Scope and Application

    The scope and application of this standard are as follows:

  • Applies to medical devices and materials

  • Evaluates residual substances using in vitro and in vivo tests

  • Provides guidance on test selection and interpretation

    • BER Testing Process at Eurolab

    Eurolabs BER testing process involves the following steps:

    1. Sample preparation and extraction

    2. Identification of residual substances using chemical characterization and quantification techniques

    3. Toxicity testing using in vitro or in vivo models

    4. Data analysis and reporting

    Conclusion

    In conclusion, BER testing is a critical component of ensuring product safety and efficacy for medical devices and materials. Eurolabs comprehensive guide to BER testing provides essential information on standard-related requirements, test methodology, and procedures.

    Choosing the Right Partner for Your BER Testing Needs

    When selecting a partner for your BER testing needs, consider the following factors:

  • Expertise in regulatory compliance

  • Extensive experience with medical device testing

  • State-of-the-art facilities and equipment

  • Trained and certified personnel

  • Reputation for accuracy and reliability

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

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