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en-iso-10993-1-biological-evaluation-part-1
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 10993-10 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 10993-23 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

EN ISO 10993-1 Biological Evaluation Part 1 Laboratory Testing Service Provided by Eurolab

The EN ISO 10993-1 Biological Evaluation Part 1 testing service is governed by a set of international and national standards that ensure the safety and efficacy of medical devices. The relevant standards include:

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

  • ASTM F748-18: Standard Practice for Selecting Glass, Ceramic, and Stone Materials for Medical Applications

  • EN ISO 14971:2012: Medical devices Application of risk management to medical devices

    • These standards provide the framework for conducting biological evaluations on medical devices, ensuring their safety and efficacy. The International Organization for Standardization (ISO) develops and publishes these standards, which are adopted by countries worldwide.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding EN ISO 10993-1 Biological Evaluation Part 1 testing is governed by various regulations, including:

  • EU Medical Device Regulation (MDR): EU regulation on medical devices that requires manufacturers to conduct biological evaluations

  • US FDA Guidance on CDRH: US Food and Drug Administration guidance on the Center for Devices and Radiological Healths requirements for biological evaluations

  • ISO 13485:2016: Medical devices Quality management systems Requirements for regulatory purposes

    • These regulations require medical device manufacturers to conduct biological evaluations as part of their risk management process.

    Standard Development Organizations

    The standard development organizations responsible for developing and maintaining the relevant standards include:

  • International Organization for Standardization (ISO): Develops and publishes international standards, including ISO 10993-1

  • American Society for Testing and Materials (ASTM): Develops and publishes ASTM F748-18

  • European Committee for Standardization (CEN): Develops and publishes EN ISO 14971

    • These organizations ensure that the standards remain up-to-date and relevant to industry needs.

    Standard Evolution and Updates

    Standards evolve over time as new technologies emerge, and scientific understanding improves. The standard development process involves:

  • Review and revision: Standards are reviewed periodically to ensure they remain relevant and effective

  • Public consultation: Stakeholders and experts provide input on proposed changes to the standard

  • Publication: Revised standards are published, replacing outdated versions

    • Eurolab stays up-to-date with these developments and ensures its testing services comply with the latest standards.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope include:

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

    • Scope: Covers the evaluation and testing of medical devices to ensure their safety and efficacy

  • ASTM F748-18: Standard Practice for Selecting Glass, Ceramic, and Stone Materials for Medical Applications

    • Scope: Provides guidance on selecting materials for medical applications

    Eurolabs EN ISO 10993-1 Biological Evaluation Part 1 testing service ensures compliance with these standards.

    Industry-Specific Compliance Requirements

    Different industries require varying levels of biological evaluation. Some examples include:

  • Medical devices: Manufacturers must conduct biological evaluations to ensure their products meet regulatory requirements

  • Pharmaceuticals: Companies must conduct biological evaluations to assess the safety and efficacy of new medications

    • Eurolabs testing services cater to these industry-specific needs.

    The EN ISO 10993-1 Biological Evaluation Part 1 testing service is essential for ensuring medical device safety and efficacy. The business and technical reasons for conducting this test include:

  • Risk assessment: Manufacturers must assess the risks associated with their products to ensure they comply with regulatory requirements

  • Regulatory compliance: Conducting biological evaluations demonstrates compliance with regulations, such as EU MDR and US FDA Guidance on CDRH

    • Consequences of not performing this test can be severe:

  • Product recalls: Non-compliant devices may be recalled from the market, resulting in significant financial losses

  • Reputational damage: Companies that fail to comply with regulations risk damaging their reputation and losing customer trust

    • The industries and sectors requiring EN ISO 10993-1 Biological Evaluation Part 1 testing include:

  • Medical devices: Manufacturers of medical devices must conduct biological evaluations as part of their risk management process

  • Pharmaceuticals: Companies developing new medications require biological evaluations to assess safety and efficacy

    • Risk factors and safety implications associated with non-compliance are significant:

  • Patient harm: Non-compliant products can cause harm to patients, leading to severe consequences for manufacturers and healthcare providers

  • Financial losses: Regulatory non-compliance can result in costly fines, product recalls, and damage to a companys reputation

    • Eurolabs testing services help mitigate these risks by ensuring medical devices meet regulatory requirements.

    This section has provided an overview of the standard-related information governing EN ISO 10993-1 Biological Evaluation Part 1 testing. The relevant standards, legal and regulatory framework, standard development organizations, standard evolution and updates, standard numbers and scope, and industry-specific compliance requirements have been discussed.

    This section has highlighted the business and technical reasons for conducting EN ISO 10993-1 Biological Evaluation Part 1 testing. The consequences of non-compliance, industries requiring this testing, risk factors, and safety implications associated with non-compliance have been discussed.

    Standard Testing Procedures

    The following standard testing procedures are relevant to EN ISO 10993-1 Biological Evaluation Part 1:

  • Material characterization: Materials used in medical devices must be characterized to ensure they meet regulatory requirements

  • In vitro tests: In vitro tests, such as cytotoxicity and genotoxicity assays, are conducted to assess the biological response of materials

  • In vivo tests: In vivo tests, such as implantation studies, are conducted to assess the biological response of devices

    • Eurolabs testing services include these standard testing procedures.

    Test Methods

    The following test methods are relevant to EN ISO 10993-1 Biological Evaluation Part 1:

  • Cytotoxicity assay: Assesses the cytotoxic effects of materials on cells

  • Genotoxicity assay: Assesses the genotoxic effects of materials on DNA

  • Implantation study: Assesses the biological response of devices in vivo

    • Eurolabs testing services employ these test methods.

    Conclusion

    EN ISO 10993-1 Biological Evaluation Part 1 laboratory testing is an essential service provided by Eurolab to ensure medical device safety and efficacy. This section has highlighted the standard-related information, standard requirements, and needs associated with this testing service.

    Eurolabs expertise in biological evaluation ensures that its clients products meet regulatory requirements, mitigating risks and ensuring patient safety.

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