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iso-14160-biocompatibility-for-transfusion-equipment
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 10993-23 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 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 14160 Biocompatibility for Transfusion Equipment Laboratory Testing Service: A Comprehensive Guide

ISO 14160 is an international standard that specifies the requirements for biocompatibility testing of transfusion equipment. The standard is developed by the International Organization for Standardization (ISO) and published in collaboration with the American Society for Testing and Materials (ASTM). The standard is designed to ensure the safety and efficacy of transfusion equipment by assessing its potential biological risks.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 14160 biocompatibility testing is complex and multifaceted. In the European Union, for example, the Medical Device Regulation (MDR) requires that medical devices, including transfusion equipment, undergo biocompatibility testing in accordance with ISO 14160. Similarly, in the United States, the Food and Drug Administration (FDA) requires that medical devices, including transfusion equipment, undergo biocompatibility testing in accordance with ASTM F748.

International and National Standards

The following international and national standards apply to ISO 14160 biocompatibility testing:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

  • ISO 10993-5:2009AMD1:2020 (consolidated version) Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

  • ASTM F748: Standard Practice for Selecting, Testing, and Specifying Biological Test Animals and Materials

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and other standard development organizations play a crucial role in developing and maintaining standards related to biocompatibility testing. These organizations work together to ensure that standards are developed, published, and updated in a transparent and collaborative manner.

    Standard Evolution and Update

    Standards evolve over time as new technologies, materials, and testing methods emerge. ISO 14160 is no exception, with updates and revisions made periodically to reflect changing regulatory requirements, advances in technology, and emerging scientific evidence.

    Specific Standard Numbers and Scope

    The following standard numbers and scope apply to ISO 14160 biocompatibility testing:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

    • Covers the evaluation and testing of medical devices for biological safety, including transfusion equipment.

  • ISO 10993-5:2009AMD1:2020 (consolidated version) Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

    • Specifies tests for in vitro cytotoxicity, which is a critical aspect of biocompatibility testing.

    Standard Compliance Requirements

    Compliance with ISO 14160 requires that transfusion equipment manufacturers and suppliers:

  • Conduct biocompatibility testing according to ISO 10993-1:2018 and ISO 10993-5:2009AMD1:2020

  • Document the testing and evaluation of their products in accordance with regulatory requirements

  • Maintain records of testing, evaluation, and compliance with standards

    • Why is this test needed and required?

    Transfusion equipment requires biocompatibility testing to ensure that it does not cause adverse biological reactions or effects. The ISO 14160 standard specifies the requirements for biocompatibility testing of transfusion equipment, including the evaluation of potential cytotoxicity, genotoxicity, and irritation.

    Business and Technical Reasons for Conducting ISO 14160 Biocompatibility Testing

    Conducting ISO 14160 biocompatibility testing is essential for several business and technical reasons:

  • Compliance with regulatory requirements

  • Ensuring product safety and efficacy

  • Avoiding costly recalls or product withdrawals

  • Protecting brand reputation and customer trust

  • Maintaining competitiveness in the market

    • Consequences of Not Performing this Test

    Failure to conduct ISO 14160 biocompatibility testing can have serious consequences, including:

  • Non-compliance with regulatory requirements

  • Product safety and efficacy issues

  • Costly recalls or product withdrawals

  • Damage to brand reputation and customer trust

  • Loss of competitiveness in the market

    • Industries and Sectors that Require this Testing

    Transfusion equipment manufacturers and suppliers in various industries and sectors require ISO 14160 biocompatibility testing, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Hospitals and healthcare institutions

    • Risk Factors and Safety Implications

    Biocompatibility testing is essential to identify potential risk factors and safety implications associated with transfusion equipment. The main risks and safety implications include:

  • Adverse biological reactions or effects

  • Genotoxicity, mutagenicity, or carcinogenicity

  • Irritation, corrosion, or other forms of damage

    • Quality Assurance and Quality Control Aspects

    Conducting ISO 14160 biocompatibility testing is an essential aspect of quality assurance and quality control in the development, production, and supply of transfusion equipment. The main aspects include:

  • Compliance with regulatory requirements

  • Documented testing and evaluation procedures

  • Maintenance of records and data

    • Laboratory Testing and Evaluation

    Laboratory testing and evaluation are critical components of ISO 14160 biocompatibility testing. The following tests and evaluations may be conducted:

  • Cytotoxicity testing (ISO 10993-5:2009AMD1:2020)

  • Genotoxicity testing

  • Irritation testing

  • Corrosion testing

    • Conclusion

    In conclusion, ISO 14160 biocompatibility testing is a critical aspect of ensuring the safety and efficacy of transfusion equipment. Manufacturers and suppliers must comply with regulatory requirements, conduct biocompatibility testing according to standard procedures, and maintain records of testing and evaluation.

    ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

  • Covers the evaluation and testing of medical devices for biological safety, including transfusion equipment.

  • Specifies tests for in vitro cytotoxicity, genotoxicity, irritation, corrosion, and other forms of damage.

    • Laboratory testing and evaluation are critical components of ISO 14160 biocompatibility testing. The following tests and evaluations may be conducted:

  • Cytotoxicity testing (ISO 10993-5:2009AMD1:2020)

  • Genotoxicity testing

  • Irritation testing

  • Corrosion testing

    • Conclusion

    In conclusion, ISO 14160 biocompatibility testing is a critical aspect of ensuring the safety and efficacy of transfusion equipment. Manufacturers and suppliers must comply with regulatory requirements, conduct biocompatibility testing according to standard procedures, and maintain records of testing and evaluation.

    ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

  • Covers the evaluation and testing of medical devices for biological safety, including transfusion equipment.

  • Specifies tests for in vitro cytotoxicity, genotoxicity, irritation, corrosion, and other forms of damage.

    • Laboratory testing and evaluation are critical components of ISO 14160 biocompatibility testing. The following tests and evaluations may be conducted:

  • Cytotoxicity testing (ISO 10993-5:2009AMD1:2020)

  • Genotoxicity testing

  • Irritation testing

  • Corrosion testing

    • Conclusion

    In conclusion, ISO 14160 biocompatibility testing is a critical aspect of ensuring the safety and efficacy of transfusion equipment. Manufacturers and suppliers must comply with regulatory requirements, conduct biocompatibility testing according to standard procedures, and maintain records of testing and evaluation.

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