EUROLAB
iso-18113-medical-device-labeling
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 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 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 18113 Medical Device Labeling Laboratory Testing Service Provided by Eurolab

ISO 18113 is a widely recognized standard that governs the labeling of medical devices. The standard was developed by the International Organization for Standardization (ISO) and provides guidelines for labeling, packaging, and instructions for use.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 18113 Medical Device Labeling testing is governed by various international and national standards. These standards include:

  • EN ISO 15223-1:2016: This standard specifies the requirements for information to be included on medical devices.

  • EN ISO 15223-2:2019: This standard provides additional guidelines for labeling, packaging, and instructions for use.

  • Medical Device Regulation (MDR) EU 2017/745: This regulation sets out the requirements for medical device manufacturers in the European Union.

    • Standard Development Organizations

    The development of standards is a collaborative effort between various organizations, including:

  • International Organization for Standardization (ISO): ISO develops and publishes international standards.

  • European Committee for Standardization (CEN): CEN develops and publishes European standards.

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. This evolution is driven by a variety of factors, including:

  • Advances in technology: New technologies require updates to existing standards.

  • Changes in regulations: Regulatory requirements drive the need for standard updates.

  • Industry feedback: Industry stakeholders provide input on how standards can be improved.

    • Standard Numbers and Scope

    The following are some relevant standard numbers and their scope:

    Standard Number Title

    --- ---

    ISO 15223-1:2016 Medical devices - Information to be supplied by the manufacturer (ISO 15223-1:2000) with corrigendum ISO 15223-1:2000/Amd 1:2015, including amendments ISO 15223-1:2000/Cor 1:2007 and ISO 15223-1:2000/Cor 2:2008.

    ISO 15223-2:2019 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (ISO 15223-2:2019).

    Compliance Requirements

    Compliance with standards is a critical aspect of medical device labeling. The following industries require compliance with ISO 18113:

  • Medical Device Manufacturers: Medical device manufacturers must comply with ISO 18113 for their products.

  • Distributors and Suppliers: Distributors and suppliers must also comply with ISO 18113.

    • ISO 18113 Medical Device Labeling testing is a critical aspect of ensuring product safety, reliability, and compliance. The following are some reasons why this test is necessary:

    Business and Technical Reasons

    The business and technical reasons for conducting ISO 18113 Medical Device Labeling testing include:

  • Ensuring Product Safety: Proper labeling ensures that users understand the safe use of medical devices.

  • Compliance with Regulations: Compliance with regulations drives the need for standard updates.

    • Consequences of Not Performing This Test

    The consequences of not performing this test include:

  • Non-Compliance with Regulations: Non-compliance with regulations can result in fines and penalties.

  • Product Liability: Failure to ensure product safety can lead to product liability claims.

    • Industries and Sectors

    The following industries and sectors require ISO 18113 Medical Device Labeling testing:

  • Medical Device Manufacturers: Medical device manufacturers must comply with ISO 18113 for their products.

  • Distributors and Suppliers: Distributors and suppliers must also comply with ISO 18113.

    • Risk Factors and Safety Implications

    The risk factors and safety implications of non-compliance with ISO 18113 include:

  • Product Liability: Failure to ensure product safety can lead to product liability claims.

  • Non-Compliance with Regulations: Non-compliance with regulations can result in fines and penalties.

    • Quality Assurance and Quality Control Aspects

    The quality assurance and quality control aspects of ISO 18113 Medical Device Labeling testing include:

  • Ensuring Product Safety: Proper labeling ensures that users understand the safe use of medical devices.

  • Compliance with Regulations: Compliance with regulations drives the need for standard updates.

    • Competitive Advantages

    The competitive advantages of having ISO 18113 Medical Device Labeling testing performed include:

  • Increased Customer Confidence: Compliance with standards increases customer confidence in products.

  • Improved Market Positioning: Compliance with standards can improve market positioning.

    • ISO 18113 Medical Device Labeling testing is a critical aspect of ensuring product safety, reliability, and compliance. The following are some test conditions and methodology:

    Test Conditions

    The following are the test conditions for ISO 18113 Medical Device Labeling testing:

  • Temperature: The temperature range is between -20C and 40C.

  • Humidity: The humidity level is between 30 and 70.

    • Methodology

    The following is the methodology for ISO 18113 Medical Device Labeling testing:

    1. Label Design: Labels must be designed in accordance with the standard.

    2. Label Printing: Labels must be printed using a suitable printing method.

    3. Label Application: Labels must be applied to medical devices.

    Equipment and Tools

    The following equipment and tools are required for ISO 18113 Medical Device Labeling testing:

  • Temperature Chamber: A temperature chamber is required to simulate the test conditions.

  • Humidity Chamber: A humidity chamber is required to simulate the test conditions.

  • Label Printer: A label printer is required to print labels.

    • Test Procedures

    The following are the test procedures for ISO 18113 Medical Device Labeling testing:

    1. Pre-Test Preparation: Pre-test preparation includes preparing the equipment and tools, and ensuring that the test conditions are suitable.

    2. Label Testing: Labels must be tested in accordance with the standard.

    3. Device Testing: Devices must be tested in accordance with the standard.

    Test Reports

    The following information must be included in the test report:

  • Test Conditions: The test conditions, including temperature and humidity levels.

  • Label Design: The label design used for testing.

  • Results: The results of the testing, including any observations or issues encountered.

    • Conclusion

    ISO 18113 Medical Device Labeling testing is a critical aspect of ensuring product safety, reliability, and compliance. Compliance with standards is a critical aspect of medical device labeling. This includes:

  • Label Design: Labels must be designed in accordance with the standard.

  • Label Printing: Labels must be printed using a suitable printing method.

  • Label Application: Labels must be applied to medical devices.

    • Failure to comply with ISO 18113 can result in fines and penalties, as well as product liability claims. Therefore, it is essential to ensure compliance with standards.

    References

    The following references were used for this document:

  • ISO 15223-1:2016: Medical devices - Information to be supplied by the manufacturer (ISO 15223-1:2000) with corrigendum ISO 15223-1:2000/Amd 1:2015, including amendments ISO 15223-1:2000/Cor 1:2007 and ISO 15223-1:2000/Cor 2:2008.

  • ISO 15223-2:2019: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (ISO 15223-2:2019).

  • Medical Device Regulation (MDR) EU 2017/745: This regulation sets out the requirements for medical device manufacturers in the European Union.

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