EUROLAB
iso-11607-packaging-for-terminally-sterilized-devices
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 11607-1 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 11607 Packaging for Terminally Sterilized Devices Laboratory Testing Service

Provided by Eurolab: Expertise in Ensuring Product Safety and Compliance

ISO 11607 is an international standard that specifies the requirements for packaging systems designed to maintain sterility of terminally sterilized medical devices. The standard is published by the International Organization for Standardization (ISO) and is widely adopted globally.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 11607 testing is governed by various national and international standards, regulations, and directives. These include:

  • ISO 11607-1:2016

  • ISO 11607-2:2016

  • ASTM F2100-08 (Standard Specification for Woven or Knitted Fabric for Surgical Implants)

  • EN 868-3:2009 (Sterilization indicators)

  • TSE 1484 (Turkish Standard for Packaging Systems for Medical Devices)

    • International and National Standards

    The international standards that apply to ISO 11607 testing are:

  • ISO 13485 (Medical devices - Quality management systems - Requirements for regulatory purposes)

  • ISO 14971 (Medical devices - Application of risk management to medical devices)

    • National standards that may also be applicable include:

  • FDA regulations in the United States

  • CE marking requirements in Europe

    • Standard Development Organizations and Their Role

    Standard development organizations, such as ISO, play a crucial role in maintaining and updating standards. They involve stakeholders from industry, regulatory bodies, and other relevant parties to ensure that standards remain relevant and effective.

    Standards evolve over time to reflect changes in technology, best practices, and regulatory requirements. New versions of standards are published periodically, incorporating updates and improvements.

    Standard Compliance Requirements for Different Industries

    Compliance with ISO 11607 is a requirement for medical device manufacturers who wish to market their products globally. This standard applies to all types of medical devices, including:

  • Sterilizable devices

  • Devices intended for single-use

  • Reusable devices

  • Devices that require sterilization at the point of use

    • Manufacturers must ensure that their packaging systems meet the requirements outlined in ISO 11607-1 and ISO 11607-2.

    ISO 11607 testing is necessary to ensure that medical devices remain sterile throughout their shelf life. This standard specifies the requirements for packaging systems, including:

  • Materials

  • Construction

  • Testing

  • Validation

    • Business and Technical Reasons for Conducting ISO 11607 Testing

    The business and technical reasons for conducting ISO 11607 testing include:

  • Ensuring product safety

  • Maintaining regulatory compliance

  • Demonstrating quality assurance

  • Enhancing customer confidence

  • Improving market access and trade facilitation

    • Consequences of Not Performing This Test

    Failure to perform ISO 11607 testing can result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Loss of reputation and market share

  • Increased costs due to rework, retesting, or corrective actions

    • The ISO 11607 test involves evaluating the packaging systems ability to maintain sterility throughout its shelf life. The testing environment must be controlled to simulate real-world conditions.

    Testing Equipment and Instruments Used

  • Sterilization equipment (e.g., autoclave, radiation source)

  • Packaging materials (e.g., paper, plastic, foil)

  • Medical devices (e.g., surgical implants, wound dressings)

    • The testing environment must be controlled to simulate real-world conditions. This includes:

  • Temperature

  • Humidity

  • Pressure

    • Sample Preparation Procedures

    Samples of packaging systems and medical devices are prepared according to ISO 11607-2. This involves:

  • Selecting representative samples

  • Preparing test specimens

  • Conducting testing and evaluation

    • The measurement and analysis methods used in ISO 11607 testing include:

  • Visual inspection

  • Microbiological testing (e.g., sterility testing, bioburden testing)

  • Physical testing (e.g., leak testing, burst pressure testing)

    • Quality Control Measures During Testing

    Quality control measures are implemented throughout the testing process to ensure accuracy and reliability.

    ISO 11607 test results must be documented in a clear and concise manner. The report should include:

  • Test specifications

  • Testing conditions

  • Results

  • Interpretation of results

  • Conclusion and recommendations

    • Certification and Accreditation Aspects

    Certification and accreditation are essential for ensuring the competence and reliability of testing laboratories.

    ISO 11607 testing is necessary to ensure that medical devices remain sterile throughout their shelf life. This standard provides a framework for evaluating packaging systems and ensuring compliance with regulatory requirements.

    Benefits of ISO 11607 Testing

    The benefits of ISO 11607 testing include:

  • Ensuring product safety

  • Maintaining regulatory compliance

  • Demonstrating quality assurance

  • Enhancing customer confidence

  • Improving market access and trade facilitation

    • Conclusion

    ISO 11607 is an essential standard for ensuring the sterility of medical devices throughout their shelf life. By understanding the requirements outlined in this standard, manufacturers can ensure compliance with regulatory requirements and maintain product safety.

    Glossary of Terms

  • Sterilizable device: A medical device that requires sterilization before use.

  • Single-use device: A medical device intended for one-time use only.

  • Reusable device: A medical device designed for multiple uses.

  • Point-of-use sterilization: Sterilization at the point of use, typically by the healthcare provider.

    • References

  • ISO 11607-1:2016

  • ISO 11607-2:2016

  • ASTM F2100-08 (Standard Specification for Woven or Knitted Fabric for Surgical Implants)

  • EN 868-3:2009 (Sterilization indicators)

  • TSE 1484 (Turkish Standard for Packaging Systems for Medical Devices)

    • About Eurolab

    Eurolab is a leading provider of testing and certification services. Our team of experts has extensive knowledge and experience in evaluating packaging systems and ensuring compliance with regulatory requirements.

    Get in Touch

    Contact us today to learn more about our ISO 11607 testing services or to schedule an appointment for your medical device manufacturer.

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

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