EUROLAB
iso-11135-ethylene-oxide-sterilization
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 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

Comprehensive Guide to ISO 11135 Ethylene Oxide Sterilization Laboratory Testing Service

ISO 11135 is an international standard that outlines the requirements for ethylene oxide sterilization of medical devices. This standard provides guidelines for ensuring the safety and effectiveness of ethylene oxide sterilization processes, which are widely used in the medical device industry.

International Standards

The ISO 11135 standard is developed by the International Organization for Standardization (ISO), a non-profit organization that sets global standards for a wide range of industries. Other international standards related to ethylene oxide sterilization include:

  • ASTM F2093: Standard Guide for Selection and Use of Sterilization Processes for Medical Devices That Incorporate Additives

  • EN 455:1995A1:2008: Sterilization indicators - Requirements for performance, testing and calibration

  • TSE (Turkish Standards Institution) ISO 11135:2014

    • National Standards

    In addition to international standards, national standards also play a crucial role in regulating ethylene oxide sterilization. For example:

  • In the European Union, the Medical Device Regulation (MDR) requires medical devices to be sterilized using an ethylene oxide process that meets the requirements of ISO 11135.

  • In the United States, the FDA regulates the use of ethylene oxide for medical device sterilization and requires manufacturers to follow Good Manufacturing Practices (GMPs).

    • Standard Development Organizations

    The development and maintenance of standards like ISO 11135 involve a collaborative effort between industry stakeholders, regulatory bodies, and standard development organizations. Some notable standard development organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards like ISO 11135 are constantly evolving to reflect advances in technology, changes in regulatory requirements, and industry best practices. The standard is reviewed and updated every five years to ensure it remains relevant and effective.

    Scope and Compliance Requirements

    The scope of ISO 11135 covers the requirements for ethylene oxide sterilization processes used for medical devices that are intended to be sterilized using this method. Compliance with the standard is mandatory for manufacturers who wish to market their products in countries where ISO 11135 is adopted.

    Industry-Specific Examples and Case Studies

    The adoption of ISO 11135 has had a significant impact on various industries, including:

  • Medical device manufacturers: Companies like Medtronic and Boston Scientific have implemented ISO 11135-compliant ethylene oxide sterilization processes to ensure the safety and effectiveness of their medical devices.

  • Pharmaceutical companies: Pfizer and Merck Co. have also adopted ISO 11135 for their injectable products.

    • Why is this specific test needed and required?

    Ethylene oxide sterilization is a widely used process in the medical device industry, but it poses several risks if not properly managed. The use of ethylene oxide can lead to chemical residues on medical devices, which may affect their performance or safety.

    Business and Technical Reasons for Conducting ISO 11135 Testing

    Conducting ISO 11135 testing is essential for ensuring the quality and safety of medical devices sterilized using ethylene oxide. This includes:

  • Ensuring compliance with regulatory requirements

  • Reducing the risk of chemical residues on medical devices

  • Improving product reliability and performance

    • Consequences of Not Performing this Test

    Failure to conduct ISO 11135 testing can result in several consequences, including:

  • Non-compliance with regulatory requirements

  • Reduced product quality and safety

  • Increased risk of product recalls or liability claims

    • Risk Factors and Safety Implications

    The use of ethylene oxide sterilization poses several risks, including:

  • Chemical residue formation on medical devices

  • Potential for over-exposure to ethylene oxide

  • Inadequate ventilation during sterilization processes

    • Quality Assurance and Quality Control Aspects

    Conducting ISO 11135 testing is essential for ensuring quality assurance and control aspects of the sterilization process. This includes:

  • Ensuring proper training and qualification of personnel

  • Regular maintenance and calibration of equipment

  • Continuous monitoring of sterilization cycles

    • Step-by-Step Explanation of How the Test is Conducted

    The ISO 11135 test involves several steps, including:

    1. Sample preparation: Medical devices are prepared for testing by cleaning, packaging, and labeling.

    2. Equipment setup: Sterilization equipment is set up according to the manufacturers instructions.

    3. Testing: The sterilization process is performed under controlled conditions, with monitoring of temperature, humidity, and ethylene oxide concentrations.

    4. Sampling: Samples are taken from the sterilized medical devices for analysis.

    Testing Equipment and Instruments Used

    The following equipment and instruments are used during ISO 11135 testing:

  • Sterilization chambers or autoclaves

  • Thermocouples and thermometers

  • Humidity sensors

  • Ethylene oxide detectors

    • Sampling and Analysis

    Samples taken from the sterilized medical devices are analyzed for residues, using techniques such as gas chromatography-mass spectrometry (GC-MS).

    Test Report and Record Keeping

    A comprehensive test report is generated after completion of the ISO 11135 testing. This includes:

  • Test conditions

  • Sampling details

  • Analysis results

    • The test report is kept on file for a minimum period of two years.

    Conclusion

    In conclusion, ISO 11135 is an essential standard for ensuring the quality and safety of medical devices sterilized using ethylene oxide. Conducting this test provides confidence that the sterilization process meets regulatory requirements and industry best practices.

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