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en-868-1-packaging-materials-for-terminally-sterilized-medical-devices
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

Comprehensive Guide to EN 868-1 Packaging Materials for Terminally Sterilized Medical Devices Laboratory Testing Service

EN 868-1 is a European standard that specifies the requirements for packaging materials for terminally sterilized medical devices. This standard is part of the EN 868 series, which covers various aspects of packaging materials for medical devices. The standard is developed and maintained by CEN (European Committee for Standardization) in collaboration with ISO (International Organization for Standardization).

Legal and Regulatory Framework

The legal and regulatory framework surrounding EN 868-1 testing is governed by various international and national standards, regulations, and directives. Some of the key standards and regulations include:

  • EU Medical Device Regulation (MDR) 2017/745

  • ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems, and packaging systems

  • ASTM F1929-15 Standard Practice for Testing Medical Devices Using a Vibration Test Apparatus

  • EN 13068:2015 Medical gloves Part 3: Performance requirements

    • International and National Standards

    The following standards apply to this specific laboratory test:

  • ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems, and packaging systems

  • EN 13068:2015 Medical gloves Part 3: Performance requirements

    • Standard Development Organizations

    The standard development organizations involved in the creation and maintenance of EN 868-1 include:

  • CEN (European Committee for Standardization)

  • ISO (International Organization for Standardization)

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulations, and best practices. New versions of standards are developed through a collaborative process involving experts from various industries and countries.

    Standard Numbers and Scope

    The following standard numbers and their scope apply to EN 868-1:

  • EN 868-1: Packaging materials for terminally sterilized medical devices Part 1: Requirements for packaging

  • EN 13068:2015 Medical gloves Part 3: Performance requirements

    • Industry-Specific Compliance Requirements

    Different industries have specific compliance requirements for EN 868-1 testing. For example:

  • Medical device manufacturers must comply with EU MDR and ISO 11607-1.

  • Pharmaceutical companies may need to comply with FDA regulations in the United States.

    • Standard-Related Information Conclusion

    EN 868-1 is an essential standard for packaging materials used in terminally sterilized medical devices. Understanding the legal, regulatory, and technical aspects of this standard is crucial for industries involved in medical device manufacturing.

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    Why is EN 868-1 testing necessary?

  • Business Reasons: Medical device manufacturers must comply with EU MDR and ISO 11607-1 to maintain market access.

  • Technical Reasons: Packaging materials used for terminally sterilized medical devices require specific properties, such as barrier resistance and moisture vapor transmission rate.

    • Consequences of Not Performing EN 868-1 Testing

    Failure to perform EN 868-1 testing can lead to:

  • Non-compliance with EU MDR and ISO 11607-1

  • Reduced product safety and reliability

  • Decreased customer confidence

    • Industries and Sectors Requiring EN 868-1 Testing

    EN 868-1 testing is required in various industries, including:

  • Medical device manufacturing

  • Pharmaceutical companies

  • Hospitals and healthcare institutions

    • Risk Factors and Safety Implications

    EN 868-1 testing helps mitigate risks associated with packaging materials used for terminally sterilized medical devices. These risks include:

  • Moisture vapor transmission rate (MVTR)

  • Barrier resistance

  • Sterilization validation

  • Packaging system integrity

    • Quality Assurance and Quality Control Aspects

    EN 868-1 testing is an essential part of quality assurance and quality control processes. It ensures that packaging materials meet specific requirements, thereby maintaining product safety and reliability.

    Competitive Advantages of EN 868-1 Testing

    Performing EN 868-1 testing provides competitive advantages, including:

  • Compliance with EU MDR and ISO 11607-1

  • Improved product safety and reliability

  • Increased customer confidence

    • Cost-Benefit Analysis of EN 868-1 Testing

    The cost-benefit analysis of EN 868-1 testing is favorable due to the following reasons:

  • Reduced risk of non-compliance with regulations

  • Improved product safety and reliability

  • Increased customer confidence and market access

    • ---

    Step-by-Step Explanation of EN 868-1 Testing

    EN 868-1 testing involves the following steps:

    1. Sample Preparation: The packaging material is cut into samples according to the standard.

    2. Moisture Vapor Transmission Rate (MVTR) Test: Samples are placed in a controlled environment, and MVTR is measured.

    3. Barrier Resistance Test: Samples are subjected to a barrier resistance test using a specified method.

    4. Sterilization Validation: Samples are sterilized using a validated process, and their integrity is evaluated.

    EN 868-1 Testing Methodology

    The EN 868-1 testing methodology involves the following:

  • Sample Preparation: Samples are prepared according to the standard.

  • Instrumentation: Specific instrumentation, such as MVTR testers and barrier resistance testers, is used for testing.

  • Test Conditions: Test conditions, including temperature, humidity, and time, are specified in the standard.

    • EN 868-1 Testing Limitations

    The following limitations apply to EN 868-1 testing:

  • Sampling Errors: Sampling errors can occur due to incorrect sampling methods or equipment malfunctions.

  • Instrumentation Errors: Instrumentation errors can result from inaccurate calibration or faulty equipment.

    • ---

    Test Conditions and Methodology Conclusion

    EN 868-1 testing is a crucial process that ensures packaging materials meet specific requirements. Understanding the test conditions and methodology involved in EN 868-1 testing is essential for industries involved in medical device manufacturing.

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    This comprehensive guide to EN 868-1 laboratory testing service has provided an overview of the standard, its importance, and the benefits of compliance. The technical details of the testing process have been discussed, including sample preparation, MVTR test, barrier resistance test, and sterilization validation. By understanding the requirements and limitations of EN 868-1 testing, industries involved in medical device manufacturing can ensure that their packaging materials meet specific standards, thereby maintaining product safety and reliability.

    Additional Resources

    For further information on EN 868-1 laboratory testing service, please refer to the following resources:

  • CEN Website: www.cen.eu(http://www.cen.eu)

  • ISO Website: www.iso.org(http://www.iso.org)

  • EU MDR Regulation: ec.europa.eu/health/documents/eudralex-volume-iv/en/index.htm(http://ec.europa.eu/health/documents/eudralex-volume-iv/en/index.htm)

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