EUROLAB
iso-17665-1-moist-heat-sterilization-of-healthcare-products
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 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 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 17665-2 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 ISO 17665-1 Moist Heat Sterilization of Healthcare Products Laboratory Testing Service

Introduction

In the healthcare industry, ensuring the sterility and safety of medical devices and products is paramount. One of the most widely used methods for achieving sterilization is through moist heat (steam) sterilization. The International Organization for Standardization (ISO) has established a standard for this process, known as ISO 17665-1 Moist Heat Sterilization of Healthcare Products. In this article, we will delve into the world of ISO 17665-1 testing, covering its significance, requirements, methodology, and benefits.

Standard-Related Information

Overview of Relevant Standards

  • ISO 17665-1: Specifies the requirements for moist heat sterilization processes in healthcare establishments.

  • ASTM F2101: Describes the requirements for steam sterilizers used in medical facilities.

  • EN ISO 17665-1: Provides guidelines for the selection and validation of moist heat sterilization methods.

  • TSE (Turkish Standards Institution) 1706: Specifies the requirements for steam sterilizers used in healthcare establishments.

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 17665-1 testing is governed by various international and national standards. These include:

  • ISO/TC 210: The technical committee responsible for developing standards related to medical devices.

  • ASTM F2 Committee on Sterilization: Focuses on the development of standards for sterilization processes.

  • EN ISO Technical Committee 150 (TC 150): Develops and maintains standards for healthcare products, including those related to sterilization.

    • Standard Development Organizations

    Standard development organizations play a crucial role in establishing and maintaining standards. These include:

  • International Organization for Standardization (ISO): A non-profit organization that develops and publishes international standards.

  • American Society for Testing and Materials (ASTM): Develops and publishes technical specifications, guidelines, and standards for various industries, including healthcare.

  • European Committee for Standardization (CEN): Develops and maintains European standards.

    • Evolution of Standards

    Standards evolve over time to address new requirements and technologies. This process involves:

    1. Revision: Updating existing standards to reflect changes in technology or regulatory requirements.

    2. New standard creation: Developing new standards for emerging technologies or processes.

    3. Withdrawal: Retiring outdated standards.

    Standard Compliance Requirements

    Compliance with ISO 17665-1 is mandatory for healthcare establishments and medical device manufacturers. The consequences of non-compliance can include:

  • Fines and penalties

  • Loss of reputation and market share

  • Non-accreditation or certification

    • Industry-Specific Examples and Case Studies

    The following examples illustrate the importance of ISO 17665-1 testing in various industries:

  • Medical device manufacturers: Ensure their products meet sterilization requirements to avoid recalls and maintain customer trust.

  • Healthcare establishments: Verify that equipment and materials comply with ISO 17665-1 standards to prevent contamination and ensure patient safety.

    • Standard Requirements and Needs

    Business and Technical Reasons for Testing

    Conducting ISO 17665-1 testing is essential due to:

  • Ensuring product sterility: Prevents the spread of infections and ensures patient safety.

  • Maintaining regulatory compliance: Avoids fines, penalties, and reputational damage.

  • Improving product reliability: Reduces the risk of equipment failure and minimizes downtime.

    • Consequences of Not Performing This Test

    Failure to perform ISO 17665-1 testing can result in:

  • Product recalls

  • Loss of customer trust

  • Reputational damage

    • Risk Factors and Safety Implications

    The following risks are associated with non-compliance:

  • Infection control issues: Contaminated equipment or materials can lead to patient harm.

  • Equipment failure: Non-sterilized equipment can malfunction, causing downtime and increased costs.

    • Test Conditions and Methodology

    Testing Equipment and Instruments Used

    The following instruments are used for ISO 17665-1 testing:

  • Steam sterilizers

  • Temperature monitoring devices

  • Humidity control systems

    • Sample Preparation Procedures

    Samples must be prepared according to specific guidelines, including:

  • Material selection: Choose materials suitable for steam sterilization.

  • Sample size determination: Ensure adequate sample sizes for testing.

    • Testing Parameters and Conditions

    The following parameters are crucial during ISO 17665-1 testing:

  • Temperature: Maintain a consistent temperature within the specified range.

  • Humidity: Control humidity levels to prevent moisture accumulation.

  • Pressure: Ensure proper pressure settings to maintain sterilization efficacy.

    • Test Reporting and Documentation

    Importance of Accurate Reporting

    Accurate reporting is critical for ensuring compliance with ISO 17665-1 standards. This includes:

  • Record-keeping: Maintain detailed records of testing procedures, results, and calibration.

  • Documentation: Provide clear documentation of testing protocols, equipment maintenance, and validation.

    • Conclusion

    In conclusion, ISO 17665-1 testing is a crucial process for ensuring the sterility and safety of medical devices and products. Compliance with this standard is mandatory for healthcare establishments and manufacturers. By understanding the importance of accurate reporting and maintaining detailed records, organizations can ensure patient safety and maintain regulatory compliance.

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers