EUROLAB
iso-15883-1-washer-disinfectors-for-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 868-1 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 15883-2 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

ISO 15883-1 Washer-Disinfectors for Medical Devices Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The ISO 15883-1 standard is a widely accepted international standard that governs the testing of washer-disinfectors for medical devices. This standard provides guidelines and requirements for the design, development, and testing of washer-disinfectors to ensure their safety and effectiveness in disinfecting medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 15883-1 testing is complex and varies by country and region. In general, medical device manufacturers must comply with regulations such as the EUs Medical Device Regulation (MDR), the US FDAs Quality System Regulation (QSR), and other national and international standards.

International and National Standards

The following international and national standards are relevant to ISO 15883-1 testing:

  • ISO 15883-1:2006 Washer-disinfectors - Part 1: Requirements for washer-disinfectors employing a chemical disinfection process

  • EN 13037:2015 Medical suture materials and sutures. Identification and labelling of medical devices

  • TSE (Turkish Standards Institution) standards, such as TS EN ISO 15883-1:2006 Washer-disinfectors - Part 1: Requirements for washer-disinfectors employing a chemical disinfection process

    • Standard Development Organizations

    The standard development organizations involved in the development and maintenance of ISO 15883-1 include:

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution and Updates

    Standards evolve over time to reflect advances in technology, changing regulatory requirements, and new scientific knowledge. The latest version of ISO 15883-1 was published in 2006, but it is currently under review for revision.

    Standard Compliance Requirements

    Compliance with ISO 15883-1 requires manufacturers to ensure that their washer-disinfectors meet the standards requirements for design, development, testing, and documentation. This includes:

  • Designing and developing washer-disinfectors that meet the standards requirements

  • Conducting tests to demonstrate compliance with the standard

  • Maintaining records of testing and quality control procedures

    • Industries and Sectors

    The following industries and sectors require ISO 15883-1 testing:

  • Medical device manufacturers

  • Healthcare facilities

  • Pharmaceutical companies

  • Biotechnology firms

    • Risk Factors and Safety Implications

    Non-compliance with ISO 15883-1 can lead to risks such as:

  • Inadequate disinfection of medical devices, leading to patient harm or infection

  • Non-conformance with regulatory requirements, resulting in fines or penalties

  • Damage to the manufacturers reputation and brand

    • Quality Assurance and Quality Control

    Compliance with ISO 15883-1 requires a quality management system that includes:

  • Design control procedures

  • Development and testing protocols

  • Documentation and record-keeping procedures

  • Continuous monitoring and improvement of processes

    • Contribution to Product Safety and Reliability

    ISO 15883-1 testing contributes to product safety and reliability by ensuring that washer-disinfectors are designed, developed, and tested to meet rigorous standards. This reduces the risk of adverse events and improves patient outcomes.

    Competitive Advantages and Market Positioning

    Compliance with ISO 15883-1 provides a competitive advantage in the market by:

  • Demonstrating commitment to quality and safety

  • Enhancing reputation and brand image

  • Improving customer confidence and trust

    • Cost-Benefit Analysis

    The cost-benefit analysis of performing ISO 15883-1 testing is favorable, as it can lead to:

  • Cost savings through improved efficiency and reduced waste

  • Reduced risk of adverse events and liability claims

  • Improved market share and revenue growth

    • Test Conditions and Methodology

    The following are the test conditions and methodology for ISO 15883-1 testing:

  • Temperature: 30C 2C

  • Humidity: 55 5

  • Pressure: Atmospheric pressure

  • Sample preparation: Sterile water or a suitable surrogate solution

    • Test Parameters and Conditions

    The following are the test parameters and conditions for ISO 15883-1 testing:

  • Temperature: 60C 2C

  • Time: 15 minutes 1 minute

  • Pressure: 1 bar 0.1 bar

  • Sample preparation: Sterile water or a suitable surrogate solution

    • Measurement and Analysis Methods

    The following are the measurement and analysis methods for ISO 15883-1 testing:

  • Microbiological analysis using standard plate count methods

  • Chemical analysis using high-performance liquid chromatography (HPLC)

  • Physical measurements using calibrated instruments

    • Calibration and Validation Procedures

    The following are the calibration and validation procedures for ISO 15883-1 testing:

  • Calibrate all measuring instruments before use

  • Validate test methods using reference materials or standard solutions

    • Conclusion

    ISO 15883-1 is a widely accepted international standard that governs the testing of washer-disinfectors for medical devices. Compliance with this standard requires manufacturers to ensure that their products meet rigorous requirements for design, development, testing, and documentation. By following the guidelines outlined in this guide, manufacturers can improve product safety and reliability, reduce risk, and enhance market share.

    Recommendations

    The following are recommendations for manufacturers:

  • Ensure compliance with ISO 15883-1 by implementing a quality management system that includes design control procedures, development and testing protocols, documentation and record-keeping procedures, and continuous monitoring and improvement of processes.

  • Conduct regular audits and inspections to ensure ongoing compliance with the standard.

  • Provide training and education to employees on the importance of complying with ISO 15883-1.

    • By following these recommendations, manufacturers can demonstrate their commitment to quality and safety, enhance their reputation and brand image, and improve customer confidence and trust.

    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