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iso-15883-2-washer-disinfectors-for-surgical-instruments
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 15883-3 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 15883-2 Washer-Disinfectors for Surgical Instruments Laboratory Testing Service: A Comprehensive Guide

The ISO 15883-2 standard is a widely accepted international standard that governs the testing of washer-disinfectors for surgical instruments. This standard is published by the International Organization for Standardization (ISO) and is used globally to ensure that washer-disinfectors meet specific requirements for performance, safety, and efficacy.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 15883-2 testing is complex and varies depending on the country. In the European Union, for example, the Medical Devices Regulation (EU) 2017/745 requires that washer-disinfectors be subject to regular testing and validation in accordance with relevant standards.

International and National Standards

The following international and national standards apply to ISO 15883-2 testing:

  • ISO 15883-2:2011(E) Washer-disinfectors - Part 2: Requirements for washer-disinfectors employing a chemical disinfection process

  • EN 13726:2006A1:2013 (EU) Washer-disinfectors - Requirements and tests for washer-disinfectors in the healthcare sector

  • ASTM F1054-15 Standard Specification for Washer/Disinfectors Used in Healthcare Facilities

    • Standard Development Organizations

    The ISO 15883-2 standard was developed by Technical Committee 194, which is responsible for standards related to medical devices. The TC194 committee consists of experts from various countries and industries who work together to develop and maintain the standard.

    Evolution of Standards

    Standards evolve over time as new technologies and methodologies emerge. The ISO 15883-2 standard has undergone several revisions since its initial publication in 1999, with the latest revision published in 2011.

    Standard Compliance Requirements

    Compliance with ISO 15883-2 is mandatory for washer-disinfectors used in healthcare facilities worldwide. Manufacturers must ensure that their products meet all requirements specified in the standard to avoid penalties and fines.

    Industries Requiring Testing

    The following industries require testing of washer-disinfectors according to ISO 15883-2:

  • Healthcare

  • Medical device manufacturing

  • Pharmaceutical industry

  • Food processing

    • Risk Factors and Safety Implications

    Failure to comply with ISO 15883-2 can result in serious safety implications, including:

  • Infection transmission

  • Device malfunction

  • Product failure

  • Economic losses

    • Quality Assurance and Quality Control Aspects

    Regular testing and validation of washer-disinfectors according to ISO 15883-2 ensures that products meet specific requirements for performance, safety, and efficacy.

    Competitive Advantages

    Companies that comply with ISO 15883-2 enjoy several competitive advantages, including:

  • Improved product quality

  • Enhanced customer confidence

  • Increased market share

  • Reduced regulatory risks

    • Cost-Benefit Analysis

    The cost of testing and validation according to ISO 15883-2 is a fraction of the costs associated with non-compliance. Manufacturers who invest in regular testing can avoid costly recalls, penalties, and fines.

    Why This Test Is Needed and Required

    Washer-disinfectors are critical components in healthcare facilities, used to clean and disinfect surgical instruments between procedures. Failure to maintain these devices can lead to infection transmission and other safety risks. Regular testing and validation according to ISO 15883-2 ensures that washer-disinfectors meet specific requirements for performance, safety, and efficacy.

    Business and Technical Reasons

    The business and technical reasons for conducting ISO 15883-2 testing are:

  • Ensure product quality

  • Prevent device malfunction

  • Reduce infection transmission risk

  • Improve customer confidence

    • Consequences of Not Performing This Test

    Failure to comply with ISO 15883-2 can result in serious consequences, including:

  • Product failure

  • Economic losses

  • Regulatory penalties and fines

  • Damage to brand reputation

    • Industries and Sectors Requiring Testing

    The following industries and sectors require testing of washer-disinfectors according to ISO 15883-2:

  • Healthcare

  • Medical device manufacturing

  • Pharmaceutical industry

  • Food processing

    • Risk Factors and Safety Implications

    Failure to comply with ISO 15883-2 can result in serious safety implications, including:

  • Infection transmission

  • Device malfunction

  • Product failure

  • Economic losses

    • Quality Assurance and Quality Control Aspects

    Regular testing and validation of washer-disinfectors according to ISO 15883-2 ensures that products meet specific requirements for performance, safety, and efficacy.

    Competitive Advantages

    Companies that comply with ISO 15883-2 enjoy several competitive advantages, including:

  • Improved product quality

  • Enhanced customer confidence

  • Increased market share

  • Reduced regulatory risks

    • Cost-Benefit Analysis

    The cost of testing and validation according to ISO 15883-2 is a fraction of the costs associated with non-compliance. Manufacturers who invest in regular testing can avoid costly recalls, penalties, and fines.

    ISO 15883-2 Testing Requirements

    The following testing requirements are specified in the ISO 15883-2 standard:

  • Performance tests

  • Safety tests

  • Efficacy tests

  • Endotoxin detection test

    • Performance Tests

    Performance tests include:

  • Water flow rate

  • Water temperature

  • Detergent concentration

  • Rinsing time

    • Safety Tests

    Safety tests include:

  • Electromagnetic compatibility (EMC)

  • Electromagnetic interference (EMI)

    • Efficacy Tests

    Efficacy tests include:

  • Microbiological testing

  • Chemical analysis

    • Endotoxin Detection Test

    The endotoxin detection test is used to detect the presence of bacterial endotoxins in water.

    Testing and Validation Protocol

    The following steps are involved in the testing and validation protocol:

    1. Select a representative sample of washer-disinfectors

    2. Perform performance tests, safety tests, efficacy tests, and endotoxin detection test according to ISO 15883-2 requirements

    3. Analyze results and determine whether products meet specific requirements for performance, safety, and efficacy

    Conclusion

    The ISO 15883-2 standard is a widely accepted international standard that governs the testing of washer-disinfectors for surgical instruments. Regular testing and validation according to this standard ensures that products meet specific requirements for performance, safety, and efficacy.

    Benefits of Testing and Validation

    Regular testing and validation according to ISO 15883-2 offers several benefits, including:

  • Improved product quality

  • Enhanced customer confidence

  • Increased market share

  • Reduced regulatory risks

    • Improved Product Quality

    Testing and validation ensure that products meet specific requirements for performance, safety, and efficacy.

    Enhanced Customer Confidence

    Customers trust manufacturers who invest in regular testing and validation.

    Increased Market Share

    Compliance with ISO 15883-2 can result in increased market share and revenue growth.

    Reduced Regulatory Risks

    Non-compliance with ISO 15883-2 can result in serious regulatory consequences, including penalties and fines.

    Overview of Testing and Validation Process

    The testing and validation process involves the following steps:

    1. Select a representative sample of washer-disinfectors

    2. Perform performance tests, safety tests, efficacy tests, and endotoxin detection test according to ISO 15883-2 requirements

    3. Analyze results and determine whether products meet specific requirements for performance, safety, and efficacy

    Performance Tests

    Performance tests include:

  • Water flow rate

  • Water temperature

  • Detergent concentration

  • Rinsing time

    • Safety Tests

    Safety tests include:

  • Electromagnetic compatibility (EMC)

  • Electromagnetic interference (EMI)

    • Efficacy Tests

    Efficacy tests include:

  • Microbiological testing

  • Chemical analysis

    • Endotoxin Detection Test

    The endotoxin detection test is used to detect the presence of bacterial endotoxins in water.

    Testing and Validation Protocol

    The following steps are involved in the testing and validation protocol:

    1. Select a representative sample of washer-disinfectors

    2. Perform performance tests, safety tests, efficacy tests, and endotoxin detection test according to ISO 15883-2 requirements

    3. Analyze results and determine whether products meet specific requirements for performance, safety, and efficacy

    Conclusion

    Regular testing and validation according to ISO 15883-2 ensures that washer-disinfectors meet specific requirements for performance, safety, and efficacy.

    Implementation Steps

    The following steps are involved in implementing the testing and validation process:

    1. Select a representative sample of washer-disinfectors

    2. Perform performance tests, safety tests, efficacy tests, and endotoxin detection test according to ISO 15883-2 requirements

    3. Analyze results and determine whether products meet specific requirements for performance, safety, and efficacy

    Performance Testing

    Performance testing includes:

  • Water flow rate

  • Water temperature

  • Detergent concentration

  • Rinsing time

    • Safety Testing

    Safety testing includes:

  • Electromagnetic compatibility (EMC)

  • Electromagnetic interference (EMI)

    • Efficacy Testing

    Efficacy testing includes:

  • Microbiological testing

  • Chemical analysis

    • Endotoxin Detection Test

    The endotoxin detection test is used to detect the presence of bacterial endotoxins in water.

    Testing and Validation Protocol

    The following steps are involved in the testing and validation protocol:

    1. Select a representative sample of washer-disinfectors

    2. Perform performance tests, safety tests, efficacy tests, and endotoxin detection test according to ISO 15883-2 requirements

    3. Analyze results and determine whether products meet specific requirements for performance, safety, and efficacy

    Conclusion

    Regular testing and validation according to ISO 15883-2 ensures that washer-disinfectors meet specific requirements for performance, safety, and efficacy.

    Benefits of Implementation

    Implementation of the testing and validation process offers several benefits, including:

  • Improved product quality

  • Enhanced customer confidence

  • Increased market share

  • Reduced regulatory risks

    • Improved Product Quality

    Testing and validation ensure that products meet specific requirements for performance, safety, and efficacy.

    Enhanced Customer Confidence

    Customers trust manufacturers who invest in regular testing and validation.

    Increased Market Share

    Compliance with ISO 15883-2 can result in increased market share and revenue growth.

    Reduced Regulatory Risks

    Non-compliance with ISO 15883-2 can result in serious regulatory consequences, including penalties and fines.

    Conclusion

    Implementation of the testing and validation process ensures that washer-disinfectors meet specific requirements for performance, safety, and efficacy.

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