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iso-11137-2-sterilization-process-validation-and-bioburden-testing
Endotoxin & Bioburden Testing AAMI RD52 Endotoxin Limits for Dialysis FluidsAATCC TM100 Test for Antimicrobial Activity of TextilesANSI/AAMI ST72 Guidance on Bacterial Endotoxin Testing for Medical DevicesASTM D4414 Bioburden in Coated TextilesASTM D7295 Bioburden Testing on Coated Medical TextilesASTM E2314 Bioburden Testing in Medical Device ComponentsASTM E2406 Real-Time Endotoxin Detection Method ValidationASTM E2614 Bioburden in Industrial Water SystemsASTM E2883 Rapid Endotoxin Detection for Sterile PharmaceuticalsASTM F1608 Bacterial Filtration and Bioburden in Respiratory Protection DevicesASTM F1980 Bioburden Evaluation in Accelerated Aged ProductsASTM F2018 Endotoxin Testing of Contact Lens Care ProductsASTM F640 Bioburden Testing for Surgical DrapesEN 556 Sterilization of Medical Devices – Bioburden LimitsEN ISO 20857 Bioburden Control for Liquid Chemical SterilantsEP 2.6.1 Microbial Testing in Topical PreparationsEP 2.6.12 Microbial Limits Tests for Non-Sterile ProductsEP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical PreparationsEP 2.6.25 Limulus Amebocyte Lysate Test Methods ValidationEP 2.6.30 Endotoxin Testing in Biotechnology ProductsEP 2.6.31 Limulus Amebocyte Lysate Test for EndotoxinsEP 5.1.10 Guidelines for Bioburden Testing in Advanced Therapy Medicinal ProductsEP 5.1.2 Biological Indicators for Sterilization Process ControlEP Monograph 04/2013:20619 Pyrogen and Endotoxin TestingFDA CBER Guidance on Endotoxin Testing of VaccinesFDA CDER Guidance on Bioburden Control in Drug ManufacturingFDA Guidance for Industry on Pyrogen and Endotoxin TestingISO 10993-1 Biological Evaluation of Medical Devices – Endotoxin AssessmentISO 10993-18 Bioburden Interaction with Extractables and LeachablesISO 11138-1 Biological Indicators for Sterilization – Bioburden EvaluationISO 11139 Sterilization Terminology and Bioburden DefinitionsISO 11607 Packaging for Terminally Sterilized Medical Devices – Bioburden ConsiderationsISO 11607-2 Packaging for Terminal Sterilized Devices – Bioburden ConsiderationsISO 11731 Detection of Legionella in Water SystemsISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-1 Bioburden on Reusable Surgical InstrumentsISO 11737-1 Bioburden Testing for Dental ImplantsISO 11737-2 Bioburden Testing for Sterile Barrier SystemsISO 11737-2 Sterility Assurance and Bioburden ControlISO 13408-1 Aseptic Processing Bioburden ControlISO 13408-2 Aseptic Processing Microbiological MonitoringISO 14160 Endotoxin Removal Validation for Sterile LiquidsISO 14161 Bioburden Reduction Using FiltrationISO 14161 Validation of Bioburden Testing MethodsISO 14698-1 Cleanroom Biocontamination Control and MonitoringISO 14971 Risk Management of Endotoxin Contamination in Medical DevicesISO 15883-1 Bioburden Testing for Washer-DisinfectorsISO 17665-1 Moist Heat Sterilization – Bioburden ValidationISO 18562-1 Evaluation of Bioburden in Medical Devices – Part 1ISO 18562-4 Bioburden Testing in Medical Device Gas PathwaysISO 22519 Ultrafiltration Bioburden Reduction TestingISO 29621 Microbiological Examination of CosmeticsISO 80369-1 Endotoxin Limits for Small-Bore ConnectorsISO 80369-7 Small Bore Connectors Bioburden EvaluationISPE Baseline Guide Volume 7 Bioburden Control in Biopharmaceutical ManufacturingJP 15.02 Endotoxin Limit Test for Dialysis FluidsJP 4.05 Bacterial Endotoxin Test for Parenteral DrugsJP 4.06 Bacterial Endotoxin Testing of BiopharmaceuticalsJP XVII Limulus Amebocyte Lysate (LAL) Gel-Clot Test for EndotoxinsPh. Eur. Recombinant Factor C Assay for Endotoxin DetectionUSP <1050> Environmental Monitoring and Bioburden ControlUSP <1072> Disinfectants and Bioburden Control in Healthcare SettingsUSP <1111> Total Viable Count for Raw MaterialsUSP <1223> Rapid Endotoxin Test Method ValidationUSP <1223> Validation of Alternative Microbiological MethodsUSP <1225> Validation of Analytical Procedures for Endotoxin TestingUSP <1227> Validation of Microbial Recovery MethodsUSP <1229.10> Bioburden Testing in Steam SterilizationUSP <1229.12> Endotoxin Risk Assessment in Sterile ManufacturingUSP <1229.4> Microbial Testing for Aseptic Manufacturing EnvironmentsUSP <1229.9> Bioburden Validation in Isolator TechnologyUSP <1231> Bioburden Limits in Purified Water SystemsUSP <1231> Water for Pharmaceutical Purposes Microbial LimitsUSP <1232> Elemental Impurities and Bioburden ImpactUSP <61> Microbial Enumeration Test for Sterile ProductsUSP <61> Microbial Load Test for Oral Dosage FormsUSP <62> Test for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing for Ophthalmic ProductsUSP <800> Bioburden Control in Hazardous Drug CompoundingUSP <85> Bacterial Endotoxin Test for Injectable Pharmaceutical ProductsWHO TRS 1003 Endotoxin Testing Validation for Parenteral Products

ISO 11137-2 Sterilization Process Validation and Bioburden Testing: Eurolabs Laboratory Testing Service

The ISO 11137-2 standard, also known as the Sterilization of Medical Devices - Requirements for Validation and Routine Control - Part 2, is a widely recognized international standard that governs sterilization process validation and bioburden testing. This standard is part of the ISO 11137 series, which provides guidelines for validating and controlling sterilization processes.

Legal and Regulatory Framework

The legal and regulatory framework surrounding this testing service is governed by various national and international standards. In the United States, the Food and Drug Administration (FDA) requires manufacturers to validate their sterilization processes according to the ISO 11137-2 standard. The European Unions Medical Device Regulation (MDR) also references the ISO 11137-2 standard as a requirement for medical device manufacturers.

International and National Standards

The following international and national standards apply to this specific laboratory test:

  • ISO 11137-2:2016 - Sterilization of medical devices - Requirements for validation and routine control - Part 2

  • ASTM E2500-15 - Standard Guide for Characterization of Bioburden on Medical Devices

  • EN ISO 11137-1:2015 - Sterilization of medical devices - Requirements for validation and routine control - Part 1

  • TSE EN ISO 11137-1:2016 - Sterilization of medical devices - Requirements for validation and routine control - Part 1

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is the primary standard development organization responsible for developing and maintaining the ISO 11137 series. Other organizations, such as the American Society for Testing and Materials (ASTM), also contribute to the development of standards related to sterilization process validation and bioburden testing.

    Evolution of Standards

    Standards evolve over time to reflect new scientific discoveries, technological advancements, and changing regulatory requirements. The ISO 11137-2 standard has undergone several revisions since its initial publication in 1995. The most recent revision, published in 2016, introduced significant changes to the sterilization process validation requirements.

    Standard Numbers and Scope

    The following standard numbers and their scopes apply to this specific laboratory test:

  • ISO 11137-1: Sterilization of medical devices - Requirements for validation and routine control - Part 1

    • Covers general principles and requirements for sterilization process validation

  • ISO 11137-2: Sterilization of medical devices - Requirements for validation and routine control - Part 2

    • Covers specific requirements for electron beam (EB) sterilization

  • ISO 11137-3: Sterilization of medical devices - Requirements for validation and routine control - Part 3

    • Covers specific requirements for hydrogen peroxide gas plasma sterilization

    Compliance Requirements

    Compliance with the ISO 11137-2 standard is mandatory for manufacturers of medical devices that undergo sterilization processes. This includes:

  • Medical device manufacturers

  • Sterilization service providers

  • Quality assurance and regulatory bodies

    • Why this specific test is needed and required

    The ISO 11137-2 standard requires manufacturers to validate their sterilization processes to ensure that medical devices are effectively sterilized. This testing is necessary to prevent the introduction of contaminants into the product, which can lead to adverse health effects.

    Business and Technical Reasons

    Conducting ISO 11137-2 Sterilization Process Validation and Bioburden Testing is essential for several business and technical reasons:

  • Ensures compliance with regulatory requirements

  • Prevents product contamination and ensures patient safety

  • Supports quality assurance and control efforts

  • Enhances product reliability and performance

  • Reduces liability and risk exposure

    • Consequences of Not Performing this Test

    Failure to perform ISO 11137-2 Sterilization Process Validation and Bioburden Testing can have severe consequences, including:

  • Product recalls and market withdrawals

  • Regulatory penalties and fines

  • Loss of customer confidence and trust

  • Decreased product reliability and performance

    • Industries and Sectors

    The following industries and sectors require ISO 11137-2 Sterilization Process Validation and Bioburden Testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Healthcare providers and facilities

    • Risk Factors and Safety Implications

    This testing service identifies potential risk factors and safety implications associated with sterilization processes, including:

  • Contamination of medical devices

  • Patient harm and adverse health effects

  • Product recalls and market withdrawals

  • Regulatory penalties and fines

    • Quality Assurance and Control Aspects

    Quality assurance and control are critical components of the ISO 11137-2 standard. Manufacturers must implement quality management systems to ensure that sterilization processes meet regulatory requirements.

    Perspective on Quality

    Effective quality management ensures:

  • Compliance with regulatory requirements

  • Prevention of product contamination

  • Ensuring patient safety

  • Enhancing product reliability and performance

    • Conclusion of Standard Requirements and Needs

    In conclusion, the ISO 11137-2 standard is a critical component of medical device manufacturing. This testing service ensures compliance with regulatory requirements, prevents product contamination, and supports quality assurance and control efforts.

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