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en-iso-20857-bioburden-control-for-liquid-chemical-sterilants
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 LimitsEP 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 11137-2 Sterilization Process Validation and Bioburden TestingISO 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

EN ISO 20857 Bioburden Control for Liquid Chemical Sterilants Laboratory Testing Service: A Comprehensive Guide

EN ISO 20857 is a laboratory testing standard that governs the control of bioburden in liquid chemical sterilants. This standard is published by the International Organization for Standardization (ISO) and has been adopted as an European Standard (EN). The standard provides guidelines for laboratories to follow when testing liquid chemical sterilants for bioburden.

Legal and Regulatory Framework

The legal and regulatory framework surrounding EN ISO 20857 bioburden control for liquid chemical sterilants testing is governed by national and international regulations. In the United States, the Food and Drug Administration (FDA) regulates medical devices and pharmaceuticals, including liquid chemical sterilants. The European Unions Medical Device Regulation (MDR) also governs the use of liquid chemical sterilants in medical devices.

International and National Standards

EN ISO 20857 is an international standard that has been adopted by many countries around the world. In addition to EN ISO 20857, other relevant standards include:

  • ASTM E2197: Standard Test Method for Determination of Bioburden on Medical Devices

  • TSE-ISO 11137: Sterilization of health care products Requirements for validation and routine control of sterilization by ionizing radiation

  • ISO 11737-2: Sterility testing of medical devices - Part 2: Sampling plans for extracting samples for bioburden examination

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and publishing international standards, including EN ISO 20857. The European Committee for Standardization (CEN) is also involved in the development of European Standards.

    Evolution and Updates of Standards

    Standards are constantly evolving to reflect changes in technology, regulations, and industry practices. EN ISO 20857 has undergone several revisions since its initial publication in 2006.

    Standard Numbers and Scope

    EN ISO 20857:2019 is the current version of the standard, which provides guidelines for laboratories to follow when testing liquid chemical sterilants for bioburden.

    Compliance Requirements for Different Industries

    Different industries have varying compliance requirements for EN ISO 20857 bioburden control for liquid chemical sterilants testing. For example:

  • Medical devices: EN ISO 20857 is required for medical devices that are treated with liquid chemical sterilants.

  • Pharmaceutical industry: The standard is used to test liquid chemical sterilants used in pharmaceutical manufacturing.

    • EN ISO 20857 bioburden control for liquid chemical sterilants testing is a critical requirement for many industries. The standard provides guidelines for laboratories to follow when testing liquid chemical sterilants for bioburden.

    Business and Technical Reasons for Conducting EN ISO 20857 Testing

    The business and technical reasons for conducting EN ISO 20857 testing include:

  • Ensuring product safety and reliability

  • Complying with regulatory requirements

  • Maintaining quality assurance and control

  • Reducing risk factors and safety implications

    • Consequences of Not Performing This Test

    Failure to perform EN ISO 20857 testing can result in:

  • Non-compliance with regulations

  • Product contamination and failure

  • Customer dissatisfaction and loss of business

    • Industries and Sectors that Require this Testing

    EN ISO 20857 bioburden control for liquid chemical sterilants testing is required by various industries, including:

  • Medical devices

  • Pharmaceutical industry

  • Biotechnology

  • Food processing

    • Risk Factors and Safety Implications

    Liquid chemical sterilants can pose risks to human health and the environment if not properly controlled. EN ISO 20857 testing helps mitigate these risks.

    Quality Assurance and Quality Control Aspects

    EN ISO 20857 testing is an essential component of quality assurance and control programs for industries that use liquid chemical sterilants.

    Contributions to Product Safety and Reliability

    EN ISO 20857 testing contributes to product safety and reliability by ensuring that liquid chemical sterilants are free from bioburden.

    Competitive Advantages and Cost-Benefit Analysis

    Performing EN ISO 20857 testing provides competitive advantages, including:

  • Compliance with regulations

  • Reduced risk factors and safety implications

  • Improved product quality

    • The cost-benefit analysis of performing EN ISO 20857 testing shows that the benefits far outweigh the costs.

    EN ISO 20857 bioburden control for liquid chemical sterilants testing involves several steps, including:

  • Sample preparation

  • Testing equipment and instruments used

  • Testing environment requirements (temperature, humidity, pressure, etc.)

  • Measurement and analysis methods

  • Calibration and validation procedures

    • EN ISO 20857 bioburden control for liquid chemical sterilants testing requires accurate reporting and documentation. The standard provides guidelines for laboratories to follow when preparing test reports.

    Why Choose Our Laboratory Testing Services?

    Our laboratory is equipped with state-of-the-art equipment and follows strict quality control procedures to ensure that EN ISO 20857 bioburden control for liquid chemical sterilants testing is performed accurately and efficiently.

    We provide comprehensive testing services, including:

  • Sample preparation

  • Testing

  • Reporting

    • Our experienced staff are committed to delivering high-quality results on time.

    Conclusion

    EN ISO 20857 bioburden control for liquid chemical sterilants testing is a critical requirement for many industries. Our laboratory provides comprehensive testing services that ensure compliance with regulations and industry standards. Contact us today to learn more about our EN ISO 20857 testing services.

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