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ansiaami-st72-guidance-on-bacterial-endotoxin-testing-for-medical-devices
Endotoxin & Bioburden Testing AAMI RD52 Endotoxin Limits for Dialysis FluidsAATCC TM100 Test for Antimicrobial Activity of TextilesASTM 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 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

ANSI/AAMI ST72 Guidance on Bacterial Endotoxin Testing for Medical Devices: Eurolabs Laboratory Testing Service

The ANSI/AAMI ST72 Guidance on Bacterial Endotoxin Testing for Medical Devices is a widely recognized standard that provides guidelines for testing medical devices for bacterial endotoxins. This standard is published by the Association for the Advancement of Medical Instrumentation (AAMI) and is based on the principles of ISO 10993-11:2006, which specifies the requirements for testing biological samples to detect pyrogens.

International and National Standards

The ANSI/AAMI ST72 Guidance is based on several international standards, including:

  • ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11: Tests for irritation and skin sensitization

  • ASTM F2029-17, Standard Test Method for Determination of Bacterial Endotoxins in Medical Devices

    • In addition to these international standards, there are several national standards that apply to bacterial endotoxin testing. For example:

  • EU Directive 2007/47/EC, which sets out the requirements for medical devices in the European Union

  • FDA 21 CFR 801, which outlines the regulations for medical devices in the United States

    • Standard Development Organizations

    The standard development organizations that play a key role in developing and maintaining standards related to bacterial endotoxin testing include:

  • AAMI (Association for the Advancement of Medical Instrumentation)

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

    • These organizations work together to develop and maintain standards that are recognized globally.

    How Standards Evolve

    Standards evolve over time as new technologies and research emerge. The ANSI/AAMI ST72 Guidance has undergone several revisions since its initial publication in 1997. These revisions have updated the standard to reflect changes in technology, regulatory requirements, and scientific understanding of bacterial endotoxins.

    Specific Standard Numbers and Scope

    The specific standard numbers that apply to bacterial endotoxin testing are:

  • ANSI/AAMI ST72-2007: Guidance for Testing Bacterial Endotoxins in Medical Devices

  • ISO 10993-11:2006: Biological evaluation of medical devices -- Part 11: Tests for irritation and skin sensitization

  • ASTM F2029-17: Standard Test Method for Determination of Bacterial Endotoxins in Medical Devices

    • The scope of these standards is to provide guidelines for testing medical devices for bacterial endotoxins.

    Standard Compliance Requirements

    Medical device manufacturers are required to comply with the relevant standards and regulations governing bacterial endotoxin testing. This includes:

  • Testing all medical devices that may come into contact with body fluids or tissues

  • Ensuring that testing is performed in accordance with recognized standards (e.g., ANSI/AAMI ST72, ISO 10993-11)

  • Maintaining records of testing results

    • Consequences of Non-Compliance

    Failure to comply with standards and regulations related to bacterial endotoxin testing can result in:

  • Product recalls

  • Regulatory fines and penalties

  • Loss of market share and reputation

  • Patient harm or injury due to contaminated products

    • ---

    Why This Test is Needed

    Bacterial endotoxins are a major concern for medical device manufacturers because they can cause adverse reactions in patients. Endotoxin testing is necessary to ensure that medical devices do not pose a risk to patient health.

    Business and Technical Reasons

    The business and technical reasons for conducting bacterial endotoxin testing include:

  • Ensuring product safety and reliability

  • Maintaining regulatory compliance

  • Building customer confidence and trust

  • Reducing the risk of product recalls and lawsuits

    • Consequences of Not Performing This Test

    Failure to perform this test can result in:

  • Patient harm or injury due to contaminated products

  • Product recalls and regulatory fines

  • Loss of market share and reputation

  • Financial losses due to liability claims

    • Industries and Sectors

    The industries and sectors that require bacterial endotoxin testing include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Hospitals and healthcare organizations

    • ---

    Step-by-Step Explanation of the Test

    The test for bacterial endotoxins involves the following steps:

    1. Sampling: Collecting a sample from the medical device

    2. Sample Preparation: Preparing the sample for testing

    3. Testing: Performing the test using recognized standards (e.g., ANSI/AAMI ST72, ISO 10993-11)

    4. Measurement and Analysis: Measuring and analyzing the results

    Testing Equipment and Instruments

    The testing equipment and instruments used in bacterial endotoxin testing include:

  • LAL (Limulus Amebocyte Lysate) reagents

  • Endotoxin detection kits

  • Spectrophotometers

    • Spectrophotometry

    Spectrophotometry is a technique used to measure the absorbance of light by a sample. In bacterial endotoxin testing, spectrophotometry is used to detect and quantify endotoxins.

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    At Eurolab, we understand the importance of bacterial endotoxin testing for medical device manufacturers. Our expert technicians are trained to perform this test using recognized standards (e.g., ANSI/AAMI ST72, ISO 10993-11). We ensure that all samples are handled and prepared with care to ensure accurate results.

    Our laboratory is equipped with state-of-the-art equipment and instruments to ensure precise measurements and analysis. We maintain strict quality control measures to guarantee the accuracy of our test results.

    Dont risk patient harm or injury due to contaminated products. Trust Eurolab for your bacterial endotoxin testing needs. Our expert technicians are here to help you ensure product safety and reliability.

    ---

    Conclusion

    Bacterial endotoxin testing is an essential requirement for medical device manufacturers. At Eurolab, we understand the importance of this test and are committed to providing accurate and reliable results. Our expert technicians are trained to perform this test using recognized standards (e.g., ANSI/AAMI ST72, ISO 10993-11). We ensure that all samples are handled and prepared with care to ensure accurate results.

    Dont risk product recalls, regulatory fines, or patient harm due to contaminated products. Trust Eurolab for your bacterial endotoxin testing needs. Contact us today to learn more about our services.

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