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iso-14971-risk-management-of-endotoxin-contamination-in-medical-devices
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 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 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

Comprehensive Guide to ISO 14971 Risk Management of Endotoxin Contamination in Medical Devices Testing Services

ISO 14971 is an international standard that provides a framework for risk management of medical devices. It outlines the principles and processes for identifying, analyzing, evaluating, and controlling risks associated with medical device design, development, testing, production, labeling, packaging, storage, distribution, installation, operation, maintenance, and disposal.

International Standards

  • ISO 14971:2019 Medical devices - Risk management

  • ASTM F2503-19 Standard Guide for Risk Analysis of Medical Devices

  • EN 60601-1:2006A12:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • TSE (Turkish Standards Institution) TS ISO 14971:2019 Medical devices - Risk management

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Electrotechnical Standardization (CENELEC) are some of the standard development organizations involved in developing and maintaining standards related to medical device risk management.

    Evolution of Standards

    Standards evolve over time as new technologies, research findings, and regulatory requirements emerge. Regular updates ensure that standards remain relevant and effective in addressing emerging risks and challenges.

    Scope and Application

    ISO 14971 applies to all medical devices, including active implantable medical devices, active medical devices, and non-active medical devices (e.g., diagnostic equipment).

    Industry-Specific Standards Compliance Requirements

  • Medical device manufacturers must comply with ISO 14971 when designing, developing, testing, producing, labeling, packaging, storing, distributing, installing, operating, maintaining, and disposing of medical devices.

  • Regulatory bodies, such as the FDA in the United States, require compliance with ISO 14971 for medical device approval.

    • Business and Technical Reasons for Conducting ISO 14971 Risk Management

    Medical device manufacturers must conduct risk management to:

    1. Ensure product safety and reliability

    2. Meet regulatory requirements

    3. Protect patients from harm

    4. Maintain competitiveness in the market

    Consequences of Not Performing ISO 14971 Risk Management

    Failure to perform adequate risk management can result in:

    1. Product recalls

    2. Device failures leading to patient injuries or deaths

    3. Regulatory fines and penalties

    4. Loss of business reputation and revenue

    Industries and Sectors Requiring ISO 14971 Testing

    Medical device manufacturers, including those producing diagnostic equipment, implantable devices, and non-active medical devices.

    Risk Factors and Safety Implications

    Endotoxin contamination can lead to:

    1. Device failures

    2. Patient injuries or deaths

    3. Regulatory issues

    Quality Assurance and Quality Control Aspects

    ISO 14971 requires manufacturers to establish a quality management system that includes risk management processes, ensuring that medical devices meet safety and performance requirements.

    Competitive Advantages of Having ISO 14971 Testing Performed

    Companies that conduct ISO 14971 testing can:

    1. Demonstrate compliance with regulatory requirements

    2. Enhance product safety and reliability

    3. Improve customer confidence and trust

    4. Gain competitive advantages in the market

    Cost-Benefit Analysis of Performing ISO 14971 Testing

    While conducting ISO 14971 testing may involve costs, it provides long-term benefits by ensuring product safety, reliability, and regulatory compliance.

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    Step-by-Step Explanation of How the Test is Conducted

    1. Sample preparation

    2. Testing equipment and instruments calibration

    3. Testing environment setup (temperature, humidity, pressure)

    4. Measurement and analysis methods

    5. Data collection and recording procedures

    6. Quality control measures during testing

    Testing Equipment and Instruments Used

  • Endotoxin detection kits (e.g., LAL, Pyrogent, or Chromogenic LAL)

  • Microbiological culture media and equipment

  • Spectrophotometers or other measurement instruments

  • Laboratory information management systems (LIMS)

    • Sample Preparation Procedures

    1. Sample collection from the medical device

    2. Sample preparation for testing (e.g., dilution, extraction)

    3. Verification of sample integrity

    Testing Parameters and Conditions

  • Temperature range: 20-25C

  • Humidity range: 40-60

  • Pressure: atmospheric pressure

  • Sampling frequency: as required by the test plan

    • Measurement and Analysis Methods

    1. Spectrophotometric measurement of endotoxin levels

    2. Microbiological culture methods for endotoxin detection

    3. Data analysis software (e.g., LIMS, Excel)

    Calibration and Validation Procedures

    1. Regular calibration of testing equipment

    2. Validation of testing procedures against established standards

    Quality Control Measures During Testing

    1. Verification of test samples

    2. Monitoring of testing environment conditions

    3. Review of test data for accuracy and completeness

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    ... (rest of the document will be provided upon request)

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