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iso-14937-sterilization-process-validation-requirements
Sterilization Validation AAMI ST41 Sterilization Biological IndicatorsAAMI TIR12 Guidelines on EO SterilizationAAMI TIR31 Sterilization Residue LimitsAAMI TIR33 Guidance for Sterilization ValidationANSI/AAMI ST79 Comprehensive Sterilization GuideASTM E2197 Surface Decontamination ValidationASTM E2500 Process ValidationASTM E3139 Sterilization Biological Indicator RecoveryASTM F1608 Biological Indicators for EO SterilizationASTM F1635 Validation of Steam Sterilization CyclesASTM F1929 Integrity Testing of Sterilization PackagingASTM F1960 EO Sterilization Residuals TestingASTM F1980 Accelerated Aging for Sterilized DevicesASTM F1980 Accelerated Aging of Sterilized DevicesASTM F1980 Shelf-Life Validation of Sterilized DevicesASTM F1983 Validation of Steam Sterilization ParametersASTM F1989 Validation of Sterilization BioburdenASTM F2096 Bubble Leak Testing for Sterile PackagesASTM F2118 Validation of Packaging Seal IntegrityASTM F2459 Sterilization Residuals AnalysisASTM F2500 Steam Sterilization Cycle EvaluationASTM F2759 Steam Sterilization Performance EvaluationEN 285 Large Steam Sterilizers ValidationEN 866 Sterilization Chemical IndicatorsEN 867 Biological Indicators for SterilizationEN ISO 11135-1 EO Gas Process ControlEN ISO 17665 Steam Sterilizer Equipment QualificationEN ISO 17665 Sterilization Steam ValidationISO 10993-12 Sample Preparation for Sterilization TestsISO 10993-7 Evaluation of Ethylene Oxide ResiduesISO 11135 EO Gas Sterilization Equipment QualificationISO 11135 Ethylene Oxide Sterilization ValidationISO 11135-1 EO Gas Sterilization Process ControlISO 11135-2 EO Sterilization Process MonitoringISO 11137 Radiation Process ValidationISO 11137 Radiation Sterilization DosimetryISO 11137 Radiation Sterilization ValidationISO 11137-3 Dosimetry System for Radiation SterilizationISO 11138 Biological Indicators for Steam SterilizationISO 11607 Packaging Integrity TestingISO 11607-1 Packaging Material ValidationISO 11607-2 Packaging System ValidationISO 11737 Microbial Limit Testing for SterilizationISO 11737-1 Sterilization Microbiological MethodsISO 11737-2 Sterilization Sterility AssuranceISO 11737-3 Bioburden Testing and EvaluationISO 13408-1 Aseptic Processing ValidationISO 13408-2 Sterile Filtration ValidationISO 13485 Sterilization Equipment QualificationISO 13485 Sterilization Process ControlISO 13485 Sterilization Process QualityISO 13485 Sterilization Quality ManagementISO 14161 Sterilization Process ValidationISO 14162 Packaging for Sterilized Medical DevicesISO 14937 General Requirements for Sterilizer ValidationISO 14971 Risk Management in SterilizationISO 14971 Sterilization Risk AssessmentISO 17665 Steam Sterilizer Performance TestingISO 17665-1 Steam Sterilization ValidationISO 17665-1 Sterilization Cycle DevelopmentISO 17665-2 Steam Sterilization Process Control

Complete Guide to ISO 14937 Sterilization Process Validation Requirements Laboratory Testing Service

Standard-Related Information

ISO 14937 is an international standard that provides a framework for the validation of sterilization processes. The standard outlines the requirements for demonstrating the effectiveness of a sterilization process, ensuring that products are properly sterilized and free from contamination.

Standard Development Organizations

The International Organization for Standardization (ISO) develops and publishes standards in various fields, including laboratory testing and sterilization. ISO 14937 is based on the principles outlined in ISO/IEC 17025, which provides general requirements for the competence of testing and calibration laboratories.

Other relevant standards that govern this testing service include:

  • ASTM E2455: Standard Practice for Validation of Sterilization Processes

  • EN 556-1: Sterilization requirements for medical devices

  • TSE ISO/IEC 17025:2017 Competence of Testing and Calibration Laboratories

    • International and National Standards

    International standards, such as ISO 14937, are used as a reference point by countries to develop their own national standards. For example, in the United States, the FDA uses ASTM E2455 as a reference standard for sterilization process validation.

    National standards may also be developed to meet specific regional or country-specific requirements. In Europe, for instance, the European Committee for Standardization (CEN) develops and publishes standards that are harmonized with ISO standards.

    Compliance Requirements

    Compliance with ISO 14937 requires that laboratories demonstrate their competence in sterilization process validation through a combination of documentation, training, and testing.

    The standard specifies that laboratories must:

  • Develop and implement a quality management system

  • Establish and maintain a calibration program for equipment and instruments used in the testing process

  • Train personnel on the testing procedure and ensure they are aware of the importance of accuracy and precision

  • Use calibrated and validated equipment and instruments to perform the test

  • Follow the standards procedures for sample preparation, testing, and analysis

    • Standard Evolution and Update

    Standards evolve over time as new technologies and techniques become available. The ISO 14937 standard is updated periodically to reflect changes in industry practices and advances in technology.

    The latest revision of ISO 14937 (2018) includes updates on:

  • Improved validation procedures for sterilization processes

  • Enhanced requirements for documentation and record-keeping

  • Increased emphasis on the importance of personnel training and competence

    • Specific Standard Numbers and Their Scope

    Some relevant standard numbers related to ISO 14937 include:

  • ISO/IEC 17025:2017 General Requirements for Competence of Testing and Calibration Laboratories

  • ASTM E2455: Standard Practice for Validation of Sterilization Processes

  • EN 556-1: Sterilization requirements for medical devices

    • Each of these standards provides specific guidance on the validation of sterilization processes, ensuring that products are properly sterilized and free from contamination.

    Standard Requirements and Needs

    ISO 14937 is essential for ensuring the quality and safety of sterilized products. The standards requirements ensure that:

  • Products are properly sterilized to prevent the transmission of diseases

  • The risk of product contamination is minimized

  • Manufacturers can demonstrate compliance with regulatory requirements

    • Business and Technical Reasons for Conducting ISO 14937 Testing

    Conducting ISO 14937 testing provides several benefits, including:

  • Ensuring product safety and quality

  • Minimizing the risk of product contamination

  • Demonstrating compliance with regulatory requirements

  • Improving customer confidence and trust

  • Enhancing market access and trade facilitation

    • Test Conditions and Methodology

    The ISO 14937 standard outlines specific procedures for sterilization process validation. The test conditions and methodology include:

  • Temperature control: Ensure that the sterilization process is carried out at a specified temperature.

  • Humidity control: Maintain a controlled humidity environment to prevent moisture-related issues.

  • Pressure control: Control the pressure in the testing chamber to ensure accurate results.

  • Sample preparation: Prepare samples according to specific procedures outlined in the standard.

    • Testing Equipment and Instruments

    The following equipment and instruments are used for ISO 14937 testing:

  • Autoclaves

  • Sterilization chambers

  • Temperature and humidity control systems

  • Pressure measurement devices

  • Sampling equipment (e.g., syringes, vials)

    • Measurement and Analysis Methods

    Measurements and analysis methods include:

  • Temperature measurements using thermocouples or thermistors

  • Humidity measurements using hygrometers or barometers

  • Pressure measurements using pressure gauges or transducers

  • Microbiological testing to detect any microbial contamination

    • Test Reporting and Documentation

    The test report should include the following information:

  • Description of the sterilization process used

  • Details of the equipment and instruments used for testing

  • Results of the microbiological testing

  • Conclusion on the effectiveness of the sterilization process

    • Interpretation of Test Results

    Interpretation of test results involves evaluating the data collected during the testing process. This includes:

  • Reviewing temperature, humidity, and pressure measurements to ensure that they are within specified limits.

  • Evaluating the results of microbiological testing to determine if any microbial contamination is present.

    • Test Frequency and Retesting

    The standard specifies that retesting should be performed at regular intervals to ensure that the sterilization process remains effective. The frequency of retesting will depend on factors such as product type, production volume, and changes in equipment or procedures.

    Competence of Testing Personnel

    Personnel involved in the testing process must demonstrate competence through training and experience. This includes:

  • Familiarity with the ISO 14937 standard

  • Knowledge of the sterilization process used

  • Understanding of measurement and analysis methods

  • Ability to interpret test results

    • Certification and Accreditation

    Laboratories performing ISO 14937 testing should be certified or accredited by a recognized accreditation body, such as the International Accreditation Forum (IAF) or the American Association for Laboratory Accreditation (A2LA).

    The certification or accreditation process involves:

  • Developing and implementing a quality management system

  • Establishing a calibration program for equipment and instruments used in testing

  • Training personnel on testing procedures and ensuring they are aware of the importance of accuracy and precision

    • By following this complete guide, laboratories can ensure that their sterilization process validation meets the requirements outlined in ISO 14937. This will provide confidence to customers that products are properly sterilized and free from contamination.

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    This document is a comprehensive guide to the ISO 14937 standard for sterilization process validation. It covers standard-related information, standard requirements and needs, test conditions and methodology, measurement and analysis methods, test reporting and documentation, interpretation of test results, test frequency and retesting, competence of testing personnel, certification and accreditation, and more.

    By understanding the requirements outlined in this guide, laboratories can ensure that their sterilization process validation meets the standards necessary for ensuring product safety and quality.

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