EUROLAB
iso-13485-sterilization-quality-management
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 14161 Sterilization Process ValidationISO 14162 Packaging for Sterilized Medical DevicesISO 14937 General Requirements for Sterilizer ValidationISO 14937 Sterilization Process Validation RequirementsISO 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

ISO 13485 Sterilization Quality Management Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The International Organization for Standardization (ISO) has established a series of standards to ensure the quality management of medical devices, including ISO 13485:2016, which specifies the requirements for a quality management system (QMS) in the design, development, production, installation, and servicing of medical devices. One of the critical aspects of this standard is sterilization, which is essential to prevent the spread of infection.

Sterilization is defined as the process that removes or destroys all forms of microbial life, including bacteria, viruses, fungi, and spores. The ISO 13485:2016 standard requires medical device manufacturers to implement a sterilization process that meets the specific requirements for their products.

The relevant standards that govern ISO 13485 Sterilization Quality Management testing include:

  • ISO 13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes
  • ISO 11135:2009 - Sterilization of medical devices using ionizing radiation (obsolete)
  • ISO 11137-1:2017 - Sterilization of medical devices -- Radiation -- Part 1: Requirements for validation and routine control
  • ISO 11137-2:2018 - Sterilization of medical devices -- Radiation -- Part 2: Establishing the sterilization dose
  • EN 556-1:2006 - Sterilization of medical devices using ionizing radiation (obsolete)
  • TSE 1330:2015 - Medical devices -- Sterilization by ionizing radiation
  • The standard development organizations involved in this field include:

  • International Organization for Standardization (ISO)
  • Comité Européen de Normalisation (CEN)
  • Turkish Standards Institution (TSE)
  • Standard Requirements and Needs

    The ISO 13485:2016 standard requires medical device manufacturers to establish a sterilization process that meets the specific requirements for their products. The business and technical reasons for conducting ISO 13485 Sterilization Quality Management testing include:

  • Ensuring product safety and efficacy
  • Preventing the spread of infection
  • Meeting regulatory requirements
  • Maintaining customer confidence and trust
  • Enhancing product reliability and performance
  • The industries that require this testing include medical device manufacturers, pharmaceutical companies, and healthcare facilities. The risk factors and safety implications associated with non-compliance to ISO 13485 Sterilization Quality Management standards are significant, including:

  • Product recalls and withdrawals
  • Financial losses due to regulatory fines and penalties
  • Damage to reputation and brand image
  • Compromised product performance and efficacy
  • Risk of infection and harm to patients
  • The quality assurance and quality control aspects of this testing include:

  • Establishing a sterilization process that meets the specific requirements for each medical device
  • Validating and verifying the effectiveness of the sterilization process
  • Monitoring and controlling the sterilization process
  • Maintaining records and documentation related to the sterilization process
  • Test Conditions and Methodology

    The ISO 13485 Sterilization Quality Management testing service provided by Eurolab involves a comprehensive evaluation of the medical devices sterilization process. The test conditions and methodology include:

  • Pre-testing preparation, including sample selection and preparation
  • Testing using ionizing radiation (e.g., gamma or electron beam)
  • Validation of the sterilization dose using biological indicators
  • Measurement and analysis of the sterilization process
  • Calibration and validation of testing equipment and instruments
  • The testing environment requirements include:

  • Temperature control (typically between 20C and 30C)
  • Humidity control (typically between 40 and 60)
  • Pressure control (typically atmospheric pressure)
  • Test Reporting and Documentation

    The test results are documented and reported in a comprehensive report that includes:

  • Summary of the testing conducted
  • Results of the validation and verification of the sterilization process
  • Conclusion and recommendations for improvement
  • The reporting standards and formats used by Eurolab include:

  • ISO 13485:2016 compliant reports
  • Electronic reporting systems (e.g., PDF, Excel)
  • Traceability and documentation requirements
  • Why This Test Should Be Performed

    The benefits of performing the ISO 13485 Sterilization Quality Management testing service provided by Eurolab include:

  • Enhanced product safety and efficacy
  • Compliance with regulatory requirements
  • Improved customer confidence and trust
  • Risk assessment and mitigation through testing
  • Competitive advantages and market positioning
  • Cost savings and efficiency improvements
  • Why Eurolab Should Provide This Service

    Eurolabs expertise and experience in this field include:

  • State-of-the-art equipment and facilities
  • Qualified and certified personnel
  • Accreditation and certification details (e.g., ISO 13485:2016, ISO/IEC 17025)
  • International recognition and partnerships
  • Quality management systems and procedures
  • Conclusion

    The ISO 13485 Sterilization Quality Management testing service provided by Eurolab is a comprehensive evaluation of the medical devices sterilization process. The benefits of performing this testing include enhanced product safety and efficacy, compliance with regulatory requirements, improved customer confidence and trust, risk assessment and mitigation through testing, competitive advantages and market positioning, and cost savings and efficiency improvements.

    References

  • ISO 13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes
  • ISO 11135:2009 - Sterilization of medical devices using ionizing radiation (obsolete)
  • ISO 11137-1:2017 - Sterilization of medical devices -- Radiation -- Part 1: Requirements for validation and routine control
  • EN 556-1:2006 - Sterilization of medical devices using ionizing radiation (obsolete)
  • TSE 1330:2015 - Medical devices -- Sterilization by ionizing radiation
  • Glossary

  • Sterilization: the process that removes or destroys all forms of microbial life
  • Validation: the process of establishing and verifying the effectiveness of a sterilization process
  • Verification: the process of confirming that a sterilization process meets the specific requirements for each medical device
  • Biological indicators: living organisms used to measure the effectiveness of a sterilization process
  • Appendix

  • Table 1: ISO 13485 Sterilization Quality Management testing service provided by Eurolab
  • Figure 1: Sterilization process diagram
  • Figure 2: Testing equipment and instruments
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