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Glossary Term
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ISO 11138 (Sterilization of Health Care Products – Biological Indicators)

Definition

ISO 11138 is an international standard that specifies requirements for the production, performance, and use of biological indicators in sterilization validation and routine control. Biological indicators are test systems containing viable microorganisms with defined resistance to a specific sterilization process, such as steam, ethylene oxide, or radiation. These indicators help verify that sterilization conditions are effective in achieving a Sterility Assurance Level (SAL) of 10⁻⁶.

Relevance to the MedTech Industry

ISO 11138 ensures that biological indicators are reliable, reproducible, and standardized for use in validating and monitoring sterilization processes. By confirming the effectiveness of sterilization methods, the standard safeguards the sterility and safety of medical devices, reducing the risk of infection or contamination.

Additional Information & Related Terms

Examples of Applications

  • Steam Sterilization: Using biological indicators containing Geobacillus stearothermophilus to validate autoclaving processes.

  • Ethylene Oxide Sterilization: Indicators containing Bacillus atrophaeus to confirm sterilant penetration and process efficacy.

  • Radiation Sterilization: Indicators tailored for gamma or e-beam sterilization processes.

  • Low-Temperature Sterilization: Verifying hydrogen peroxide vapor or plasma sterilization effectiveness.

Key Components of ISO 11138

  1. ISO 11138-1: General Requirements: Describes the overarching principles and requirements for all biological indicators.

  2. ISO 11138-2: Steam Sterilization: Specific guidelines for biological indicators used in steam processes.

  3. ISO 11138-3: Ethylene Oxide Sterilization: Standards for indicators compatible with EtO processes.

  4. ISO 11138-4: Radiation Sterilization: Requirements for indicators in radiation-based sterilization.

  5. ISO 11138-5: Low-Temperature Steam and Formaldehyde: Covers indicators for these specific sterilization methods.

Related Terms

  • Sterility Assurance Level (SAL): The probability of a non-sterile unit, typically 10⁻⁶ for medical devices.

  • ISO 11137: A standard for validating radiation sterilization, often used with biological indicators.

  • Bioburden Testing: Determines the microbial load prior to sterilization, complementing biological indicator use.

  • Ethylene Oxide (EtO) Sterilization: A sterilization method that requires specific biological indicators for validation.

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