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    Sterilization

    Validated process used to render a device free from viable microorganisms.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Sterilization is a validated process used to render a product free from viable microorganisms. Common modalities include ethylene oxide (EO), gamma radiation, electron beam, and steam.
    What the regulation says
    Under the EU MDR 2017/745, Annex I, Section 11.2 states that devices delivered in a sterile condition must be designed, manufactured, and packed in a non-reusable pack or according to appropriate procedures to ensure they are sterile at the time of use and that sterility is maintained during transport and storage. The FDA, under 21 CFR 820.30, mandates that manufacturers establish and maintain procedures to control product design to ensure that specified design requirements are met, which includes sterilization parameters for sterile devices. ISO 11135, ISO 11137 (parts 1-3), and ISO 17665 (parts 1-2) further provide specific requirements for the development, validation, and routine control of sterilization processes for medical devices using ethylene oxide, radiation, and moist heat, respectively.

    What this means in practice

    FDA has prioritized reducing EO use due to environmental concerns, accelerating adoption of alternative modalities under ISO 11135 and related standards.

    Examples

    • A manufacturer of a novel surgical instrument validates its sterilization process using gamma radiation, following ISO 11137-1 guidelines, to ensure the device is sterile when reaching the operating room.
    • A company manufacturing pre-filled syringes must validate their moist heat sterilization process according to ISO 17665 to ensure the sterility and stability of the drug-device combination product.
    • Prior to launching a new catheter, the MedTech company performs extensive biocompatibility testing and material compatibility studies to confirm the chosen ethylene oxide sterilization method does not degrade the device or leave harmful residues, adhering to ISO 10993 standards.
    Common pitfalls
    • •Failing to re-validate sterilization processes after significant product or process changes can lead to non-sterile devices.
    • •Assuming a sterilization method validated for one device material or design is automatically suitable for another can result in sterilization failures.
    • •Inadequate documentation of sterilization validation and routine process control can lead to regulatory non-compliance during audits.
    • •Choosing a sterilization modality solely based on cost without considering material compatibility and biological safety can compromise device integrity and patient safety.
    • •Not performing routine biological indicator testing or dose audits can obscure a failing sterilization process until a recall is necessary.

    Frequently asked questions

    Sterilization is a process that destroys or eliminates all forms of microbial life, including highly resistant bacterial spores. Disinfection, conversely, reduces the number of viable microorganisms on a surface or in a product but does not necessarily eliminate all microbial forms, especially spores.

    Related terms

    Shared paths + category
    Manufacturing
    Process Validation

    Establishing documented evidence that a process consistently produces conforming output.

    Manufacturing & Supply Chain
    Manufacturing
    Cleanroom Classes (ISO 14644)

    ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9).

    Manufacturing & Supply Chain
    Manufacturing
    Design Transfer

    Translating design into production specifications.

    Manufacturing & Supply Chain
    Quality & Risk
    IQ / OQ / PQ

    Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification.

    Manufacturing & Supply Chain · adjacent
    Standards
    ISO 11135

    Standard for development, validation, and routine control of ethylene oxide (EO) sterilization.

    Manufacturing & Supply Chain · adjacent
    Manufacturing
    Lot Traceability

    Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number.

    Manufacturing & Supply Chain

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    FDA·1ISO·1IMDRF/GHTF·1
    1. 1
      FDA Sterilization
      Verified
      FDAfda.gov
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org

    Inline markers like [1] jump to the matching reference above.