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Glossary Term
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ISO 14644 (Cleanrooms and Associated Controlled Environments)

Definition

ISO 14644 is an international standard that establishes guidelines for managing and monitoring contamination in cleanrooms and controlled environments. It focuses on controlling particulate and microbial contamination levels to maintain the sterility and quality of products, particularly in environments critical to healthcare and medical devices.

Relevance to the MedTech Industry

ISO 14644 ensures that cleanrooms used in medical device manufacturing maintain contamination levels within specified limits, protecting device integrity and patient safety. Compliance with the standard is essential for regulatory approval and quality assurance in producing sterile or contamination-sensitive devices.

Additional Information & Related Terms

Key Sections of ISO 14644

  1. ISO 14644-1: Cleanroom Classification

    • Provides criteria for classifying cleanrooms based on the concentration of airborne particles.

  2. ISO 14644-2: Monitoring and Testing

    • Outlines requirements for periodic testing and monitoring of cleanrooms to ensure continued compliance.

  3. ISO 14644-3: Test Methods

    • Details procedures for validating cleanroom performance, including airflow, particle count, and filter integrity tests.

  4. ISO 14644-4: Cleanroom Design

    • Offers guidelines for constructing and commissioning cleanrooms to achieve and maintain specified cleanliness levels.

  5. ISO 14644-5: Operations

    • Provides best practices for operating and maintaining cleanrooms to control contamination during use.

  6. ISO 14644-8 to ISO 14644-17

    • Address specialized topics such as airborne molecular contamination, cleanroom energy efficiency, and risk management.


Related Terms

  • ISO 13485: The standard for medical device quality management systems, which often incorporates cleanroom requirements.

  • Environmental Monitoring: Processes outlined in ISO 14644 to track contamination levels in cleanrooms.

  • Contamination Control: A primary focus of ISO 14644 for maintaining the sterility and quality of medical devices.

  • HEPA Filters: High-efficiency particulate air filters critical for achieving cleanroom standards specified in ISO 14644.

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