What is ISO 14937-2018

ISO 14937-2018 is a professional technical standard that outlines the requirements for the validation and routine control of sterilization by liquid chemical sterilants used in healthcare facilities. This standard provides guidance on the development, validation, implementation, and maintenance of sterilization processes using liquid chemical sterilants.

Validation of Sterilization Processes

The first step in implementing ISO 14937-2018 is to validate the sterilization process. Validation ensures that the process consistently delivers the desired results by effectively eliminating or reducing microbial contamination. The validation process involves conducting performance qualification tests to verify the effectiveness of the sterilization method under different conditions. These tests evaluate critical parameters such as temperature, contact time, concentration, and compatibility with materials being sterilized.

Routine Control of Sterilization Processes

Once the sterilization process has been validated, routine control measures need to be implemented to ensure ongoing efficacy. This involves monitoring and documenting key parameters during each sterilization cycle, such as temperature, pressure, exposure time, and chemical concentrations. Regular testing, maintenance, and calibration of sterilization equipment are also essential to ensure consistent and reliable results. Any deviations or non-conformances should be promptly addressed and investigated to prevent potential risks to patient safety.

Benefits and Importance of ISO 14937-2018

Compliance with ISO 14937-2018 provides numerous benefits for healthcare facilities. Firstly, it ensures the safety and quality of sterilization processes, thereby reducing the risk of healthcare-associated infections. By following standardized procedures and documentation practices, healthcare facilities can also improve their overall efficiency, reduce errors, and enhance patient care. Additionally, adherence to this standard fosters accountability and assurance, as it provides a recognized framework for regulatory compliance and audits.