ISO 14937 Health Care Sterilization

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ISO 14937 Health Care Sterilization

The ISO 14937 standard has been published by the International Organization for Standards (ISO) to describe the properties of the materials used in the sterilization of healthcare materials, the sterilization process and routine controls. Institute of the Turkish Standards The standard of our country (TSE) has issued the following caption: TS sterilization of EN ISO 14937 health care products - Determination of the characteristics of a sterilizing agent and the development of a sterilization process for medical devices, general requirements for validation and routine control. In fact, this standard is based on a European standard.

ISO 14937 Health Care Sterilization

This standard describes the general requirements for the characterization of a sterilization agent and the development, validation, routine monitoring and control of a sterilization process for medical devices. This standard applies to sterilization processes where microorganisms are inactivated by physical or chemical means. This standard is intended to be applied by process developers, companies producing sterilization equipment, companies producing medical devices to be sterilized, and businesses responsible for sterilizing medical devices.

The ISO 14937 standard also specifies the elements required to ensure proper characterization of a quality management system, sterilization agent, development, validation, routine monitoring and control of the sterilization process. Because the quality management systems standards cannot be fully verified by the effectiveness of the process in the processes used in production, the subsequent inspection and testing of the product.

Exposure to a properly validated and controlled sterilization process is not the only factor to provide assurance that a processed medical device is sterile and is suitable for its intended use. Attention should also be paid to the following factors:

  • Microbiological status of incoming raw materials or components
  • validation and routine control of cleaning and disinfection procedures used in medical devices
  • The medical device manufactured, mounted and packaged as medium control
  • Control of equipment and processes
  • Control and hygiene of staff
  • Packaging and materials of the medical device
  • Conditions under which the medical device is stored

Sterilization testing services of ISO 14937 Healthcare materials are also provided to our businesses within the framework of laboratory testing services.

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