ISO 17665-1 Sterilization of Health Care Products - Moist Heat - Part 1: Development of a Sterilization Process for Medical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 17665-1 testing. ISO 17665-1 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

Moist heat sterilization processes within ISO 17665-1 include, but are not limited to:

• Saturated steam ventilation systems;
• Saturated steam active air evacuation systems;
• air vapor mixtures;
• water spray;
• Immersion in water.

The kinetics of inactivation of a pure culture of microorganisms by physical or chemical agents used to sterilize medical devices can best be described by an exponential relationship between the number of surviving microorganisms and the sterilizing agent and the extent of treatment; inevitably this means that there is always a finite probability for a microorganism to survive, regardless of the extent of treatment administered.

For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and the environment in which the organisms are present at the time of treatment. Therefore, the sterility of any product in a sterilized population cannot be guaranteed, and the sterility of a processed population is defined in terms of the probability that a viable microorganism may be present in a product item.

This section of ISO 17665 describes the requirements to ensure that activities related to the moist heat sterilization process are carried out appropriately. These activities are described in documented work programs designed to demonstrate that the moist heat sterilization process will consistently yield sterile products in treatment with process variables remaining within predetermined limits.

EUROLAB assists manufacturers with ISO 17665-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.