EN ISO 17665-2 Sterilization of Health Care Products - Moist Heat Test

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 17665-2 testing. This standard provides general guidance on the development, verification and routine control of moist heat sterilization processes and aims to describe the requirements set out in EN ISO 17665-1. The guidance given in this Technical Specification is provided to encourage good practice in moist heat sterilization processes and to assist those developing and approving moist heat sterilization processes in accordance with EN ISO 17665-1.

Medical devices reprocessed in healthcare facilities include a wide variety of products with varying levels of bioburden. Proper and thorough cleaning prior to sterilization of the product and decontamination where necessary for safe use are essential. Mixed product loads are common in healthcare facilities, with production volumes determined by historical and projected demand for sterile product.

Moist heat is water at high temperatures. Moist heat can be provided as saturated steam or generated in situ by applying thermal energy to water already present in the product. Moisture acts as a medium to transfer thermal energy to microorganisms.

Contaminants suspended in the sterilizing agent can be both toxic and corrosive and create a barrier between the microorganism and the sterilizing agent. They arise from heated or steamed water or from contact between materials and the sterilizing agent during production and transport to the sterilizer. If the level of contaminants in the sterilizing agent can be affected by the quality of the feedwater to the steam generation system, the feedwater quality should be specified.

Process parameters should be valid for the equipment used. They must be optimized to ensure that specified exposure conditions for the identified product families are routinely achieved throughout the sterilizer chamber and that maximum temperatures and rates of change in the process variable (e.g. temperature and pressure) do not cause product damage or deterioration.

The sterilization process specification should include all process parameters that define the exposure profile throughout the operating cycle. It should also include those used to verify repeatability. The portion of the operating cycle in which lethality is established should be defined and the upper and lower limits of each process parameter that can affect both this lethality and the performance of the medical device should be defined.

EUROLAB assists manufacturers with EN ISO 17665-2 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.