Sterilization of health care products TS EN ISO 17665-1

Steam sterilization validation is a process to verify that steam sterilizers used in hospitals and by medical product manufacturers are operating effectively and reliably. TS EN ISO 17665-1 is an international standard for the application standards for steam sterilization of medical devices.

The main topics of this standard are:
1. Sterilization principles
2. Validation and revalidation procedures
3. Routine control and monitoring
4. Sterilization equipment specifications
5. Sterilization process parameters
6. Documentation, records and training.

Preparing the details of the work to be done and the validation protocol,

Making the product bioburden test before starting to work,

Performing the sterilization process with the same parameters in 3 different cycles in order to demonstrate repeatability,

Performing sterility analyzes of biological indicators placed in the cabinet and the product during the cycles,

Performing sterility analysis of the products after the cycles,

Preparation of the validation report.

Steam sterilization validation is done to verify that a particular sterilization cycle is effective and repeatable for a particular product or product line. The validation process must be carefully planned and implemented to ensure that the product always achieves the desired sterility level.

Sterilization validation usually includes these steps:
1. Process design and specification
2. Performance qualification
3. Routine process control

The TS EN ISO 17665-1 standard describes these steps and requirements in detail so that industry professionals can implement and verify appropriate sterilization procedures.

If you have questions about more specific information or topics, feel free to ask!

Steam Sterilization Validation service is provided in our laboratory within the scope of TS EN ISO 17665-1 standards.