BS EN ISO 17665 sets out the requirements to ensure best practice steam sterilisation of medical equipment. By following this standard’s guidelines, the steam sterilisation process is more likely to produce sterile medical instruments on treatment and improve overall quality control. Although BS EN ISO 17665 is limited to medical equipment, its requirements and guidelines can also be applied to other health care products. It’s important to remember that an accurately controlled sterilisation process is not the only factor that ensures a product is sterile.
To improve the performance of steam sterilisation processes, BS EN ISO 17665 looks at the microbiological status of incoming raw materials. It demonstrates the verification and route control of any cleaning and disinfection procedures used on the product. BS EN ISO 17665 also defines the control of the environment where the product is manufactured, assembled and packaged, as well the management of the personnel’s hygiene.
Suppliers of medical equipment
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EN ISO 17665-1:2006
ISO 17665-1:2006